SUPPLY CHAIN TO VALUE CHAIN

Transcription

1 21-22 MARCH 2018 THE OAKLEY COURT, WINDSOR, UK TOGETHER ADDING VALUE CO-ORGANISED BY GIRP AND HDA UK

2 WINDSOR, UK CONFERENCE PROGRAMME CONFERENCE OBJECTIVES Present the latest state-of-the-art technologies in temperature-controlled transportation Demonstrate how collaboration can move the supply chain towards a true pharmaceutical value chain Further the dialogue between supply chain actors and GMDP inspectors Engage participants in further reflections on how to harness the additional benefits from the serialisation project in Europe Explore new options for value creation within the healthcare ecosystem Explore the impact of Brexit on the British and European pharmaceutical value chains TOPICS TO BE ADRESSED Handling temperature sensitive products Temperature controlled storage, monitoring and transportation Experiences from GMDP inspections Medicines batch tracking requirements Electronic delivery notes Responsibilities of responsible person Implementation of the Falsified Medicines Directive 5 KEY TAKE-AWAYS Deep and concrete insight on how to secure an end-to-end temperature-controlled supply chain Clear understanding of GMDP inspectors expectations How to further advance with GDP implementation at national level How to improve business processes with serialisation How to collaborate with your value chain partners

3 CONFERENCE DAY 1 WEDNESDAY 21 MARCH :30 14:00 Welcome Lunch Opening & Welcome Address Mr René Jenny, President, European Healthcare Distribution Association (GIRP) Mr Martin Sawer, Executive Director, Healthcare Distribution Association, United Kingdom (HDA UK) 14:15 Session 1: Seamless handling of temperature sensitive products from production to patient Keynote address Dr. Rafik Bishara, Technical Advisor A review of best practices Panel discussion Moderator: Dr. Rafik Bishara, Technical Advisor Mr Fabian de Paoli, Vaccine Distribution & Cold Chain, GSK Biologicals Mr Claude Jolicoeur, Director Regulatory Affairs, Corporate GMP officer, McKesson Canada Mr Thomas de Bie, CEO, CAPPI Mr Markus Haase, Pharma International Senior Market Manager, Testo 15:30 Coffee Break 16:00 Session 2: Collaborative approaches to temperature-controlled storage, monitoring and transportation Moderator: Mr Olivier Simonnot, Strategic Marketing Manager Life Sciences EMEA, Sensitech Mr Bertrand Nicolau, Distribution and Quality Assurance Director, Supply Chain, Servier and Mr Petr Dvorak, Group Sales Director, PHOENIX Dr. Erik van Asselt, Cold Chain Improvement Manager, Vaccines, MSD Netherlands Mr Roland Duquesne, Director, Strategic Accounts, OEM and Vertical Markets, ThermoKing 17:30 Keynote address Mr Mike Thompson, CEO, Association of the British Pharmaceutical Industry (ABPI) 18:00 Concluding remarks Ms Monika Derecque Pois, Director General, European Healthcare Distribution Association (GIRP) 18:15 End of Conference Day 1 19:30 Networking Reception & Dinner

4 CONFERENCE DAY 2 THURSDAY 22 MARCH :00 Opening remarks Ms Monika Derecque Pois, Director General, European Healthcare Distribution Association (GIRP) 9:15 Session 3: Conversation with G(M)DP Inspectors: Ask the questions you never dared Introduction Mr Andrei Spinei, Scientific Administrator, European Medicines Agency Inspectors panel Topics: transport temperature and temperature excursion handling, digital delivery documentation, overview of wholesale distribution licenses, responsibilities of the responsible person, batch tracking requirements, temperature mapping Moderator: Dr. Rafik Bishara, Technical Advisor Mr Andreas Krassnigg, Head of GMDP Inspections Department, Austrian Agency for Health and Food Safety Ms Emer O Neill, Health Products Distribution Inspections Co-ordinator, Irish Health Products Regulatory Authority Ms Ethel Mertens, Director General Inspection, Belgian Federal Agency for Medicines and Health Products Ms Jacqueline Masayi, GDP Inspector (Inspection, Enforcement & Standards Division), Medicines & Healthcare products Regulatory Agency (United Kingdom) Dr. Ibolya Tarjáni, Head of Department of Inspectorate (Directorate of Inspection and Technology), OGYÉI, Hungarian National Institute of Pharmacy and Nutrition Registered participants will have the possibility to send questions in advance 10:30 Coffee break 11:00 Inspectors panel continued 13:00 Lunch

5 14:00 Session 4: Medicines Verification in Europe how does it work in practice? Moderator: Mr Graham Smith, General Manager, EMEA Special Projects, Tracelink Mr Andreas Walter, General Manager, European Medicines Verification Organisation (EMVO) Mr Charles Young, Business Unit Lead, Solidsoft Reply Mr Pascal Aulagnet, Global Serialization Program Client Partner, Pfizer Mr Grant Courtney, Manager Falsified Medicines Directive Project, GSK 15:30 Coffee Break 16:00 Session 5: The End Game connecting all end-users to the national systems Moderator: Mr Hitesh Varambhia, Life Sciences Business Development Director, Adents Mr Jerome Bertin, General Manager, SecurMed UK Mr Stefan Moch, Head of the NMVO-Business, Arvato Mr Christian Taylor, Business Consultant, Zetes UK Mr Marco Steinkamp, Global Sales Director Track & Trace, Movilitas Mr John Preston, Head of Offsite Dispensing Solutions and Falsified Medicines, Phoenix Healthcare Distribution Ltd. 17:30 Closing remarks and farewell Ms Monika Derecque-Pois, Director General, European Healthcare Distribution Association (GIRP) Mr Martin Sawer, Executive Director, Healthcare Distribution Association, United Kingdom (HDA UK) WE THANK OUR CONFERENCE PARTNERS FOR THEIR VALUABLE SUPPORT