Marcel de Grutter is a longtime expert in Serialization and leading member of the Open SCS initiative. Join his Keynote speech for the formal release of the Open SCS Serialization Reporting Specification.
First time public persentation – a must attend!
Marcel de Grutter is a longtime expert in Serialization and leading member of the Open SCS initiative. Join his Keynote speech for the formal release of the Open SCS Serialization Reporting Specification.
First time public persentation – a must attend!
TRACKTS! 2017 – Track & Trace redefined – Serialization Now! 2017 brings the best case studies and most innovative ideas together in a highly interactive program that has been designed to ensure maximum learning and knowledge exchange. Get the most out of your invested time!
TRACKTS! 2017 – Track & Trace redefined – Serialization Now! 2017 brings the best case studies and most innovative ideas together in a highly interactive program that has been designed to ensure maximum learning and knowledge exchange. Get the most out of your invested time!
With the support of major influencers and leading stakeholders, we are working to uncover the real needs and challenges end users are facing.
With the support of major influencers and leading stakeholders, we are working to uncover the real needs and challenges end users are facing.
Over 25 years’ experience in Pharmaceuticals, held various positions and roles. Actively involved in many reorganizations, integrations and separation after takeovers and business split. Respected Expert in MOMS, Operations and Logistics and able to translate the requirements of the Business to practical cost effective, innovative Automation and IT solutions. Active in various User Groups like Senior Oversight Group Coding and Serialization of EFPIA and presenter/panel member at many congresses.
Case Study
Update on the Open-SCS Initiative
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries. Abbott Nutrition is a division of Abbott, the global, broad-based health care company. Health care professionals and their patients trust us to provide cutting-edge nutrition products that meet changing nutrition needs.
Marco Glauner is co-founder and managing partner of prime4services, working as an acknowledged expert and senior consultant for pharmaceutical manufacturing topics with numerous players in the pharmaceutical arena. Over the past 20 years, he built up his expertise through various positions at supplier and service companies, always focussing on life science industries with his work.
Marco’s key expertise is in areas of MES and T&T systems, bundled with his know-how on business process analysis, system landscape design & harmonisation, deployment & operations methodologies, project/program management and system validation.
World class through Efficiency & Transparency
Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.
We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.
Use our skills and rich experience for your benefit!
Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.
The „real“ implementation practice at DSM Sinochem Pharmaceuticals of the Serialisation solution of SAP ATTP in conjunction with the Pharma Network.
Since April 2014, Robert Jan van der Horst is IT Director at DSM Sinochem Pharmaceuticals. Before taking over this role, he was Business Information Manager at DSM Sinochem Pharmaceuticals.
From February 2001 to January 2012, Robert Jan had different roles within DSM Anti-Infectives; starting with Business Systems Manager (2001-2006), then working as SAP System Validation and cGMP Expert (2006-2009), and finally as Business Information Manager (2009-2012).
From 1998 to 2001 Robert Jan was ICT Project Manager at DSM.
In his Case Study presentation, Robert Jan van der Horst will present one of his current Serialization projects at DSM Sinochem. We will learn about the pro and cons of an isolated vs. a connected working environment and the requirements that have to be met in terms of architectural landscape and communication layers. This project is ongoing, outcome yet tbc. but definitely a story to tell.
Since April 2014, Robert Jan van der Horst is IT Director at DSM Sinochem Pharmaceuticals. Before taking over this role, he was Business Information Manager at DSM Sinochem Pharmaceuticals.
From February 2001 to January 2012, Robert Jan had different roles within DSM Anti-Infectives; starting with Business Systems Manager (2001-2006), then working as SAP System Validation and cGMP Expert (2006-2009), and finally as Business Information Manager (2009-2012).
From 1998 to 2001 Robert Jan was ICT Project Manager at DSM.
Case Study
The „real“ implementation practice at DSM Sinochem Pharmaceuticals of the Serialisation solution of SAP ATTP in conjunction with the Pharma Network.
Royal DSM N.V. is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext.
Last developments in the OPEN Serialization Communication Standard Workgroup
Over 25 years’ experience in Pharmaceuticals, held various positions and roles. Actively involved in many reorganizations, integrations and separation after takeovers and business split. Respected Expert in MOMS, Operations and Logistics and able to translate the requirements of the Business to practical cost effective, innovative Automation and IT solutions. Active in various User Groups like Senior Oversight Group Coding and Serialization of EFPIA and presenter/panel member at many congresses.
Marcel de Grutter is a leading member of The OPEN-SCS working group and heavily involved in their achievements in the field of Serialization Communication Standards. Marcel will give an overview on the foundational meaning of the OPEN-SCS and their current organization and members. He will also give a glimpse at their last achievements and introduce the audience to Work Product 1.0. Futhermore, Marcel will draft the roadmap and give a hint on the future of OPEN-SCS‘ work and will explain why and how to join.
Over 25 years’ experience in Pharmaceuticals, held various positions and roles. Actively involved in many reorganizations, integrations and separation after takeovers and business split. Respected Expert in MOMS, Operations and Logistics and able to translate the requirements of the Business to practical cost effective, innovative Automation and IT solutions. Active in various User Groups like Senior Oversight Group Coding and Serialization of EFPIA and presenter/panel member at many congresses.
Case Study
Update on the Open-SCS Initiative
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries. Abbott Nutrition is a division of Abbott, the global, broad-based health care company. Health care professionals and their patients trust us to provide cutting-edge nutrition products that meet changing nutrition needs.
Smart Packaging enabling the Internet of Things: Consumer - Product Interaction Through NFC Technology.
Dr. Paolo Bavaj is Head of Corporate Venturing for Henkel Adhesive Technologies.
He joined the Adhesive Technologies business unit of Henkel AG & Co. KGaA as Corporate Director Strategy and Business Development in December 2010. In April 2013, he became Head of New Business Development, with responsibility for identifying and evaluating innovation opportunities through strategic Foresight Management, Scouting, Start-up Screening, Venturing and Incubation.
He joined Celanese Chemicals in 1996, where he worked in Operations, New Business Development and led then a global R&D and New Business Development team, gained experience as Area Sales Manager in the United States, and ran the Celanese Emulsions Textile and Engineered Fabrics business in Europe as well as their global Glass Fiber business.
Paolo holds a PhD in Chemical Engineering from RWTH Aachen, Germany.
Paolo will introduce us to the latest trends in „Smart Packaging enabling the Internet of Things: Consumer - Product Interaction Through NFC Technology“. This benchmark presentation will not only give an overview of the basic and future technologies being used in the packaging industry. Paolo will outline how to set up an entire ecosystem around smart packaging to drive the pharma industry towards the Internet of Things and true interaction with their customers.
Dr. Paolo Bavaj is Head of Corporate Venturing for Henkel Adhesive Technologies.
He joined the Adhesive Technologies business unit of Henkel AG & Co. KGaA as Corporate Director Strategy and Business Development in December 2010. In April 2013, he became Head of New Business Development, with responsibility for identifying and evaluating innovation opportunities through strategic Foresight Management, Scouting, Start-up Screening, Venturing and Incubation.
He joined Celanese Chemicals in 1996, where he worked in Operations, New Business Development and led then a global R&D and New Business Development team, gained experience as Area Sales Manager in the United States, and ran the Celanese Emulsions Textile and Engineered Fabrics business in Europe as well as their global Glass Fiber business.
Paolo holds a PhD in Chemical Engineering from RWTH Aachen, Germany.
Industry benchmark
Smart Packaging enabling the Internet of Things: Consumer - Product Interaction Through NFC Technology
Henkel operates globally with a well-balanced and diversified portfolio. The company holds leading positions with its three business units in both industrial and consumer businesses thanks to strong brands, innovations and technologies. Henkel Adhesive Technologies is the global leader in the adhesives market – across all industry segments worldwide. In its Laundry & Home Care and Beauty Care businesses, Henkel holds leading positions in many markets and categories around the world. Founded in 1876, Henkel looks back on more than 140 years of success. Henkel employs more than 50,000 people globally – a passionate and highly diverse team, united by a strong company culture, a common purpose to create sustainable value, and shared values. As a recognized leader in sustainability, Henkel holds top positions in many international indices and rankings. Henkel’s preferred shares are listed in the German stock index DAX.
