The US Regulatory Environment

The US Regulatory Environment
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of regulatory operations in the US.  This is also Module 11 of the TOPRA MSc Regulatory Affairs.

 30 October - 1 November 2023
Where: Fletcher Hotel-Restaurant Wings-Rotterdam

Also available as a virtual course, please click here for the virtual registration option.

Course overview

The purpose of this course is to provide an understanding of the regulatory environment in the US in order to place its global influence in perspective. 

Lectures and workshops will cover understanding of US drug development including:

  • The history of drug regulation in the US
  • The legal basis of regulatory affairs in the US
  • Common application types (eg, IND, NDA, BLA, ANDA and SNDA)
  • OTC products
  • Orphan drugs
  • Fast track approvals
  • Adverse event reporting
  • Labelling
  • Advertising and advertising controls
  • Communicating with the FDA.

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable students to contextualise their understanding and knowledge. 

Benefits for delegates

This course will enable you to:

  • Posses 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
  • 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
  • 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.

CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


You can view and download a copy of the draft programme based on previous courses here.

Module Leader(s)

  •  Nancy Smerkanich - Assistant Professor, University of Southern California School of Pharmacy

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the US regulatory environment
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject


    Course fees*:
    Type Student Delegate
    Standard   £1,500 + VAT* £1,700 + VAT* 

    Discounted places
    A limited number of discounted places are available at the rates below. 
    Please note that discounted places are not valid for those enrolled on the MSc course.
    Please email us at for a discount code before making your booking. 

    Those working for regulatory agencies, government agencies or academic institutions 
     £1,275 + VAT*
    Those working for charities, patient groups or in full-time education
       £1,275 + VAT*

     *VAT, if applicable, is charged at the local rate of 21%.

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions


    Simply log in or create an account and then register using the 'Register Myself' button that will appear below once you are logged in. 

    30/10/2023 - 01/11/2023
    Fletcher Hotel-Restaurant Wings-Rotterdam Rotterdam Airportplein 55 3045 ROTTERDAM NETHERLANDS
    Sign in or create an account to register Registration ends 29/10/2023 12:00 (GMT Standard Time)
    My registration status: Not registered
    Your company name
    Your VAT country
    Your VAT number
    Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email

    Register now