Essentials of European Pharmaceutical Regulatory Affairs

Basics of Pharmaceutical Regulatory Affairs 22 nd November 2018 TOPRA Office, 6 th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE

Programme

Time

Presentation

Presenter

09:30

Introduction to TOPRA

09:50

Introductions

ALL

10:05

Setting the Scene

Lucinda Wells

10:30

Overview of Drug Development

Andrew Thornley

11:00

Coffee

11:10

Regulatory Control of Clinical Trials

Andrew Thornley

11:30

Marketing Authorisation Applications

Lucinda Wells

12:00

Product Information (Labelling)

Lucinda Wells

12:10

SmPC game

ALL

12:40

Lunch

13:40

European Marketing Authorisation Procedures

Lucinda Wells

14:40

Marketing Authorisation Strategy

Lucinda Wells

14:50

Post- Authorisation Activities

Andrew Thornley

15:10

Review

ALL

15:30

Millionaire Quiz

ALL

15:50

Wrap up (Close 16:00)

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