Essentials of European Medical Device Regulatory Affairs

Basics of Medical Devices Regulatory Affairs 27 February 2018

Programme

Time

Presentation

Presenter

09:30 Registration and Coffee 10:00 Introductions

Janis Bayley European Regulatory Affairs, Lilly

10:15

Janis Bayley

Module 1: What is a Device?

10:45

Janis Bayley

Module 2: Who is who

11:00 Coffee break 11:15

Angela Stokes Global Regulatory Consulting, Syneos Health, UK

Module 3: Legislation

11:40

Janis Bayley

Module 4: Classification of devices

12:15 Lunch 13:00

Neil Armstrong Global Regulatory Consulting, MeddiQuest

Module 5: Conformity Assessment

14:00

Janis Bayley

Module 6: Device Labelling

14:25 Coffee break 14:40

Angela Stokes

Module 7: Clinical considerations

15:00

Janis Bayley

Module 8: Post Marketing

16:00 Close of Meeting

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