21 - 22 MARCH 2018 THE OAKLEY COURT, WINDSOR, UK

SUPPLY CHAIN TO VALUE CHAIN TOGETHER ADDING VALUE

CO-ORGANISED BY GIRP AND HDA UK

SUPPLY CHAIN TO VALUE CHAIN WINDSOR, UK TOGETHER ADDING VALUE 21 – 22 MARCH 2018

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 • 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         

Rue de la Loi 26, Box 14 T +32 (0)2 777 99 77 E [email protected] 1040 , F +32 (0)2 770 36 01 W www.girp.eu

SUPPLY CHAIN TO VALUE CHAIN WINDSOR, UK TOGETHER ADDING VALUE 21 – 22 MARCH 2018

CONFERENCE DAY 1 – WEDNESDAY 21 MARCH 2018

12:30 Welcome Lunch

14:00 Opening & Welcome Address

• Mr René Jenny, President, European Healthcare Distribution Association (GIRP) • Mr Martin Sawer, Executive Director, Healthcare Distribution Association, (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

Panel discussion with speakers

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 • Mr Roland Duquesne, Director, Strategic Accounts, OEM and Vertical Markets, ThermoKing

Panel discussion with speakers

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

Rue de la Loi 26, Box 14 T +32 (0)2 777 99 77 E [email protected] 1040 Brussels, Belgium F +32 (0)2 770 36 01 W www.girp.eu

SUPPLY CHAIN TO VALUE CHAIN WINDSOR, UK TOGETHER ADDING VALUE 21 – 22 MARCH 2018

CONFERENCE DAY 2 – THURSDAY 22 MARCH 2018

9:00 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

Rue de la Loi 26, Box 14 T +32 (0)2 777 99 77 E [email protected] 1040 Brussels, Belgium F +32 (0)2 770 36 01 W www.girp.eu

SUPPLY CHAIN TO VALUE CHAIN WINDSOR, UK TOGETHER ADDING VALUE 21 – 22 MARCH 2018

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

Panel discussion with speakers

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.

Panel discussion with speakers

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

Rue de la Loi 26, Box 14 T +32 (0)2 777 99 77 E [email protected] 1040 Brussels, Belgium F +32 (0)2 770 36 01 W www.girp.eu