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Pharma

Serialisation And Tracking Of Pharmaceutical Products Summit

  • 19th – 20th April 2018
  • Germany flag Germany Berlin
  • Hotel Eurostars Berlin Friedrichstraße 99, 10117

Counterfeit medicines have become an enormous problem in many parts of the world. EU has introduced the Falsified Medicines Directive, which is here to help prevent prescription drugs from being misbranded, sold after expiry, counterfeited, diverted, stolen and contaminated. All manufacturers, wholesalers, re-packagers, OEMs and pharmacies must adapt to the new regulatory landscape.

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About

There is no doubt that serialisation will change the way companies are distributing their products. Packaging, commercial relationships with customers, regulatory activities, and the way they are managing their data will be heavily impacted as well.

It will also trigger the wave of challenges companies will be facing: in their manufacturing, operations and supply chain management processes.

This is the exact reason we decided to run this event and provide a platform for an essential dialog between pharma companies and CMOs, CPOs, CDMOs.

Global pharma companies will learn how to build enterprise-wide strategies and technology infrastructures to handle the markets on a consistent way. And contractors will have an opportunity to discuss how to handle different requirements from different customers.

The event will be covering a range of real life case studies: starting from the impact serialisation has on company’s management processes, how to find a qualified supplier, how to fund the changes in packaging lines, all the way to IT matters. Knowledge sharing provided at this event will ensure that all industry players are ready to successfully face regulatory deadline.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Managers and Technologists specialising in:

  • Serialisation
  • Track and Trace
  • Anti-Counterfeiting Strategies
  • Operational Technology
  • Corporate Projects
  • Manufacturing & Packaging
  • It Infrastructure/Applications Logistics/Consulting
  • Packaging/Labeling
  • Packaging/Labeling
  • Product Engineering Services
  • Quality Assurance
  • Traceability
  • Supply Chain Management/Security/Risk Management/Integrity/Visibility
  • Engineering & Technology
  • Operational Excellence
  • Program Management
  • Brand Management/Protection/Security/Integrity
  • Manufacturing Systems/Process/Quality Control
  • Automation
  • Product Security
  • Regulatory Science/Compliance

Company Types:

  • Pharmaceutical
  • Anti-Counterfeiting Organizations/Service Suppliers
  • Device/Packaging/Labeling Companies
  • Pharmaceutical Associations
  • CROs
  • CMOs
  • CDMOs
  • Biotechnology
  • Authentication Technology Suppliers
  • Drug Regulatory Agencies, Customs And Police
  • IT Consulting & Applications
  • 3PLs
  • CPOs
  • NOPs

Key Practical Learning Points

  • Maintaining the pace of the manufacturing process while implementing a serialisation solution
  • Meeting the challenges of serialisation: a contractor’s perspective
  • Implementing a solution that can be tailored for changing needs: from planning to deployment
  • Assuring the line and supply chain readiness
  • Serialisation, reporting, and product verification highlights
  • Understanding the key technology requirements and defining the project scope
  • Lessons learned from around the world
  • Involving IT in the earliest stages of the implementing of serialisation solution
  • How to prepare to the secure and reliable master data exchange

Staffan Widengren, SE

Director Corporate Projects

Recipharm AB

Staffan Widengren, Director of Corporate Projects at Recipharm, has since June 2015 acted as programme manager for the Recipharm global serialisation project and part of a global steering committee that is working closely with Recipharm’s clients to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialisation. Staffan has been in the pharmaceutical industry since 1988. From 1988 until 2002, he worked at Kabi and Pharmacia within quality as QA manager and qualified person. In June 2002, he joined Recip (Recipharm) as the vice president of QA/ QC and qualified person. In May 2007, he was appointed as the general manager for Recipharm Strängnäs AB. Recipharm Strängnäs AB produce various types of penicillin.

