Module 0: An Overview of EU Regulatory Affairs

This course is also known as our Spring/Autumn Introductory Course that takes place every March and November.

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To provide a brief overview of the many aspects of regulation of medicines in Europe, enabling attendees to understand the legislative framework and practical aspects of EU pharmaceutical regulatory affairs.

Overview

This module is designed for regulatory professionals to develop and deepen their understanding of all aspects of regulatory operations in the EU, and the role of the regulatory affairs function. It will allow them to examine the regulatory requirements imposed on drug development, the processes of preparing regulatory documentation for clinical trial authorisation and marketing authorisation.

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Demonstrate a conceptual understanding of the regulatory requirements: EU directives and legislation; regulatory authorisation and associated documentation for marketing submissions to evaluate current developments critically
• Display a comprehensive understanding of the EU regulatory aspects of drug development
• Possess a systematic understanding of knowledge in 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 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
• Deal with complex issues both systematically and creatively, make sound judgments 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.