TOPRA EU Essentials Aug2016 FINAL

11/10/2016

Essentials of European Regulatory Affairs

©August2016

Presented by: Patricia Anderson, Helen Edelberg, Carlos Langezaal, Malcolm Lloyd Smith

ENABLINGANDPROMOTINGEXCELLENCEINTHEHEALTHCAREREGULATORYPROFESSION

Essentials of European Regulatory Affairs - Objectives

©August2016

To provide awareness of regulatory environment and appreciation of some key regulatory processes and issues including:

• Understand how and why regulations arose

• Understand roles of regulatory affairs staff

• Gain overview of drug development process

• Understand how drugs registered and maintained

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What will we look at today?

©August2016

History of regulation

EU

Drug Development

What does Regulatory Affairs do and when do we do it

To approval and beyond

Communication

Regulatory Authorities

Future Challenges

Dossiers

Labelling

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