Essentials of European Pharmaceutical Regulatory Affairs

Basics of Pharmaceutical Regulatory Affairs Programme TOPRA Office, 6 th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE

Presenters: •

Arti Gondhia, Regulis Consulting Ltd • Ivan Fisher, G&L Scientific

Time

Presentation

09:30

Introduction to TOPRA

09:50

Introductions

10:05

Setting the Scene

10:30

Overview of Drug Development

11:00

Coffee

11:10

Regulatory Control of Clinical Trials

11:30

Marketing Authorisation Applications

12.00

Product Information (Labelling)

12:10

SmPC game

12:40

Lunch

13:40

European Marketing Authorisation Procedures

14:40

Marketing Authorisation Strategy

14.50

Post- Authorisation Activities

15:10

Review

15:30

Millionaire Quiz

16:00

Close

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