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Understanding The Basics Of EU Regulatory Affairs - How To Optimise Your Drug Submission Procedures

Management Forum

Course

In The Rembrandt Hotel, London ()

£ 1,275 + VAT

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Description

  • Type

    Course

  • Duration

    2 Days

This course will provide you with an understanding of the basics of EU Regulatory Affairs and the EU legislative framework. Key topics will be covered and strategies discussed to help you improve your regulatory affairs activities and optimise your drug submission procedures. Suitable for: All project team members such as Regulatory Managers and Directors planning on embarking or overseeing an EU Regulatory procedure. For full details, please see brochure.

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Teachers and trainers (2)

Neil Edwards

Neil Edwards

Sirius Regulatory Consulting

Ryta Kuzel

Ryta Kuzel

Director, European Regulatory Affairs, Johnson & Johnson

Course programme

BENEFITS OF ATTENDING:

  • Gain an understanding of the EU Regulatory Legislative Framework
  • Understand the scientific advice procedure ~ what areas should you focus on and what are the potential pitfalls
  • Assess the impact of paediatric investigational plans and how to plan for the best possible outcome
  • Know how to manage the orphan drug designation procedure ~ what are the timings and thresholds
  • Discuss the rising importance of the Risk Management Plan
  • Assess the impact of the Centralised Procedure for registering medicinal products in the EU

See related categories

Understanding The Basics Of EU Regulatory Affairs - How To Optimise Your Drug Submission Procedures

£ 1,275 + VAT

The best Pharmacy courses

See all

See all