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European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations


This intermediate course provides description and discussion of the complete spectrum of necessary regulatory procedures: marketing authorization registration procedures, variation procedures, renewal procedures and more. An expert instructor will use practical examples and experiences to illustrate procedures. The course focuses on Europe, but also reviews regulations in other regions including the US and Japan.

What you will learn

  • Drug Regulations
  • Role of Regulatory Affairs in Drug Development / Approval / Marketing
  • Registration Dossier
  • Regulatory Strategy
  • Variations: The Role of Regulatory Affairs after Marketing Authorization
  • Transparency in Drug Regulatory Affairs

Who should attend?

This course provides the knowledge and tools for experts and managers from the regulatory agencies and pharmaceutical industry working in the areas of:

  • Regulatory Affairs
  • Clinical drug development
  • Preclinical drug development
  • Pharmaceutical development
  • Manufacturing
  • Drug quality control
  • Quality assurance and compliance
  • Regulatory writing
  • Drug import /export

Learning objectives

At the conclusion of this course, participants should be able to:

  • Define the drug legislation and regulation with a focus on the EU
  • Demonstrate successful knowledge of the Internet to locate relevant documents
  • Identify the key functions of regulatory affairs during the different phases of a drug life cycle
  • Formulate successful regulatory strategies and apply it to the product concerned

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