Overview of EU Regulatory Affairs - 7FHH1097

This module lasts for four days and is available to non-MSc students as the successful and well-established Introductory Course.

Module Aims:

The aims of this module are to enable students to...

  • Consider and understand regulatory aspects of regulatory affairs in the EU
  • Explore and appreciate the regulatory issues likely to arise during drug development in order to be able to provide effective advice on the regulatory affairs activities involved with drug development.

Learning Outcomes

Knowledge and Understanding:

Successful students will typically:

  • Possess a systematic understanding of knowledge, and a critical awareness of the regulatory environment and procedures governing regulatory approval of clinical trials in the EU and regulatory marketing authorisation in the context drug development
  • Demonstrate a conceptual understanding of the regulatory requirements EU directives and legislation regulatory authorisation and associated documentation for marketing submissions to evaluate critically current developments
  • Display a comprehensive understanding of the EU regulatory aspects of drug development.

Skills and Attributes:

Successful students will typically:

  • Demonstrate the ability to critically analyse the legal documentation and guideline considerations of EU regulatory affairs
  • Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences in relation to obtaining regulatory authorisation
  • Critically appraise and evaluate communications from regulatory bodies and research publications.