Technical Overview for the Approved OPEN-SCS Work Product 1.0 Specifications
Technical Director/Founder of the OPEN-Serialization Communication Standard (SCS) Working Group.
BSs in Chemical and Material Engineering, MS in Solid State Physics from Univ. of Maryland.
As TQM Facilitator and Process Action Team Leader of over 28 years, Mr. Gifford led and designed MES, operations management, and supply chain system projects to part of planned intelligent manufacturing transformation across 12 industries and 80 plants. As international recognized chair and author of intelligent manufacturing standards for over 25 years such as International Society Automation, OPC Foundation, OPEN-SCS WG, Open Application Group, Supply Chain Council and MESA International. Authored, applied and taught many of today’s applied intelligent manufacturing operations standards (ISA-88, ISA-95, OAGIS, SCOR, others).
An internationally recognized teacher and author of 5 books, over 50 papers, and 20 courses on combining continuous improvement practices with intelligent manufacturing operations management systems. ISA’s Best Standard Book of Year 2011, 2013.
Charlie Gifford is a leading member of The OPEN-SCS working group and heavily involved in their achievements in the field of Serialization Communication Standards. During his Closing Keynote, Charlie will explain, why a standard in data exchange is critical for healthcare packaging serialization. He will present Work product 1.0 Use Cases and speak about the related deliverables‘ specifications. Learn to what extend agile development was and still is a key success factor and what is already in store regarding the planning of Work product 2.0.
Technical Director/Founder of the OPEN-Serialization Communication Standard (SCS) Working Group.
BSs in Chemical and Material Engineering, MS in Solid State Physics from Univ. of Maryland.
As TQM Facilitator and Process Action Team Leader of over 28 years, Mr. Gifford led and designed MES, operations management, and supply chain system projects to part of planned intelligent manufacturing transformation across 12 industries and 80 plants. As international recognized chair and author of intelligent manufacturing standards for over 25 years such as International Society Automation, OPC Foundation, OPEN-SCS WG, Open Application Group, Supply Chain Council and MESA International. Authored, applied and taught many of today’s applied intelligent manufacturing operations standards (ISA-88, ISA-95, OAGIS, SCOR, others).
An internationally recognized teacher and author of 5 books, over 50 papers, and 20 courses on combining continuous improvement practices with intelligent manufacturing operations management systems. ISA’s Best Standard Book of Year 2011, 2013.
Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products. The open standard and work products are focused on the standardization of data exchanges for Healthcare packaging serialization and the aggregations between a Healthcare provider’s enterprise serialization management function and their product packaging lines. This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management). The scope of the 2016/17 work products focuses on data exchanges for 6 proposed use cases in two data exchange categories: 1. Mandatory Services and 2. Support Services which are addressed in 6 common Packaging Line Serialization System Configurations.
Over 25 years’ experience in Pharmaceuticals, held various positions and roles. Actively involved in many reorganizations, integrations and separation after takeovers and business split. Respected Expert in MOMS, Operations and Logistics and able to translate the requirements of the Business to practical cost effective, innovative Automation and IT solutions. Active in various User Groups like Senior Oversight Group Coding and Serialization of EFPIA and presenter/panel member at many congresses.
Case Study
Update on the Open-SCS Initiative
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries. Abbott Nutrition is a division of Abbott, the global, broad-based health care company. Health care professionals and their patients trust us to provide cutting-edge nutrition products that meet changing nutrition needs.
Jyrki Syväri, Pharmacist and Chemist, made his PhD Theses in Pharmaceutical Chemistry and his Diploma in Chemistry in Analytical Chemistry. He joined Boehringer Ingelheim to become a Project Manager in Operations. He was responsible for the world-wide launches of new products, such as Metalyse and Spiriva. Thereafter he was heading a group called “Launch and Special Supplies”. In this function he was responsible for setting up supply chains for Boehringer Ingelheim’s new products. New Supply Chain paradigms and concepts fell also under his responsibility. In this context he became the world-wide program leader for BI’s Product Safety & Security project that centres around serialisation. Additionally, Jyrki is leading the global initiative Supply Chain Integrity which takes a broader view on supply chain security, transparency and Risk Management.
Keynote
GO LIVE Serialization - 5Ws Stress test for your company: Is your orgnization fit for mandatory Serialization?
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Still headquartered in Ingelheim, it operates globally with 146 affiliates and more than 47,700 employees. The company's key assets of interest are: respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. Boehringer Ingelheim is a full member of the European Federation of Pharmaceutical Industries and Associations EFPIA.
Since April 2014, Robert Jan van der Horst is IT Director at DSM Sinochem Pharmaceuticals. Before taking over this role, he was Business Information Manager at DSM Sinochem Pharmaceuticals.
From February 2001 to January 2012, Robert Jan had different roles within DSM Anti-Infectives; starting with Business Systems Manager (2001-2006), then working as SAP System Validation and cGMP Expert (2006-2009), and finally as Business Information Manager (2009-2012).
From 1998 to 2001 Robert Jan was ICT Project Manager at DSM.
Case Study
The „real“ implementation practice at DSM Sinochem Pharmaceuticals of the Serialisation solution of SAP ATTP in conjunction with the Pharma Network.
Royal DSM N.V. is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext.
Solution Study
T&T is in place – and now comes the hard part - actually operating efficiently and understanding the true impact of ownership
Challenge your Peers
Industry 4.0 and Track & Trace
World class through Efficiency & Transparency
Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.
We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.
Use our skills and rich experience for your benefit!
Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.
Michael Ventura, Director, Industry Solutions, TraceLink - Michael joins TraceLink following a 30-year career as the former serialisation and security lead for GlaxoSmithKline (GSK) in the Americas, including 8 years as an active GS1 Global and GS1 US member, where he currently serves as an elected member of the GS1 US Executive Leadership Team and co-chair of the traceability team. While at GSK, he led the company’s patient safety and fraud prevention efforts and provided guidance on implementing effective solutions for EMR development, SMS patient authentication, point-of-dispense authentication, and full traceability pilots. In his new role, Michael will lead strategic discussions with pharmaceutical companies that face significant infrastructure and operational challenges in meeting global track and trace compliance deadlines, and provide practical insight to manufacturers that are working to put successful serialisation strategies in place over the next two to three years.
World Café
Setting the Scenes for Efficient Serialization Strategies: How to Organize Conception, Planning and Implementation?
TraceLink is the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace. Leading businesses, including 16 of the top-20 global pharmaceutical companies, trust the TraceLink Life Sciences Cloud to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to comply to track and trace regulatory requirements anywhere in the world, and improve performance across global supply, manufacturing and distribution operations. Winner of numerous industry awards including the Amazon AWS Global Start-Up Challenge Grand Prize and the Edison Award for Innovation in Health Management, the TraceLink Life Sciences Cloud is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost.
acing the Challenges, How Using Standards For Serialization Can Bring Real Business Benefits
Chemist by education. (PhD in analytical chemistry and MBA)
More than 15 years of experience in Pharma industry (from TEVA to greenfield venture; from R&D to QC)
Since 2014 with Tradeticity.
Solution Study
An update and perspective of Quality in a shifting and heterogeneous regulatory landscape, and its impact on pharmaceutical serialization
Tradeticity provides cost-effective serialisation solutions, designed from the ground-up with quality compliance in mind. Our system is in accordance with GAMP 5, and is capable of end-to-end serialisation (to be compliant with the EU Directive 2011/62/EU) and full, item-level Track and Trace. Whilst the final solution we provide is bespoke for our client’s needs, the core system is standard, therefore easy to document and maintain compliance.
