Leadership and Strategic Management in Regulatory Affairs

Leadership and Strategic Management in Regulatory Affairs
This Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department. This is also Module 10 of the TOPRA MSc Regulatory Affairs.

When: 30 January -1 February 2019
Where: De Vere Latimer Estate, Chesham, UK
Start Day 1: 16:00 | End Day 3: 16.00

Course Overview

Lectures and workshops will cover the understanding and application of modern approaches and understanding of managing and building a regulatory department including:

  • Training for a regulatory department
  • IT Support
  • Regulatory intelligence
  • Collaboration with other departments such as pharmacovigilance
  • Marketing
  • Quality control
  • Regulatory Operations
  • Negotiation skills
  • Business planning
  • Budgeting and registration fees
  • The politics or regulation (influencing and lobbying)
  • Product development plans and regulatory project planning and decision analysis
  • Portfolio Management

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

Benefits to delegates

This course will enable you to:

  • Demonstrate a critical knowledge of how to liaise and collaborate with other departments to ensure the appropriate documentation used in development, maintenance and commercialisation of medicinal products and medical devices is in place
  • Possess a comprehensive understanding of the legal requirements and management theory governing regulatory strategies to product development, maintenance and commercialisation
  • Demonstrate the ability to understand the management and leadership skills required to run a regulatory affairs department as a manager, a leader or a member of the RA team
  • Deal with complex issues both systematically and creatively, make sound management judgements in the absence of complete data and communicate your conclusions to the specialist audiences including working with other departments
  • Critically appraise and evaluate communications from regulations, guidelines, research and other publications regarding the management of a regulatory affairs department.


This course provides 19 CPD hours upon successful completion. 

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Download this event's agenda

Module Leaders

Angela Stokes
Syneos Health 

Eva Kopecna
Teva Pharmaceuticals  


TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire.

Ashley Burt
Takeda Pharmaceuticals

Helen Easter
Teva Pharmaceuticals

John Faulkes
Custom Pharma Services

Paul Foster
The RSA Group

Sue Harris
Sue Harris
MHRA (retired) 

Nick Littlebury
Diamond Pharma Services
Jonathan Rousell
Teva Pharmaceuticals

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for a new active substance
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject


    Course fees:
    Type Student Delegate
    Standard    £1500+VAT £1700+VAT 

    Discounted places
    A limited number of discounted places are available at the rates below. 
    Please email us at meetings@topra.org for a discount code before making your booking.

    Those working for regulatory agencies, government agencies or academic institutions 
    Those working for charities, patient groups or in full-time education

    • VAT, if applicable, is charged at the rate of 20% 
    • The registration fee does not include accommodation 
    • Refreshments, lunch and evening meal are included in the registration fee. 

    Related courses

    Practical Document Writing and Management in Practice
    Interacting with your Regulator Workshop
    Module 6: Regulatory Strategy from Development to the Market Place 

    Next steps

    Module 1:Strategic Planning in Regulatory Affairs

    Register now

    Simply log in or create an account and register below. 

    Terms and conditions

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

    30/01/2019 16:00 - 01/02/2019 16:00
    De Vere Latimer Estate Chesham, Bucks HP5 1UG UNITED KINGDOM
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