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