Preconference Workshop

In Vitro Diagnostics Regulation (IVDR)

Monday, October 26, 2020

08:30 – 15:30 CET

Session Leader/Speaker(s)

Anja Wiersma, PhD

Chair of Board of RAPS Netherlands Chapter, CEO of mi-CE consultancy
mi-CE consultancy
Valburg, Gelderland, Netherlands

Speaker(s)

Erica Conway, PhD

Global Head - In Vitro Diagnostic Medical Devices
BSI (London)
Milton Keynes, United Kingdom
Simon Richards, PhD

Vice President Divisional Regulatory Affairs
Abbott Rapid Diagnostics
Scarborough, Maine, United States
MN

Micha Nuebling, PhD

Head Department
Paul-Ehrlich-Institut
Langen, Hessen, Germany
Philipp Hohenbrink, Dr rer nat

Senior Consultant
Medical Device Safety Service GmbH
Hannover, Niedersachsen, Germany
Claudia Dollins, PhD

Head, Global Regulatory Affairs, Translational Medicine & Devices
Merck Healthcare KGaA

You can register for this Pre-Conference workshop until Friday 23 October via the RAPS Euro convergence website: https://www.raps.org/europe-2020/register. Once you have registered you will get the webcast link for the meeting.
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Agenda:

08:30 – 10:00
1. IVDR basics -IVDR Structure: Anja Wiersma, mi-CE
2. Classification and conformity routes: Philipp Hohenbrink MDSSAR

10:00 – 10:30: Coffee Break

10:30 – 12:00
1. Technical Documentation requirements: Simon Richards, Abbott rdx
2. Performance Evaluation: Anja Wiersma . mi-CE

12:00 – 12:30: Lunch

12:30 - 14:45
1. Working with Notified Bodies: Erica Conway, BSI
2. Update on Reference Laboratories for IVDs: Micha Nuebling, PEI
3. Companion Diagnostics: Claudia Dollins, Merck

14:45 - 15:00: Coffee Break

15:00 - 15:30
Closing session: Open panel and questions session