Antoine Tracq, FR

BLUE Serialization Program Manager

Nestlé Skin Health

Antoine Tracq is program manager of global serialization at Galderma, Nestlé Skin Health in Lausanne. In this position, Antoine is responsible for the company‘s strategic development in serialization, meaning the definition and deployment of the overall strategy for Global Serialization across the company (HQ, plants, affiliates and business partners). He is also responsible for business processes & solutions. Furthermore, Antoine is in charge of general management and coordination of building and managing specific teams to achieve targets based on regulatory and business needs. He is accountable for program/ project management, leading through an on-going program for all projects/streams under Global Serialization landscape focussing on scope, costs, timeline, and risks. Antonie holds a master’s degree in science integrated systems and engineering, while also having a Black Belt Certification for lean manufacturing.

Jean Marie Aulnette, UK

Vice President, Europe Middle East & Africa (EMEA)

TraceLink

Jean-Marie Aulnette is the vice president of Europe, the Middle East, and Africa (EMEA) sales at TraceLink. With over 20 years’ experience in international sales, he is responsible for building and leading the company’s EMEA business. He also has extensive experience in enterprise SaaS applications. His main focus at TraceLink is to deliver track and trace solutions across EMEA pharmaceutical markets to ensure visibility, traceability, and compliance throughout the supply chain. Jean Marie joined TraceLink in 2014 and has previous experience in developing enterprise solutions to help improve business processes. He also holds a master’s degree in business from Centre d’Etudes Supérieures en Management International (CESMI), Groupe ISG.

Collins Agoro, DE

Project Engineering Manager Serialization

B.Braun Group

Collins Agoro is an engineering professional with 7 years’ experience in the field of engineering focusing on project management, process design and development, project monitoring, and evaluation. His professional experience spans the manufacturing, oil & gas, construction, and pharmaceuticals industries. I have also worked in various parts of the globe namely Africa, Middle East, and Europe.

He is currently the project manager for Track and Trace in B.Braun Melsungen AG in the Global Process Engineering Department, responsible for EU-FMD implementation. His responsibilities entail EU-Hub onboarding, NMVO contract management process, global serializations legislations evaluations, serialization workflow developments, and risk analysis in serialization implementations.

Tobias Beer, BE

Head of Commercial & Partner Management

European Medicines Verification Organisation

Tobias Beer has over 8 years’ experience in pharmaceuticals, where he has 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 the 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. Furthermore, 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.

Sébastien Mauel, CH

Head of Serialization & Product Security

Ferring International Center

Sebastien Mauel is head of serialization and product security at Ferring Pharmaceuticals. He is responsible for Ferring’s global serialization programme, whose goal is to ensure Ferring products, manufacturing sites, and IT infrastructure comply with the various serialization regulations worldwide. He is also in charge of developing and implementing the product security strategy to protect Ferring’s patients and assets against pharmaceutical crime.

Prior to that role, Sebastien worked within manufacturing, logistics, CMO management, supply chain management and product security roles at Serono, Ares Trading, and Merck KGaA in Switzerland and Germany. Sebastien holds a master degree in chemical engineering from the Swiss Federal Institute of Technology, and CPIM and CSCP certifications from APICS.

Marie-Lyn Hecht, CH

Principal | Member of the Management Board

Strategy & PwC

Dr. Marie-Lyn Hecht is a principal in the Pharma & Life Science practice at Strategy& based in Zurich. Her focus is on R&D and M&S strategies for pharmaceutical companies. She has previously worked in Boston, Berlin, and Munich and has an in-depth understanding of the healthcare industry and the latest trends. Marie-Lyn has over 10 years of combined pharmaceutical consulting and biomedical research experience.

Robbie Stewart, UK

Director of Business Development, Commercial Packaging Services

PCI Services

 Stewart has 20 years’ experience within the consumer healthcare, pharmaceutical, and biotech industries. After beginning his career with The Boots Company, he has held senior commercial positions with a number of global pharmaceutical organisations including Catalent, Aptuit, and Encap Drug Delivery (now part of Lonza). He was also involved with the start-up of a leading comparator sourcing company, Clinigen. His background spans drug development, manufacturing, clinical trials supplies, and commercial packaging services. In his current position with PCI Pharma Services, he is responsible for commercial packaging and serialisation services within Europe.

