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.

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.

Solution Study
An update and perspective of Quality in a shifting and heterogeneous regulatory landscape, and its impact on pharmaceutical serialization

• Earlier this year, the EU published 2016/161 which mandates serialization of pharmaceutical products for the EU by February 2019, also the FDA published their DSCSA guidance plans for 2016
• In addition, the FDA issued a new draft guidance document “Data Integrity and Compliance With CGMP Guidance for Industry - DRAFT GUIDANCE” this year, which scrutinizes the description and validity of Cloud-based solutions in CGMP environments
• These documents alone have generated many questions around Quality Compliant Serialization for our client-base, especially in heterogeneous manufacturing environments, and for multiple export markets
• These regulations, changes to them, and many others complicate the planning and Global manufacture of pharmaceutical products, owing to the diversity of regulations which must be adhered to regarding serialization and other anti-counterfeit strategies.
• From these, we see that any software solution for serialization, aside of its expected functionality, must:
  • Be Compliance-ready for regulatory requirements from any agency or government
  • Be Configurable for any work order, production, packaging or other manufacturing process
  • Offer validation tools for work flows
  • Have Clear audit trail to smooth audits
  • Allow integration with your CMO’s processes

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.

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.

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.

Challenge your Peers
Underestimated key criteria for high-quality coding to comply with DSCSA, UDI and FMD requirements

• How to ensure high-quality coding of alphanumeric & datamatrix codes?
• How to verify the appropriateness of your existing cartonboard?
• How the right combination of cartonboard quality & ink type impacts the coding result (grading) significantly?
• Do you limit your max. production line speed just because of actual cartonboard quality?

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.

Industry benchmark

Smart Packaging enabling the Internet of Things: Consumer - Product Interaction Through NFC Technology

• Basic and Future requirements in packaging technology
• Industry Benchmark: What are customer and industry needs?
• How to set up an ecosystem to drive technological growth and progress
• What’s the actual technology you are using and how will it move the packaging world

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.

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.

Case Study

It always starts with one plant – What can big companies learn from SMEs?

• Counting the Business Case and drafting a project roadmap
• Developing the environment: scaling not only the solution but also IT
• Implications for the overall strategy: Proceed according to limited resources
• Traps and pitfalls

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.

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.

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.

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.

IT Challenges Café

How to handle individual process requirements in a standardized TT solution interface environment?

• Dealing with different roles of one company: What are requirements down the supply chain and up to the customer?
• How to set up the internal organization to define supplier requirements, include internal IT & plants and meet customer needs?
• How to organize technical interface adjustments to ensure sufficient data exchange along the entire supply chain?
• Individual standardization: How to handle the multitude of variants resulting from ongoing adjustment?
• How to achieve increasing efficiency in process and performance from roll-out to roll-out?

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.

Keynote

GO LIVE Serialization - 5Ws Stress test for your company: Is your orgnization fit for mandatory Serialization?

• What will happen? - EU Falsified Medicines Directive, Company Drug Supply Chain Security Act…..: Implications of near future regulatory coming into effect.
• Who is involved?
• Industry sectors, vendors & service suppliers, whosesalers, distributors – Considerations along the supply chain
• Internally determining and defining responsibilites for aligning project manpower
• Where does it take place? – Identifying organizational weak spots for determining target areas and need for change.
• When does it take place? - Setting up a timeline to meet regulatory requirement within given deadlines.
• Why does that happen? – Raising awareness and receiving support to create a compliant on site environment.

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.

Solution Study
Roll-out of serialization program in a pharma company in various sites and locations - an experience report

• Define the serialization IT architecture in 4 levels
• Developing a validation concept for the global serialisation architecture and its components
• Deployment of an integrated solution for serialization of pharmaceutical products
• Sustain IT operations model for serialization

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.

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:

• How to overcome the inability to track and confirm maintenance work performed by third-party contractors?
• How to avoid flawed maintenance leading to unplanned downtime?
• How to solve difficulties identifying the source of the problem due to lack of event logs and forensic data?
• How to meet validation process requirements for manufacturing to guarantee zero changes in DCS systems?

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.