Module 11: The US Regulatory Environment - 7FHH1149

The US Regulatory Environment

Next course: November/December 2023

Gives an opportunity to explore in-depth the practical regulatory aspects of regulatory affairs in the US. It covers the regulatory issues likely to arise during drug development and the options available, so that students can provide effective advice on the regulatory affairs activities involved with drug development in the US.


This module enables regulatory professionals to develop and deepen their understanding of all aspects of regulatory operations in the US. Its purpose is to provide students with an understanding of the US regulatory environment within a global context.

It gives such a great overview of the US regulatory environment, providing useful and relevant references, tools and resources."

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Possess a systematic understanding and critical awareness of the regulatory environment and procedures governing regulatory approval of clinical trials in the US and regulatory marketing approval in the context of drug development
  • Demonstrate a conceptual understanding of the regulatory requirements, FDA requirements, regulatory authorisation and associated documentation for marketing submissions
  • Display originality in the application of knowledge of the US regulatory aspects of drug development to critically evaluate current research in the discipline.

Skills and attributes

Successful students will typically:

  • Demonstrate the ability to critically analyse the legal documentation for US drug development
  • Critically appraise and evaluate communications from regulatory bodies (such as the FDA) and critically evaluate research publications
  • Deal with complex issues related to the US regulatory authorisation, both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences.

Focusing on global regulatory affairs? Consider:

  • Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
  • Module 6: Regulatory Strategy: From Development to the Market Place
  • Module 7: Regulatory Strategy for Established Active Substances
  • Module 8: Data for Abridged Applications and Specialised Products
  • Module 10: Leadership and Strategic Management in Regulatory Affairs

Expanding your options? Consider:

  • Module 5: Regulatory Control of Clinical Operations
  • Module 12: Data Management and Digitalisation in Regulatory Affairs
  • Module 18: Drug-device Combinations and Other Technologies

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through to 2025.

  Modules (by number)
Jan - Feb March - April May - July Sep - Oct Nov - Dec
2021 8, 18, 21 0, 9, 10 1, 13, 19 20, 22 0, 2, 12
2022 3, 14 0, 4  5, 13, 15 6. 16 0, 7, 17
2023 8, 18 0, 9 10, 13, 19   20, 22 0, 11, 21 
2024  12, 14  0, 2, 15 1, 13, 22  3, 16 0, 4, 17 
2025 5, 18   0, 6, 19  7, 13  8, 20 0, 9, 21

Visit our Masterclasses page to see which modules are currently open for registration.