Our team was assembled solely for this purpose, and includes IT specialists, and pharmaceutical compliance specialists who have many years’ experience at the biggest software and pharmaceutical companies in the World, giving us a deep understanding of the challenges faced.
We are proud to be a Croatian company, giving easy access to pharmaceutical manufacture in South-East Europe, but equally we have an International presence, with offices in US, Brazil and UK.
Jean-Marie is a visionary leader with more than 20 years of experience dedicated to building and delivering technology solutions that protect patients, ensure product integrity and improve business performance. Currently playing a pivotal role in TraceLink’s global expansion, Jean Marie is leading the EMEA operations to build collaborative relationships with Pharmaceutical companies and help improve traceability of medicines across the Life Sciences supply chain. Jean Marie has held several successful leadership roles spanning through 15 years of serving companies in the Life Sciences industry. At Abbott Diagnostics, he led development of enterprise solutions to help improve business processes. Before joining Abbott Diagnostics, he helped Phase Forward become a market leader in Europe, holding senior sales roles prior to and following Phase Forwards acquisition by Oracle. Jean Marie started in Life Sciences at Aster Cephac where he focused on contract research. Originally a native of France, he holds a master’s degree in business from the Center d’Etudes Supérieures de Management International (CESMI, ISG group).
TraceLink is the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace. Leading businesses, including 16 of the top-20 global pharmaceutical companies, trust the TraceLink Life Sciences Cloud to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to comply to track and trace regulatory requirements anywhere in the world, and improve performance across global supply, manufacturing and distribution operations. Winner of numerous industry awards including the Amazon AWS Global Start-Up Challenge Grand Prize and the Edison Award for Innovation in Health Management, the TraceLink Life Sciences Cloud is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost.
In 2014, Frank Thönnissen joined Videojet Technologies GmbH. In his position as Salesmanager Pharma DACH he is in charge of Business Development Pharma/OEM in region Germany/Austria/Switzerland.
His expertise is in the field of coding/serialization for all kinds of applications in the pharma/packaging industry.
Before Frank performed various Sales and Management roles in the Document-Management- & IT-Solutions industry. In addition, Frank worked as a Management Consultant on Business Development and Marketing projects.
Challenge your Peers
Underestimated key criteria for high-quality coding to comply with DSCSA, UDI and FMD requirements
Videojet Technologies is a world leader in industrial coding and marking solutions with a dedicated global pharmaceutical team supporting organizations and supply chain partners with solutions, certifications and fast, reliable service. A product portfolio including thermal inkjet, laser marking, continuous inkjet and labeling provides consistent, high-quality serialization and traceability codes, helping the pharmaceutical and medical device industries safeguard their products against counterfeiting and protect consumer safety. With a wide range of technologies addressing virtually any application, Videojet is the expert in realizing the specific requirements of a wide range of healthcare applications.
With decades of knowledge, Videojet Technologies’ expertise in industry standards and global regulations makes them the right partner for understanding complex coding needs. Videojet solutions code 10 billion products a day worldwide, playing a vital and responsible role in the world. With over 4,000 associates serving 135 countries, Videojet has the capability to provide local service through global resources.
Dipl Wirtschaftsingenieur FH Darmstadt
etwa 7 Jahre Freelance- und Interimsprojektmanager im Bereich Kennzeichnung (Auto-ID/Barcode) und Produktionsplanung /-optimierung
etwa 2 Jahre Projektmanager bei Mettler Toledo PCE (Serialisierungslieferant)
Seit Mai 2016 Projektmanager im globalen Track&Trace-Programm von Fresenius Kabi, verantwortlich für den globalen Roll-out und Unterstützung der Werke bei diesem
IT Challenges Café
How to handle individual process requirements in a standardized TT solution interface environment?
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.
Our product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Within transfusion technologies, Fresenius Kabi offers products for collection and processing of blood components and for therapeutic treatment of patient blood by apheresis systems.
In 2016 the company reported sales of €6 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.
Benchmark Pharma - Creating a local to global template for Track & Trace in Manufacturing: Process Control improvements through subsequent roll-outs for better plant stability and better plant performance on a global scale.
Same but different, Risk assessment vs. Regulatory: Similarities and Differences in Pharma and Plastics Engineering and how they affect process development
Culture defined by Compliance: Making the change from a merely business driven company culture to creating a fully compliant working environment
Implementation 360°: Improving the company environment will improve work processes on the shop floor, in administration (supply chain, control, manufacturing) and integrating existing IT tools
Mastering challenges on a global level: How to deal with (not only technical IT) issues during Development, Testing and Implementation
DSM Engineering Plastics is a global supplier of high-performance engineering thermoplastic solutions. It has a focused portfolio, with global leadership positions in many of its products in the areas of high-performance plastics, such as Stanyl®, Arnite® and Akulon®. DSM Engineering Plastics addresses key markets in automotive and electronics, and provides solutions to specialized industries including water management, breathable textiles and flexible food packaging.
Staffan Widengren has been working in the pharmaceutical industry since 1988. He started his career within Quality at Kabi and Pharmacia, working as QA manager and Qualified Person. In 2002, Staffan changed companies, taking over the position of QA/QC Director and Qualified Person at Recip (Recipharm). From 2007 until 2015, Staffan held the position of General Manager at Recipharm Strängnäs, before moving on to becoming Programme manager for Recipharm Global serialization project at Recipharm AB.
Case Study
Stearing towards a global serialization programme – Opportunities and challenges for a CDMO.
Roadmap for Project Serialization: Allocating resources, setting up a timeline and developing an action plan.
Opportunities – Using serialization to drive your company past the competition
Implementing full Serialization as competitive advantage: Not everyone can afford to take on the projects.
Time to market as a crucial factor: Avoiding increasing lead times and delays in equipment delivery.
Challenges – Pitfalls to cakein to account and overcome.
Up front investements or flat fee: Negotiating with your customers and suppliers.
Defining the scale of your portfolio: Serialization & Aggregation I Standardized versus Customized: Which products & services can you offer in the designated time given?
Onboarding your customers: How much time is enough to have all your clients up and running?
Being compliant in all matters with increasing regulatory around the globe: How to set up reporting to fulfill directives and comply with acts?
Recipharm is a partner for contract pharmaceutical development and manufacturing. With production facilities across Europe, recipharm is uniquely positioned to deliver reliable and flexible service for all their customers, wherever they are.
Recipharm supplies several hundred different products in a variety of dosage forms including solid dose, semi solids, steriles (liquids and freeze dried), beta-lactams, hormones, dry powder inhalers and granulates, from our various facilities across Europe. Recipharm’s Pharmaceutical Development Services group activities range from straight forward clinical supply through to more complex product development and formulation. From their pharmaceutical development centre they can work on a variety of technologies (including sterile products). Formulation Development, Clinical Supplies, Analytical Development, Stability Studies, Packaging Development and Raw Material Selection are all core activities.
Dr. Paolo Bavaj is Head of Corporate Venturing for Henkel Adhesive Technologies.
He joined the Adhesive Technologies business unit of Henkel AG & Co. KGaA as Corporate Director Strategy and Business Development in December 2010. In April 2013, he became Head of New Business Development, with responsibility for identifying and evaluating innovation opportunities through strategic Foresight Management, Scouting, Start-up Screening, Venturing and Incubation.
He joined Celanese Chemicals in 1996, where he worked in Operations, New Business Development and led then a global R&D and New Business Development team, gained experience as Area Sales Manager in the United States, and ran the Celanese Emulsions Textile and Engineered Fabrics business in Europe as well as their global Glass Fiber business.
Paolo holds a PhD in Chemical Engineering from RWTH Aachen, Germany.
