The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering

This two day course provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

You will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market. Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products. The course will provide a thorough grounding in the subject of Regulatory Affairs and enable you to perform in your role more effectively.

Key Topics to be be covered:

  • Understand the Background of EU Law - Regulations, Directives and guidelines
  • Discover where you can find information on regulatory affairs, approvals, withdrawals etc
  • Assess the impact of the EU Clinical Trials Regulation
  • Gain an Understanding of the Common Technical Document
  • Discuss how to apply for a marketing authorisation in the EU - the Centralised, Decentralised and Mutual Recognition Procedures
  • Clarify Post Authorisation Obligations - Pharmacoviglance, variations and renewals

For more information about this conference visit https://www.researchandmarkets.com/research/8r578q/2_day_course?w=4