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.

Technical Overview for the Approved OPEN-SCS Packaging Serialization Specification 1.0

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.

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 Packaging Serialization Specification 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 Packaging Serialization Specification 2.0.

The Countdown is running: Updates and Must-Knows about the EU-Hub On-boarding Process.

Tobias Beer has over 8 years’ experience in Pharmaceuticals and held various positions and roles. In his previous positions at Boehringer Ingelheim and Germany’s National Medicines Verification Organisation (ACS/securPharm) Tobias was responsible for development of sustainable business areas and procedures compliancy to statutory requirements and the implementation of Directive 2011/62/EU (Falsified Medicines Directive). In his current position as Head of Commercial and Partner Management at the European Medicines Verification Organisation (EMVO) in Brussels Tobias and his team are responsible for the connection of approx. 2500 pharmaceutical companies and 32 National Medicines Verifications Organisations (NMVOs) to the EU Hub. Further he is active in various Stakeholder Groups (EFPIA, Medicines for Europe, PGEU, GIRP, EAEPC, HOPE and EAHP), representing EMVO vis-à-vis authorities and the EU Commission and presenter/panel member at many congresses.

"According to the Delegated Regulation (EU) 2016/161 Marketing Authorization Holders (MAHs) and Parallel Distributors shall place a unique identifier on the outer packaging of their medicinal products. Related information has to be uploaded to a repositories system. The repositories system is composed of a central information and data router (EU Hub) and national repositories. These national repositories shall be connected to the EU Hub." This is the official statement when you check out the EMVO website on the keyterm of EU Hub On-boarding. What does that mean for pharmaceuticals manufacturers, packagers, distributors.... pretty much for everyone in the industry? In the Opening Keynote of the Pharma TRACKTS! Tobias Beer, as representative on the EMVO, will give you the latest updates, news and must knows about your onboarding process for the EU-Hub. 

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.

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.

Counterfeiting and traceability – The latest and newest from across the globe

Craig Alan Repec is GS1’s subject matter expert for event-based visibility standards such as EPCIS and its companion standard, the Core Business Vocabulary (CBV), as well as the EPC “Gen2” UHF RFID protocol, and Editor of GS1’s EPC Tag Data Standard (TDS). Prior to joining GS1 Global Office in 2011, Craig had similar responsibilities at GS1 Germany, supporting implementations of EPCIS and EPC/RFID, while at the same time actively shaping the ongoing development of these open supply chain standards. Craig is a member of both the GS1 AIDC and GS1 Healthcare teams, and his experience is rounded out by work in software and consulting companies in the United States and Germany over the past twenty years.

Communicating with customers, partners and suppliers is a crucial part of business. But when they all have different processes and systems, even sharing straightforward information can be time-consuming and error-prone. So what is the common language to be used?

Supply chain standards save time and money by reducing administration and paperwork. In term of traceability, a standard can make business also safer for all parties involved. GS1’s standard is tremendously suporting anti-counterfeiting and traceability measurements for the pharma industry.  Learn about the latest and newest from across the globe, regulatory developments worldwide, EPCIS as THE chosen standard as well as experiences and learnings. How to prepare for upcoming deadlines?


Speakers 2016