Essentials of European Pharmaceutical Regulatory Affairs

Basics of Pharmaceutical Regulatory Affairs 25 January 2018

Voisin Headquarters, 64 Avenue Pierre Grenier, 92100 Boulogne (Paris), France Programme

Time

Presentation

Presenter

09:30

Introduction to TOPRA

09:40

Introductions

Telmar

09:50

Setting the Scene

Dolores

10:15

Overview of Drug Development

Telmar

10:50

Break

11:05

Regulatory Control of Clinical Trials

Telmar

11:25

Marketing Authorisation Applications

Dolores

11:55

Product Information (Labelling)

Telmar

12:05

SmPC game

ALL

12:35

Lunch

13:35

European Marketing Authorisation Procedures

Dolores

14:35

Marketing Authorisation Strategy

Dolores

14:45

Post- Authorisation Activities

Dolores

15:05

Break

15:20

Review

ALL

15:40

Millionaire Quiz

ALL

16:00

Wrap up

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