Industry benchmark
Smart Packaging enabling the Internet of Things: Consumer - Product Interaction Through NFC Technology
Henkel operates globally with a well-balanced and diversified portfolio. The company holds leading positions with its three business units in both industrial and consumer businesses thanks to strong brands, innovations and technologies. Henkel Adhesive Technologies is the global leader in the adhesives market – across all industry segments worldwide. In its Laundry & Home Care and Beauty Care businesses, Henkel holds leading positions in many markets and categories around the world. Founded in 1876, Henkel looks back on more than 140 years of success. Henkel employs more than 50,000 people globally – a passionate and highly diverse team, united by a strong company culture, a common purpose to create sustainable value, and shared values. As a recognized leader in sustainability, Henkel holds top positions in many international indices and rankings. Henkel’s preferred shares are listed in the German stock index DAX.
Opening Keynote
Track&Trace beyond compliance: Creating Business Value building business strategy around T&T implementation
For over 30 years, all our resources have been channeled in a single direction: to provide innovative medical dermatological solutions that meet the needs of patients and physicians with a particular focus on acne, rosacea, psoriasis and other steroid-responsive dermatoses, onychomycosis (fungal nail infections), pigmentary disorders, skin cancer and medical aesthetic and corrective solutions for skin senescence. The skin conditions we treat can have strong psychological and social implications in the everyday lives of our patients. By treating these conditions, we help people preserve, restore and maintain healthy skin and improve their quality of life.
Today, Galderma is a global dermatology company partnering with healthcare professionals to provide innovative medical solutions to patients with skin health needs. The company has 35 wholly-owned affiliates and a worldwide network of distributors, over 6 000 employees and an extensive product portfolio available in more than 100 countries.
Galderma’s R&D is continually dedicated to finding new medical solutions, offering physicians more options and offering patients a better quality of life. Five state-of-the-art R&D centers and six manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy.
Martin Rasmussen is the Global lead on serialisation activities in Lundbeck; His overall responsibility is to secure that Lundbeck is in compliance with legislation globally on serialisation and track & trace. He establishes plans and cross organisational alignment on activities to be in compliance with future legislation when implemented. Along that, Martin Senior Project Manager Product Introduction; Establish supply chain for new products, new markets, and life cycle management of existing products.
Martin is a subject matter expert for injection devices, he engages in support activities in SOE, R&D and Marketing on injection devices.His current focus lies on project proposals for EU’s Framework Programme for Research and innovation.
2014 H. Lundbeck A/S, Global Supply Chain, Senior Project Manager, Product Introduction
2013-2014 Novo Nordisk A/S Device R&D, Senior R&D Systems engineer and team coordinator.
2009-2013 Novo Nordisk A/S Device R&D, Lead engineer, mechanical design and team coordinator.
2006-2009 IPU Product Development, Engineering Consultant.
2005-2006 PERA Innovation UK, Project consultant and R&D engineer.
Education
1999-2005 Master of Science in Engineering, Technical University of Denmark. Degree in mechanical design and applied mechanics.
Case Study
It always starts with one plant – What can big companies learn from SMEs?
Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disease areas such as depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease.
According to the World Health Organization, WHO, more than 700 million cases of psychiatric and neurological disorders are reported every year. These are serious and life-threatening diseases that affect the quality of life of the patients as well as of their relatives.
As these diseases also involve major socio-economic costs, it is imperative for the general society that new and innovative pharmaceuticals are developed. Over the past 50 years, new pharmaceuticals have revolutionised the treatment options, but there remains a large unmet need for new and innovative therapeutics.
Focus on R&D is the most important pillar in Lundbeck’s ambition to improve treatment for people living with psychiatric and neurological disorders. We are specialists in our area and have research facilities in Denmark and China, and more than 1,000 employees work in our R&D units. We cooperate closely with strategic partners all over the world, ensuring the best possible foundation for innovation and the development of new treatment solutions.
Lundbeck employs approximately 5,300 people worldwide, 1,700 of whom are based in Denmark. We have employees in 55 countries, and our products are registered in more than 100 countries. We have production facilities in China, Denmark, France and Italy and research centres in Denmark and China.
Since March 2017, Michael Völlinger has been Business Process Owner Serialization, Track&Trace at Grünenthal GmbH in Aachen, Germany. Before taking on this position, Michael was Team Lead and Account Manager at Systec&Services GmbH, contracting for Pharma Customers and MES and Track&Trace System suppliers. He is very experienced in project and program management in global multi-site rollouts. Along that, he gathered expert knowledge in the fields of Pharmaceutical Production and Packaging Process as well as Pharmaceutical Supply Chain and T&T regulations.
Michael holds a Diploma in Information Engineering and Management, University Karlsruhe (KIT).
The Grünenthal Group is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation.
Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a €2 billion company.
We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.
Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in 32 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2016, Grünenthal achieved revenues of approx. € 1.4 bn.
Marco Glauner is co-founder and managing partner of prime4services, working as an acknowledged expert and senior consultant for pharmaceutical manufacturing topics with numerous players in the pharmaceutical arena. Over the past 20 years, he built up his expertise through various positions at supplier and service companies, always focussing on life science industries with his work.
Marco’s key expertise is in areas of MES and T&T systems, bundled with his know-how on business process analysis, system landscape design & harmonisation, deployment & operations methodologies, project/program management and system validation.
World class through Efficiency & Transparency
Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.
We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.
Use our skills and rich experience for your benefit!
Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.
Technical Director/Founder of the OPEN-Serialization Communication Standard (SCS) Working Group.
BSs in Chemical and Material Engineering, MS in Solid State Physics from Univ. of Maryland.
As TQM Facilitator and Process Action Team Leader of over 28 years, Mr. Gifford led and designed MES, operations management, and supply chain system projects to part of planned intelligent manufacturing transformation across 12 industries and 80 plants. As international recognized chair and author of intelligent manufacturing standards for over 25 years such as International Society Automation, OPC Foundation, OPEN-SCS WG, Open Application Group, Supply Chain Council and MESA International. Authored, applied and taught many of today’s applied intelligent manufacturing operations standards (ISA-88, ISA-95, OAGIS, SCOR, others).
An internationally recognized teacher and author of 5 books, over 50 papers, and 20 courses on combining continuous improvement practices with intelligent manufacturing operations management systems. ISA’s Best Standard Book of Year 2011, 2013.
Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products. The open standard and work products are focused on the standardization of data exchanges for Healthcare packaging serialization and the aggregations between a Healthcare provider’s enterprise serialization management function and their product packaging lines. This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management). The scope of the 2016/17 work products focuses on data exchanges for 6 proposed use cases in two data exchange categories: 1. Mandatory Services and 2. Support Services which are addressed in 6 common Packaging Line Serialization System Configurations.
Barak Perelman is the CEO and Co-Founder of Indegy, an industrial cybersecurity startup building a comprehensive security and governance platform to protect industrial networks and critical infrastructures. Before founding Indegy, Perelman led several multimillion dollar cybersecurity projects at the Israeli Defense Force and received commendation for his service and achievements. He is a graduate of the elite Talpiot military academy and has over 15 years of hands-on experience in cybersecurity and protection of critical infrastructures. Perelman holds a B.Sc. in computer science, physics and math, and an MBA from the Tel Aviv University.
Solution Study
The Vulnerability of Cloud, X 4.0, Connected Systems - Security issues to be considered: System and network resilience against internal and external attacks.
In the ever more connected pharmaceutical industry, global manufacturing and distribution companies need to be aware of an expanding range of security demands and threats. With a broad spectrum of products and manufacturing facilities in a variety of countries, it simply becomes mandatory to protect a company not only against operational incidents leading to unplanned downtime and increased manufacturing costs. A company’s security strategy needs to address external and internal threats targeting the company's intellectual property. This Solution Study not only raises awareness but will make a first approach to answer the following questions:
Indegy protects industrial control networks against operational disruptions caused by Cyber Threats, Malicious Insiders and Human Error, and ensures operational safety, continuity and reliability, by providing real-time visibility and control. The Indegy platform delivers unparalleled visibility into the critical control-plane of ICS networks to identify threats that put industrial automation controllers (PLCs, RTUs, DCS) and the processes they manage at risk. It maintains a comprehensive asset inventory and captures all changes to these assets, whether performed by malware or human, and whether authorized or not.
