The US Regulatory Environment - 7FHH1108

Module Aims:

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

  • Consider and understand regulatory aspects of regulatory affairs in the US
  • 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 in the US.

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 US and regulatory marketing authorisation in the context of drug development
  • Demonstrate a conceptual understanding of the regulatory requirements, FDA requirements, regulatory authorisation and associated documentation for marketing submissions.

Skills and Attributes:

Successful students will typically:

  • Display originality in the application of knowledge of the US regulatory aspects of drug development to evaluate critically current research in the discipline 
  • Demonstrate the ability to critically analyse the legal documentation for US drug development
  • Evaluate complex issues related to US regulatory authorisation, both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and nonspecialist audiences
  • Critically appraise and evaluate communications from regulatory bodies (such as the FDA ) and critically evaluate research publications.