AGENDA th Serialization Symposium

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1 AGENDA th Serialization Symposium OCTOBER 15 & 16, 2018

2 WELCOME TO THE 6 th SERIALIZATION SYMPOSIUM! Bertelsmann Premises, Unter den Linden 1 It is a place where people meet who are fascinated by a building that on the outside tells the story of centuries past, yet reveals a surprisingly modern world within; for opinion makers from politics, business and science to enter into conversation; and for media creators and authors to discuss their work with a critical audience. In short, Unter den Linden 1 has become an institution in the cultural and social scene of Berlin. Please note: We offer exciting topics in two conference rooms. You have the possibility to choose between the individual slots for a topic and are able to change the conference room.

3 OCTOBER 15 09:00 h 10:00 h Arrival and Reception of Attendees including Small Snack 10:00 h 10:10 h Welcome Arvato Systems & Traxeed Conference Room I Serialization Stream 10:15 h 10:50 h Beyond EU Regulation Global Rollout Management from a Manufacturer s Perspective Dr. rer. Nat. Martin Printz, Traxeed 11:00 h 11:50 h Quo Vadis Serialization in Russia 2020 and beyond Christian Mehrmann, Arvato Systems 12:00 h 13:00 h Lunch 13:00 h 13:50 h Product Tracelability Trends in Non-Pharma Industries such as Food and Medical Devices Christoph Staub, Laetus 14:00 h 14:50 h Chances of serialization How to boost shop floor transparency by integrating Arvato CSDB and PAS-X MES Jürgen Laskowski, Werum 15:00 h 15:30 h Coffee Break, Networking & Live Sessions 15:30 h 16:20 h FMD: Wholesale License Holders want to know how to start Pascal Leppich, Arvato Systems 16:30 h 17:20 h Panel discussion FMD fulfilled. What now? Expected benefit FMD 2.0 Next Steps 17:30 h 18:15 h Departure & Sight Seeing Tour Berlin by Bus from 18:15 h Networking Event at Haus Ungarn

4 OCTOBER 15 09:00 h 10:00 h Arrival and reception of attendees including small snack 10:00 h 10:10 h Welcome Arvato Systems & Traxeed Conference Room II NVS Stream 10:15 h 10:50 h Setting the Scene: Big Picture & Status Update Kai Mjaanes, NoMVeC (NMVO Norway) 11:00 h 11:50 h Experiences within the Austrian Medicines Verification System: Fee Model, User Management Dr. Daniel Dangl & Peter Berger-Piascek, AMVS (NMVO Austria) 12:00 h 13:00 h Lunch 13:00 h 13:50 h MAH Onboarding experiences from SecurMed UK Jerome Bertin, SecurMed UK (NMVO UK) 14:00 h 14:50 h Alert Management Dr. Norbert Gerbsch, ACS PharmaProtect Martin Bergen, securpharm (NMVO Germany) 15:00 h 15:30 h Coffee Break, Networking & Live Sessions In Conference Room I: 15:30 h 16:20 h FMD: Wholesale License Holders want to know how to start Pascal Leppich, Arvato Systems In Conference Room I: 16:30 h 17:20 h Panel discussion FMD fulfilled. What now? Expected benefit FMD 2.0 Next Steps 17:30 h 18:15 h Departure & Sight Seeing Tour Berlin by Bus from 18:15 h Networking Event at Haus Ungarn

5 OCTOBER 16 09:00 h 09:30 h Arrival of attendees including small snack Conference Room I Serialization Stream 09:30 h 10:30 h Unique Device Identification (UDI) New Legal Requirements and Timeline under the EU Medical Device Regulation Dr. Boris Handorn, Simmons & Simmons 10:30 h 11:00 h Coffee Break, Networking & Live Sessions 11:00 h 11:45 h US DSCSA & EU FMD Implementations: Challenges faced by a Virtual Pharma Linda Carney, Vertex Pharmaceuticals, Inc. 11:45 h 12:15 h Track & Trace in the context of evolving regulatory requirements Franziska Korrmann, Arvato Systems Falk Nieder, EECC 12:15 h 13:00 h Lunch 13:05 h 13:20 h Conclusion & Summary Arvato Systems /Traxeed 13:30 h Conference Closes

6 OCTOBER 16 09:00 h 09:30 h Arrival of attendees including small snack Conference Room II NVS Stream 09:30 h 10:30 h Closed Group for National Medicines Verification Organisations Please get in contact with Stefan Moch for the agenda 10:30 h 11:00 h Coffee Break, Networking & Live Sessions 11:00 h 12:15 h Closed Group for National Medicines Verification Organisations Please get in contact with Stefan Moch for the agenda 12:15 h 13:00 h Lunch 13:05 h 13:20 h Conclusion & Summary Arvato Systems /Traxeed 13:30 h Conference Closes

10178 Berlin Scan your way to the evening

7 Your way to the evening location Haus Ungarn if you are not participating the sightseeing bus tour. Haus Ungarn Karl-Liebknecht-Straße Berlin Scan your way to the evening event! Google Maps Database System of the Pharmaceutical Industry Our Partners Thank you for your participation at the6 th Serialization Symposium 2018!

SUPPLY CHAIN TO VALUE CHAIN

SUPPLY CHAIN TO VALUE CHAIN 21-22 MARCH 2018 THE OAKLEY COURT, WINDSOR, UK TOGETHER ADDING VALUE CO-ORGANISED BY GIRP AND HDA UK WINDSOR, UK CONFERENCE PROGRAMME CONFERENCE OBJECTIVES Present the latest state-of-the-art technologies