PQE is a complete quality solution provider operating in the life science industry since 1998. Thanks to the 16 offices worldwide from Japan to USA, we can rapidly support you anywhere you require in the following areas: Data Integrity Assurance & Computer System Validation, Qualification & Engineering, Compliance, Regulatory Affairs and 3rd Party Audits.
Our unique capabilities enable companies to achieve and maintain compliance with FDA, EMA and other international, regional and local regulatory agencies.
We will support you to find the most sustainable way to develop practical and tailored plans that align global quality capabilities with your business strategy.
Project & Quality Manager with 9 years’ experience in the healthcare industry. Damien is an expert in:
EXPERIENCE – CAREER HISTORY
April 2015 Senior Consultant Halfmann Goetsch Partner AG, Basel (Switzerland)
Providing consulting to the pharmaceutical industry with focus on
2014- 2015 Project Manager & CSV Leader CVO-Europe, Basel (Switzerland)
Providing IT consultancy for healthcare industry companies in Switzerland:
2013 IT Program Leader Novartis Biopharmaceutical Operations (France)
Developing a 5 years strategy for Information Technology unit to strengthen high-valua-ble computer systems onsite (1 year - 1.5 M€).
Building a new IT architecture with all local stakeholders (automation, IT, business units)
2012 Senior IT Project Manager Novartis Biopharmaceutical Operations (France)
2011 IT Application Manager / Business Analyst Novartis Biopharmaceutical Operations (France) Supporting Quality, Engineering, Manufacturing Units with:
Assisting global infrastructure remediation program:
2010 Service Infrastructure Manager / Project Manager Novartis Biopharmaceutical Operations (France)
2007- 2009 IT Project Manager / Business Analyst Novartis Pharmaceutical Operations (France)
Solution Study
Roll-out of serialization program in a pharma company in various sites and locations - an experience report
HGP is one of the leading business consultancies specializing in the healthcare industry. Based in Switzerland, with subsidiaries in Germany and Singapore, the company has experienced substantial growth since it was founded in 2008.
Our expertise lies in the efficient use of technology, streamlined processes and standardization that is required in today’s healthcare industry which researches, produces and markets in global networks. HGP provides expert consultancy for GMP, quality, risk & compliance management, successful implementation of LEAN, paperless manufacturing and MES and the passing of audits and inspections.
Our clients are SMEs, global corporations, manufacturers and suppliers in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices, manufacturers of packaging machinery, processing equipment and also software providers for the pharmaceutical industry.
Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out even global projects with the necessary expertise and presence.
Enterprise System Partners (ESP) is a leading global consulting and project engineering company – supporting manufacturing IT solutions for the life science industry since 2003.
We offer specialist support and consulting services exclusively for manufacturing and supply chain operations in biotechnology, pharmaceutical and medical devices, with core focus on Manufacturing Execution Systems (MES) and serialization.
We design, implement and integrate Manufacturing Execution Systems (MES). Our key people have a collective knowledge of the entire systems landscape including Enterprise Resource Planning (ERP), Process Automation and Laboratory Systems. In short, we understand how it all fits together and can deliver system projects for individual systems or an integrated solution across the systems landscape.
Our primary focus is delivering value to our clients by the selection and implementation of appropriate systems to achieve their goals, such as, increasing efficiency & flexibility, reducing the burden of compliance & meeting regulations (e.g. serialisation). We have earned the respect of many of the keys vendors, yet remain vendor independent, so we can represent your needs exclusively. We can operate at both site and corporate levels to achieve the best approach. We will leverage experience and cost from past projects both within your corporation and from our expertise gained throughout our industry.
Adents is a software specialist of unique product identification and traceability helping pharmaceutical companies and contract manufacturers to adapt to market changes and comply with regulations on drug traceability. Adents Pharma Suite utilizes user friendly, standardized software compatible with both information systems (ERP, MES) and existing production and packaging equipment. Easily upgradable, the software is designed to address both current and emerging regulations to help pharma companies remain in compliance long term.
Founded in 2007, Adents operates in Europe, Canada, and in the United States.
Over 25 years’ experience in Pharmaceuticals, held various positions and roles. Actively involved in many reorganizations, integrations and separation after takeovers and business split. Respected Expert in MOMS, Operations and Logistics and able to translate the requirements of the Business to practical cost effective, innovative Automation and IT solutions. Active in various User Groups like Senior Oversight Group Coding and Serialization of EFPIA and presenter/panel member at many congresses.
Case Study
Update on the Open-SCS Initiative
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries. Abbott Nutrition is a division of Abbott, the global, broad-based health care company. Health care professionals and their patients trust us to provide cutting-edge nutrition products that meet changing nutrition needs.
Jyrki Syväri, Pharmacist and Chemist, made his PhD Theses in Pharmaceutical Chemistry and his Diploma in Chemistry in Analytical Chemistry. He joined Boehringer Ingelheim to become a Project Manager in Operations. He was responsible for the world-wide launches of new products, such as Metalyse and Spiriva. Thereafter he was heading a group called “Launch and Special Supplies”. In this function he was responsible for setting up supply chains for Boehringer Ingelheim’s new products. New Supply Chain paradigms and concepts fell also under his responsibility. In this context he became the world-wide program leader for BI’s Product Safety & Security project that centres around serialisation. Additionally, Jyrki is leading the global initiative Supply Chain Integrity which takes a broader view on supply chain security, transparency and Risk Management.
World Café
Compliance Requirements of Serialization, Track & Trace
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Still headquartered in Ingelheim, it operates globally with 146 affiliates and more than 47,700 employees. The company's key assets of interest are: respiratory diseases, metabolism, immunology, oncology and diseases of the central nervous system. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. Boehringer Ingelheim is a full member of the European Federation of Pharmaceutical Industries and Associations EFPIA.
Ravi Kalyanaraman, Ph.D., is an Associate Director at Bristol-Myers Squibb Company in the Global Analytical Technology group with Global Manufacturing and Supply. He received his Ph.D. from the University of Idaho in 1995 and did his post-doctoral work at the University of Puerto Rico. He served as a faculty member in the department of chemistry at Bemidji State University in Minnesota from 1996 to 2001. He has been with Bristol-Myers Squibb since 2002. His laboratory work in the past with Bristol-Myers Squibb was primarily in developing and validating chromatographic methods for Quality control laboratories. In the last seven years he has focused on developing new and novel techniques to detect pharmaceutical counterfeits and raw material identification using vibrational spectroscopic techniques, such as Raman, mid-, and near-infrared (NIR). Currently, he leads a team of analytical scientists that are involved in the forensic and manufacturing investigation for products received from product complaints, corporate security and also from various manufacturing sites including third party manufacturing. Also, his laboratory is currently developing new and novel Raman spectral fingerprint techniques for biologics drugs which can be used to screen counterfeit biologics.
Case Study
The Missing Link: Chemical Detection of Counterfeit Drugs
Bristol-Myers Squibb (BMS) is an American pharmaceutical company, headquartered in New York City. Bristol-Myers Squibb manufactures prescription pharmaceuticals in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis and psychiatric disorders.
BMS' primary R&D sites are located in Lawrence Township (formerly Squibb, near Princeton) and Wallingford, Connecticut (formerly Bristol-Myers), with other sites in Hopewell and New Brunswick, New Jersey, and in Braine-l'Alleud, Belgium, Tokyo, Japan and Bangalore, India.
Work Experience:
Strong Production Background. 9 years (5 full time and 4 part time while attending University) as a Production Operator in ISO 9001 regulated Manufacturing Plant – Lisk Ireland Manufacturing Ltd (Non Pharmaceutical).
2005 – 2007 – Abbott Ireland Diagnostics Division as a Diagnostic Technologist and was Promoted to the Position of Process Specialist
2007 – present – Astellas Ireland Co. Ltd.; Kerry Plant. Process Technologist in the Packaging Department. Since 2015 I have been the Validation Lead for our Global Serialisation Roll Out Project
Education:
2001 – 2005 I Studied Chemistry & Biochemistry as a Mature Student in the National University of Ireland - Galway – 1st Class honors Degree in Biochemistry
Case Study
Introduction of Serialisation in Astellas Ireland Co. Ltd, Kerry Plant – The Falls Along the way and the Getting Back Up Stronger!
