Essentials of European Pharmaceutical Regulatory Affairs
Essentials of European Pharmaceutical Regulatory Affairs 28 th March 2019 TOPRA Office, 6 th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Programme
Time
Presentation
Presenter
10:00
Introduction to TOPRA
10:10
Introductions
All
10:25
Setting the Scene
Andy Thornley
10:50
Overview of Drug Development
Chris Parkinson
11:20
Coffee
11:30
Regulatory Control of Clinical Trials
Chris Parkinson
11:50
Marketing Authorisation Applications
Andy Thornley
12:20
Product Information (Labelling)
Andy Thornley
12:30
SmPC game
All
13:00
Lunch
14:00
European Marketing Authorisation Procedures
Andy Thornley
15:00
Marketing Authorisation Strategy
Andy Thornley
15:10
Post- Authorisation Activities
Andy Thornley
15:30
Review
All
15:50
Millionaire Quiz
All
16:20
Close
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