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Regulatory Affairs for Support Staff


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Who should attend?

This course is specifically designed for anyone working in Regulatory Affairs, including personal assistants, secretaries, administrators and any member of support staff wishing to gain a greater understanding of Regulatory Affairs in the Pharmaceutical Industry. It is also suitable for those who interface with the Regulatory Affairs function and who provide support to the Regulatory procedures and activities.

Details

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

Why you should attend

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

Course overview

An Overview of Pharmaceutical Regulatory Affairs for Support Staff.

Key Topics to 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

Prices

GBP 1,299.00 EUR 1,819.00 USD 2,026.00 + VAT @ 20.00%

Contact

Leigh White
info@management-forum.co.uk

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