Astellas Pharma Inc. is a Japanese pharmaceutical company, formed on 1 April 2005 from the merger of Yamanouchi Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd. Astellas' franchise areas are urology, immunology (transplantation), dermatology, cardiology, and infectious disease. Priority areas for R&D are infectious diseases, diabetes, gastrointestinal diseases, oncology, and diseases of the central nervous system. Worldwide the company employs about 17,000 people.
Hariom Upadhyay is passionate about drug safety. Post-graduate in Pharmacy with more than 7 years of experience in different domains of Pharmacovigilance gives him a unique ability to drive process improvement initiatives leading to sustained compliance with global regulatory requirements.
Icebreaker
Serialized authentication of medicines by Feb 2019
Case Study
How to cope with permanent and quick changes in the regulatory landscape: Drug Safety Perspective
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland and is one of the largest pharma companies of the world. The businesses of Novartis are divided into three operating divisions: Pharmaceuticals, Alcon (eye care) and Sandoz.
Since 01/2014 Business Development Manager at ACS PharmaProtect GmbH, Berlin
01/2012-12/2013 Project Manager at Boehringer-Ingelheim
Case Study
Roadmap for companies to join the National Medicines Verification System in Germany
February 2010-today General Manager at Jaba Recordati
December 2007-December 2009 Commercial Director at Jaba Recordati
March 2004-2007 Sales director at Menarini
January 2003-March 2004 Sales Director at Almirall Portugal
Januar 2003 – März 2004
January 1998-January 2003 Sales Manager at Sanofi-Synthelabo
Case Study
Track&trace and serialization in the pharmaceutical industry: Is it a “Fashion” or a “Critical” approach?
Jaba Recordati S.A. develops and delivers pharmaceutical products. It offers drugs in various therapeutic areas that include hypertension, dyslipidaemia, urology, and musculo-skeletal. The company also provides over-the-counter and medical devices; products for the management of plaque, gingivitis treatment, prevention of periodontitis, thrush of the mouth, and solution for the user dentures; ENT products; Dolomate 200, a solution for headaches, muscle aches, menstrual pain, and fever; Frenalgil Gel, a solution for treatment of inflammation post - traumatic tendons, ligaments, muscles, and joints; Procto-Glyvenol, a solution for treatment of hemorrhoids; natural salt; and generic drugs....
After diploma degree in economy-engineering logistics starting as project manager for logistics for Carl Zeiss Meditec.
Afterwards working as process consultant for production planning for half a year, before entering the serialization world.
Since 2013 working as global project manager track&trace for Fresnius Kabi. Therefore I am responsible for supporting roll-outs worldwide due to processes and technical issues for procution, IT and warehouse topics as well as defining Fresenius standards dues to serialization.
World Café
Serialization: From project to operational phase
What to consider when starting the serialization projects (different legal requirements/timelines, different company standards vs. one global serialization standard)
Main issues coming up during project implementation and measurements to avoid them in roll-out.
How to handle cutover from project to operational phase (what to consider, what and how to prepare, avoiding high negative OEE-impacts, handing of software updates, responsibilities in operative work, handling of changes in requirements, test systems)
Fresenius SE & Co. KGaA is a European diversified health care company based in Bad Homburg, Germany. The Fresenius Group provides products and services for dialysis, hospitals as well as inpatient and outpatient medical care. In addition, the company focuses on hospital management as well as on engineering and services for medical centers and other health care facilities.
June 2013- today Serialisation Project Implementation Coordinator at GlaxoSmithKline Poland
2001-today QA Coordinator – Validation at GlaxoSmithKline
Case Study
Required Changes in Pharma Company due to Serialization Based on GSK Poznan experiences:
GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered in Brentford, London. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, GSK is one of the world's largest pharmaceutical company.
Uriel Moeller is working on the ALPhA-Project as a research assistant since 2014. He is a PhD student at Osnabrück University in cooperation with PUCRS University in Porto Alegre, Brazil, since 2013. From 2007-2012 he was a law student and obtained his erstes Staatsexamen in Hamburg, while spending two semesters from 2009-2010 at University of Edinburgh, Scotland.
Case Study
Pharmaceutical Crime in Germany and Europe
+30 years’ experience in Leadership, consulting and Project Management in various industries, mainly pharmaceutical and internationally within Sourcing, Supply Chain and Production. Since 2013 focus has been serialisation as consultant for various pharmaceutical companies and lately as Head of Serialisation Programme for LEO Pharma, an international leader within dermatology
Case Study
Serialisation strategy seen from a midsize Pharma company
Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company.
LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally. To realise their vision of becoming the preferred dermatology care partner improving people’s lives around the world, they are expanding into new regions and markets, reaching more patients and societies with drugs and therapies that address unmet medical needs.
LEO Pharma has its own sales forces in 61 countries and employs around 5,000 employees worldwide. The company is headquartered in Denmark and is wholly owned by the LEO Foundation.
Project & Quality Manager with 9 years’ experience in the healthcare industry. Damien is an expert in:
EXPERIENCE – CAREER HISTORY
April 2015 Senior Consultant Halfmann Goetsch Partner AG, Basel (Switzerland)
Providing consulting to the pharmaceutical industry with focus on
2014- 2015 Project Manager & CSV Leader CVO-Europe, Basel (Switzerland)
Providing IT consultancy for healthcare industry companies in Switzerland:
2013 IT Program Leader Novartis Biopharmaceutical Operations (France)
Developing a 5 years strategy for Information Technology unit to strengthen high-valua-ble computer systems onsite (1 year - 1.5 M€).
Building a new IT architecture with all local stakeholders (automation, IT, business units)
2012 Senior IT Project Manager Novartis Biopharmaceutical Operations (France)
2011 IT Application Manager / Business Analyst Novartis Biopharmaceutical Operations (France) Supporting Quality, Engineering, Manufacturing Units with:
Assisting global infrastructure remediation program:
2010 Service Infrastructure Manager / Project Manager Novartis Biopharmaceutical Operations (France)
2007- 2009 IT Project Manager / Business Analyst Novartis Pharmaceutical Operations (France)
Solution Study
Roll-out of serialization program in a pharma company in various sites and locations - an experience report
HGP is one of the leading business consultancies specializing in the healthcare industry. Based in Switzerland, with subsidiaries in Germany and Singapore, the company has experienced substantial growth since it was founded in 2008.
Our expertise lies in the efficient use of technology, streamlined processes and standardization that is required in today’s healthcare industry which researches, produces and markets in global networks. HGP provides expert consultancy for GMP, quality, risk & compliance management, successful implementation of LEAN, paperless manufacturing and MES and the passing of audits and inspections.
Our clients are SMEs, global corporations, manufacturers and suppliers in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices, manufacturers of packaging machinery, processing equipment and also software providers for the pharmaceutical industry.
Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out even global projects with the necessary expertise and presence.
April 2014-today IT Director at DSM Sinochem Pharmaceuticals
January 2011-April 2014 Business Information Manager at DSM Sinochem Pharmaceuticals
October 2009-January 2012 Business Information Manager at DSM Anti-Infectives
September 2006-September 2009 SAP System Validation and cGMP Expert at DSM Anti-Infectives
February 2001-August 2006 Business Systems Manager at DSM Anti-Infectives
1998-2001 ICT Project Manager at DSM
Case Study
DSM Sinochem: 140 years of innovation, DSP’s journey towards serialization
Royal DSM N.V. is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext.
Solution Study
Successfully Managing Master Data and Ensuring Data Integrity
With innovative and superior quality products and services, ACG Worldwide has been serving the global pharmaceutical industry with innovative processing, manufacturing and packaging solutions.