Martin FitzGerald, BE

Deputy Director General

GIRP (European Healthcare Distribution Association)

Martin FitzGerald is the deputy director general for the European Healthcare Distribution Association (GIRP). Martin’s duties include day to day management, supporting the implementation of the strategic and policy decisions of the associations governing bodies, and managing the association’s relations with its member organizations, authorities, and other stakeholders. With a legal background, he also deals with the broad range of legislative and regulatory issues affecting pharmaceutical full-line wholesalers as well as healthcare distributors in Europe. GIRP is the umbrella organisation for pharmaceutical full-line wholesalers and distributors of healthcare products and services in Europe. It represents the national associations of over 750 pharmaceutical wholesalers serving 35 European countries, as well as major international and pan-European healthcare distribution companies.

Yoram Eshel, IL

Former Senior Director, Head of Global Transportation & Logistics

Teva Pharmaceutical Industries Ltd.

Yoram Eshel is former senior firector, head of global transportation and logistics in Teva Pharmaceutical Industries Ltd. He has been with Teva since 2003, working in the US for 5 years, and in Israel for 8 years. He has also been acting as the head of economic department in Israeli Export Institute.

Yoram holds an MBA in economics and business administration. He has vast experience in global transportation, warehousing and distribution systems and processes, forwarding, customs and trade compliance programs, GDP and temperature management, security, safety, and environmental implications. Yoram is specialized in the pharmaceutical, biological and API industries including clinical trials, medical devices, and specialized pharmaceuticals.

Pierre Rågstad, SE

CEO & Private Consultant

PRCC

Pierre Rågstad (B.Sc) has more than 15 years of experience within management, working for companies such as AstraZeneca, Pharmacia, Pfizer, and Recipharm. Pierre has extensive experience working as a project manager and PMO and for the last 2 years worked as deployment project manager, responsible for 7 sites across Europe.

Dr. Darius-Jean Namdjou, DE

Associate Director Global Regulatory Affairs

Grünenthal GmbH

Dr. Darius-Jean Namdjou graduated as a Ph.D. chemist from Aachen University, Germany, in 2006. After a two-year Post-Doc stay at the National Research Council in Ottawa and further professional training, Darius joined the headquarters of Grünenthal GmbH, Germany as regulatory affairs manager in 2009. Darius gathered two years’ experience with the coordination of marketing authorization and lifecycle activities in emerging and further RoW markets, covering the product portfolio of Grünenthal. Since August 2011, Darius leads regulatory affairs product teams, on a global level, for several of Grünenthal’s established pain products. Darius’ latest projects also focus on development activities for Europe and Latin America.

Darius is the representative for regulatory affairs in Grünenthal’s serialization project team. He is a member of the EFPIA Expert Group for exchanging information on the regulatory aspects of FMD implementation.

Craig Alan Repec, BE

Senior Manager, Supply Chain Visibility, EPCIS & RFID

GS1

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 “Gen2” UHF RFID protocol, and he is Editor of GS1’s EPC Tag Data Standard (TDS). Prior to joining GS1’s global organisation 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.

Staffan Widengren, SE

Director Corporate Projects

Recipharm AB

Antoine Tracq, FR

BLUE Serialization Program Manager

Nestlé Skin Health

Jean Marie Aulnette, UK

Vice President, Europe Middle East & Africa (EMEA)

TraceLink

Collins Agoro, DE

Project Engineering Manager Serialization

B.Braun Group

Tobias Beer, BE

Head of Commercial & Partner Management

European Medicines Verification Organisation

Sébastien Mauel, CH

Head of Serialization & Product Security

Ferring International Center

Marie-Lyn Hecht, CH

Principal | Member of the Management Board

Strategy & PwC

Robbie Stewart, UK

Director of Business Development, Commercial Packaging Services

PCI Services

Martin FitzGerald, BE

Deputy Director General

GIRP (European Healthcare Distribution Association)

Yoram Eshel, IL

Former Senior Director, Head of Global Transportation & Logistics

Teva Pharmaceutical Industries Ltd.

Pierre Rågstad, SE

CEO & Private Consultant

PRCC

Dr. Darius-Jean Namdjou, DE

Associate Director Global Regulatory Affairs

Grünenthal GmbH

Craig Alan Repec, BE

Senior Manager, Supply Chain Visibility, EPCIS & RFID

GS1

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