AGENDA th Serialization Symposium

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Transcription:

AGENDA 2018 6 th Serialization Symposium OCTOBER 15 & 16, 2018

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.

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

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

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

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

Your way to the evening location Haus Ungarn if you are not participating the sightseeing bus tour. Haus Ungarn Karl-Liebknecht-Straße 9 10178 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!