ACG Inspection, a member of ACG Worldwide provides high-tech camera inspection systems and global regulations compliant Track and Trace systems for cartons and bottles. The innovative machine vision systems by ACG Inspection are designed to inspect quality aspects in both solid and liquid dosage forms.
www.acg-world.com
With almost 30 years of experience in the pharma packaging industry and based on his diploma in Applied Physics, Hendrik took several positions in this specialized industry. Starting from the R&D of opto-electronic systems, project management and international sales, he also covered the position of the Managing Director and CEO of the Laetus Group before he joined Antares Vision Srl. In his current position, he is building up a new organization for sales, project management and services for the German speaking areas. His expertise is in the field of serialization / Track&Trace for all kinds of applications but also in the warehouse management of serialized goods.
Solution Study
How to build an Integrated Company Infrastructure for serialization and aggregation to cope with current and future regulations
Antares Vision (AV) is a privately owned Italian company with its headquarter in Brescia. Since the beginning, Antares Vision is focussed onto the serialization and Track&Trace requirements of the pharmaceutical and food industry, serving more than 300 customers on all continents in 40+ countries. With the experience of more than 750 validated installations in the world, Antares Vision can claim to be the market leader in supplying solutions to the pharma industry for complying with current and future Track&Trace requirements.
Solution Study
T&T is in place – and now comes the hard part - actually operating efficiently and understanding the true impact of ownership
Challenge your Peers
Industry 4.0 and Track & Trace
World class through Efficiency & Transparency
Integrated processes, from shop to top floor, from planning to distribution, is a strategic objective but yet remains a major challenge for most companies in the regulated industry. Full benefits cannot be achieved by just installing alone a system for process control. To reach that full potential – situational analysis, specifically tailored concepts and efficient implementation strategies must be developed in close alignment with the company’s organisation, associated culture and established processes.
We at prime4services actively engage and support your organisation to realise the maximum use and optimal potential across all processes and company levels. With our agile and innovative approach we ensure an optimal and efficient implementation of projects.
Use our skills and rich experience for your benefit!
Our methodology-based approach brings together processes, technologies and people. This holistic approach leads to a solution that makes optimal use of both existing and new systems / resources – neutral and vendor-independent.
Michael Ventura, Director, Industry Solutions, TraceLink - Michael joins TraceLink following a 30-year career as the former serialisation and security lead for GlaxoSmithKline (GSK) in the Americas, including 8 years as an active GS1 Global and GS1 US member, where he currently serves as an elected member of the GS1 US Executive Leadership Team and co-chair of the traceability team. While at GSK, he led the company’s patient safety and fraud prevention efforts and provided guidance on implementing effective solutions for EMR development, SMS patient authentication, point-of-dispense authentication, and full traceability pilots. In his new role, Michael will lead strategic discussions with pharmaceutical companies that face significant infrastructure and operational challenges in meeting global track and trace compliance deadlines, and provide practical insight to manufacturers that are working to put successful serialisation strategies in place over the next two to three years.
World Café
Setting the Scenes for Efficient Serialization Strategies: How to Organize Conception, Planning and Implementation?
TraceLink is the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace. Leading businesses, including 16 of the top-20 global pharmaceutical companies, trust the TraceLink Life Sciences Cloud to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to comply to track and trace regulatory requirements anywhere in the world, and improve performance across global supply, manufacturing and distribution operations. Winner of numerous industry awards including the Amazon AWS Global Start-Up Challenge Grand Prize and the Edison Award for Innovation in Health Management, the TraceLink Life Sciences Cloud is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost.
acing the Challenges, How Using Standards For Serialization Can Bring Real Business Benefits
Chemist by education. (PhD in analytical chemistry and MBA)
More than 15 years of experience in Pharma industry (from TEVA to greenfield venture; from R&D to QC)
Since 2014 with Tradeticity.
Solution Study
An update and perspective of Quality in a shifting and heterogeneous regulatory landscape, and its impact on pharmaceutical serialization
Tradeticity provides cost-effective serialisation solutions, designed from the ground-up with quality compliance in mind. Our system is in accordance with GAMP 5, and is capable of end-to-end serialisation (to be compliant with the EU Directive 2011/62/EU) and full, item-level Track and Trace. Whilst the final solution we provide is bespoke for our client’s needs, the core system is standard, therefore easy to document and maintain compliance.
Our team was assembled solely for this purpose, and includes IT specialists, and pharmaceutical compliance specialists who have many years’ experience at the biggest software and pharmaceutical companies in the World, giving us a deep understanding of the challenges faced.
We are proud to be a Croatian company, giving easy access to pharmaceutical manufacture in South-East Europe, but equally we have an International presence, with offices in US, Brazil and UK.
Since 2014, Reinhold van Ackeren is Head of Marketing and Product Management at METTLER TOLEDO PCE.
Before, Reinhold covered various Management roles in the consumer industry, in the telecommunications and IT sector. In addition, Reinhold worked as a Management Consultant on Business Development and Marketing projects.
Case Study
Sanofi Serialization program
Detlef Richter has more than 20 years’ experience in the chemical and pharmaceutical industries. His professional background is chemical engineering with university diploma. After 10 years in consulting and managerial position in consulting companies Detlef joined STADA Arzneimittel AG’s Corporate IT. Within the scope of his functions, he has been in charge of various national and international projects, implementing business process applications serving the whole supply chain as ERP-, Advanced-Planning-, LIMS- and MES-Systems amongst others. As Director of IT Consulting & Applications Logistics he is group wide responsible for the business applications along the supply chain involving purchasing, production, warehouse, quality management, sales and planning. Inside Detlef’s current position he is the IT-Project-Lead of STADA’s Global-Serialization-Infrastructure. He is strongly committed to making the falsified medicine directive a cost efficient and beneficial solution for the involved pharmaceutical companies.
Challenge your Peers
What shall we do with this billions of data records captured within serialization?
Martin Fusek, Global Head Testing Service Novartis Business Service, HEXAL AG / Germany
After studying electrical engineering Martin Fuseks career started as a project engineer and later as a project manager and quality manager for MES at Propack Data GmbH. In 2005, he joined Ratiopharm and helped as IT Manager in the Merckle Biotec GmbH mainly to introduce an EBR solution. In 2007 he changed the company and joined Hexal AG as an MES project manager, before he assumed in 2008 the position of Head TechOps IT Germany. In 2012 he took over the role as Global Head IT QA CC and led the global Competence Center who assure the operation of the global IT systems for the global QA department. With the announcement of Novartis Business Service in 2015 he took over the lead of a centralized IT application testing center of excellence for GxP- and non-GxP Testing.
Challenge your Peers
Is your T&T Validation approach compliant, risk based and lean?
October 2014-today Manager Engineering Projects at R-Pharm Germany GmbH
January 2012-September 2014 Project Engineer / Manager at Pfizer Manufacturing Deutschland GmbH
January 2013-March 2014 Project Manager at Pfizer
January 2010-December 2011 Management Trainee - Technical Operations & Logistics at Pfizer
2007-2010 Engineer Technical Support at Pfizer
Case Study
Serialization & Aggregation as a CMO
Ulrike Kreysa is responsible for the Healthcare sector at the GS1 Global Office in Brussels and works with her local colleagues in 112 countries across the world to develop and implement GS1 standards in the healthcare industry.
Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, group purchasing organizations, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations.
GS1 Healthcare has the mission to lead the Healthcare sector to the successful development and implementation of global standards. Worldwide patient safety and supply chain efficiencies will be enhanced globally through standards for AIDC (Automatic Identification and Data Capture), global data synchronisation and traceability.
Ulrike works regularly with decision makers from leading companies and regulatory bodies to drive harmonisation of standards in the implementation across the world.
Case Study
Track & Trace – for safer and better Healthcare
When everyone uses the same standards, it’s easier to get things done. Just imagine if we didn’t have a standard way to measure time or distance.
It’s the same with our supply chain standards. They define ways to store and transfer data so organisations can exchange information smoothly.
