Basics of Pharmaceutical Regulatory Affairs 18 January 2017 - Printer version

18 th January 2017

The Basics of Pharmaceutical Regulatory Affairs

TOPRA, 6 th Floor, 3 Harbour Exchange, South Quay, London E14 9GE

ENABLING AND PROMOTING EXCELLENCE INTHEHEALTHCARE REGULATORY PROFESSION

Basics of Regulatory Affairs - Objectives

To provide an awareness of the regulatory environment for medical products, and an appreciation of some of the main regulatory processes and issues including:

• Understand how and why regulations arose • Understand the roles of regulatory affairs staff • Gain an overview of the drug development process • Understand how drugs are registered and maintained

The emphasis will be on EEA Regulatory Processes

What will we look at today?

History of regulation

EU / US / Japan

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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