Pharmaceutical Regulatory Affairs: An Introduction

17 April: 10-12h - 24 April: 10-12h - 8 May10-12h - 22 May: 10-12h - 29 May:10-12h - 5 June: 10-12h -12 June: 10-12h - 19 June: 10-12h - 26 June : 4 hrs / 8 - 12.

Dr Pierre Humbert-Droz, CMC Expert Consultant (MITC SA) / GSK Consumer Healthcare

The objective of this course is to give an overview of the worldwide regulatory environment and regulatory requirements governing the pharmaceutical industry. It will provide an understanding of this dynamic discipline which combines science & regulations and offers large opportunities for interesting careers at the interface between pharmaceutical company's various departments. It will describe the regulatory environment in the major regions of the globe to support development of new products to obtain marketing authorizations. This course will also provide an introduction to the lifecycle management, focusing on drug products & medical devices together with considerations on trends and future within the pharmaceutical industry.

UNIGE, CMU, room A04.2608

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