Supply chain standards save time and money by reducing administration and slashing paperwork. Largely unseen, yet tremendously important, GS1 standards ensure key processes run smoothly in some of the world’s biggest industries. For instance:
David Harty has guided the introduction of serialization systems at a variety of pharmaceutical manufacturers and distributors, chemical processing facilities for source batch genealogy, and automotive and consumer products companies. In doing so, he gained a comprehensive understanding of precisely what is involved in implementing serialization programs and systems, including requirements for governance and proper usage of architectural concepts and models to insure data integrity and performance.
Prior to joining Adents, Mr. Harty held various software development, product management, and program management positions, including Chief Architect of Industry Solutions at Siemens IT/Atos, Chief Architect of Intelligent Supply Chain at VeriSign, and Chief Technology Officer of Acsis. He is also the inventor of DataLink™, a device and protocol independent software product used globally by Fortune 100 companies in mission critical manufacturing and warehouse applications.
Technology Café
Shaking up preconceived ideas on serialization technology
Adents is a software specialist of unique product identification and traceability helping pharmaceutical companies and contract manufacturers to adapt to market changes and comply with regulations on drug traceability. Adents Pharma Suite utilizes user friendly, standardized software compatible with both information systems (ERP, MES) and existing production and packaging equipment. Easily upgradable, the software is designed to address both current and emerging regulations to help pharma companies remain in compliance long term.
Founded in 2007, Adents operates in Europe, Canada, and in the United States.
Jean-Marie is a visionary leader with more than 20 years of experience dedicated to building and delivering technology solutions that protect patients, ensure product integrity and improve business performance. Currently playing a pivotal role in TraceLink’s global expansion, Jean Marie is leading the EMEA operations to build collaborative relationships with Pharmaceutical companies and help improve traceability of medicines across the Life Sciences supply chain. Jean Marie has held several successful leadership roles spanning through 15 years of serving companies in the Life Sciences industry. At Abbott Diagnostics, he led development of enterprise solutions to help improve business processes. Before joining Abbott Diagnostics, he helped Phase Forward become a market leader in Europe, holding senior sales roles prior to and following Phase Forwards acquisition by Oracle. Jean Marie started in Life Sciences at Aster Cephac where he focused on contract research. Originally a native of France, he holds a master’s degree in business from the Center d’Etudes Supérieures de Management International (CESMI, ISG group).
TraceLink is the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace. Leading businesses, including 16 of the top-20 global pharmaceutical companies, trust the TraceLink Life Sciences Cloud to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to comply to track and trace regulatory requirements anywhere in the world, and improve performance across global supply, manufacturing and distribution operations. Winner of numerous industry awards including the Amazon AWS Global Start-Up Challenge Grand Prize and the Edison Award for Innovation in Health Management, the TraceLink Life Sciences Cloud is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost.
Ann Schaefer is Associate Director - Supply Chain Management for Acorda Therapeutics in Ardsley, New York.
As Associate Director, Ann is responsible for the Commercial Supply Chain working with Acorda’s Contract Manufactures, Packagers and Third Party Logistics partners. In addition, Ann is Program Lead for the Drug Supply Chain Security Act (DSCSA) Implementation Team.
She has been with Acorda for seven years and has over 25 years of experience working in production and inventory management, operations management and quality assurance for FDA regulated companies.
Ann holds a BA degree from Alvernia University and has done graduate work at the State University of New York at Buffalo and The Pennsylvania State University; in addition Ann is a certified Exemplar Global auditor for Quality Management Systems and is a member of the Tappan Zee Chapter of The Society for Operations Management (APICS) and past Board of Directors member.
Challenge your Peers
At what stage is your Serialization Implementation Program Team?
Acorda Therapeutics is a biotechnology company based in Ardsley, New York, USA. Acorda’s mission is to develop therapies that restore function and improve the lives of people with neurological disorders.
In 2014, Frank Thönnissen joined Videojet Technologies GmbH. In his position as Salesmanager Pharma DACH he is in charge of Business Development Pharma/OEM in region Germany/Austria/Switzerland.
His expertise is in the field of coding/serialization for all kinds of applications in the pharma/packaging industry.
Before Frank performed various Sales and Management roles in the Document-Management- & IT-Solutions industry. In addition, Frank worked as a Management Consultant on Business Development and Marketing projects.
Challenge your Peers
Underestimated key criteria for high-quality coding to comply with DSCSA, UDI and FMD requirements
Videojet Technologies is a world leader in industrial coding and marking solutions with a dedicated global pharmaceutical team supporting organizations and supply chain partners with solutions, certifications and fast, reliable service. A product portfolio including thermal inkjet, laser marking, continuous inkjet and labeling provides consistent, high-quality serialization and traceability codes, helping the pharmaceutical and medical device industries safeguard their products against counterfeiting and protect consumer safety. With a wide range of technologies addressing virtually any application, Videojet is the expert in realizing the specific requirements of a wide range of healthcare applications.
With decades of knowledge, Videojet Technologies’ expertise in industry standards and global regulations makes them the right partner for understanding complex coding needs. Videojet solutions code 10 billion products a day worldwide, playing a vital and responsible role in the world. With over 4,000 associates serving 135 countries, Videojet has the capability to provide local service through global resources.
Technical Director/Founder of the OPEN-Serialization Communication Standard (SCS) Working Group.
BSs in Chemical and Material Engineering, MS in Solid State Physics from Univ. of Maryland.
As TQM Facilitator and Process Action Team Leader of over 28 years, Mr. Gifford led and designed MES, operations management, and supply chain system projects to part of planned intelligent manufacturing transformation across 12 industries and 80 plants. As international recognized chair and author of intelligent manufacturing standards for over 25 years such as International Society Automation, OPC Foundation, OPEN-SCS WG, Open Application Group, Supply Chain Council and MESA International. Authored, applied and taught many of today’s applied intelligent manufacturing operations standards (ISA-88, ISA-95, OAGIS, SCOR, others).
An internationally recognized teacher and author of 5 books, over 50 papers, and 20 courses on combining continuous improvement practices with intelligent manufacturing operations management systems. ISA’s Best Standard Book of Year 2011, 2013.
Icebreaker
Open Serialization Communication Standard
Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products. The open standard and work products are focused on the standardization of data exchanges for Healthcare packaging serialization and the aggregations between a Healthcare provider’s enterprise serialization management function and their product packaging lines. This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management). The scope of the 2016/17 work products focuses on data exchanges for 6 proposed use cases in two data exchange categories: 1. Mandatory Services and 2. Support Services which are addressed in 6 common Packaging Line Serialization System Configurations.
Regulatory Café
Challenges of the United Europe – implementation status in the different member states
May 2009 - present
Technical Projectmanagement, Vifor Pharma, Switzerland
June 2000 – April 2009
Head Clinical Manufacturing,
Schering-Plough, Werthenstein Chemie AG, CH – Schachen/LU
October 1997 – May2000
Project Leader, Galenical Development Department,
Siegfried CMS AG, CH – Zofingen/AG
August 1993 – September 1997
Laboratory Head, Research and Development,
LTS LOHMANN Therapie-Systeme GmbH, D – Andernach
September 1987 – July 199
Research assistant, Department of Pharmaceutics and Bio pharmaceutics, Christian Albrecht University of Kiel (Germany)
Solution Study
Roll-out of serialization program in a pharma company in various sites and locations - an experience report
Case Study
Opportunities for serialization: an outlook into the future
At Tjoapack, we like to employ people with a 'can-do' mentality. If a client contacts us with a problem or question, we always do our best to find a solution, either by ourselves or in collaboration with partners. In addition, we don't just wait for clients to approach us with their challenges or questions: we are always searching for more ideas to improve patient safety, and the safety of the products we supply. For example, we have been working on the introduction of serialised barcoding since 2007, even though this will only become a legal requirement in 2019.’ Bas de Gooijer studied Sociology and Business Management. He has more than 15 years of experience in the field of pharmaceutical packaging, and has worked in both the Netherlands and abroad.
