Leadership and Strategic Management in Regulatory Affairs

Leadership and Strategic Management in Regulatory Affairs
This course was previously advertised for 8th-10th May, but has been changed due to the new UK Bank Holiday. Module 10 of the MSc and Masterclass: 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/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment.

When: 9 - 11 May 2023
Where: Online

Also available as a face-to-face course, please click here for the face-to-face registration option.

Course Overview

Lectures and workshops will cover the understanding and application of modern principles, approaches and understanding of leadership and strategic management in regulatory affairs including:

  • Recruitment, training and development  of regulatory affairs departments
  • Regulatory affairs during mergers and acquisitions
  • Competitive advantage of regulatory affairs
  • Regulatory intelligence
  • Collaboration with other departments such as pharmacovigilance/vigilance
  • Regulatory Operations
  • The politics of regulation (influencing and lobbying)
  • Product development plans and regulatory project planning and decision analysis
  • Product management 

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable you to contextualise your understanding and knowledge of strategic planning.

"All lectures were extremely interesting and engaging." – 2018 attendee

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 judgments in the absence of complete data and communicate your conclusions to the specialist audiences including working with other departments
  • Appraise and evaluate communications from regulations, guidelines, research and other publications regarding the management of a regulatory affairs department.
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 programme here

Module Leaders

Angela Stokes
Angela Stokes
Sharp Regulatory Consulting 
Eva Kopecna
Eva Kopecna
Acino International


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. In addition to the module leaders listed above, previous speakers for this course include: 

Daniela Drago - Chief Regulatory Officer, Aurion Biotech
Stephan Hütter - Director Global Program Management, PharmaLex

Suitable for

  • Delegates from the regulatory affairs industry who wish to develop their knowledge in leadership and management of regulatory affairs
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject


    Course fees*:
    Type   Delegate
    Standard     £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 meetings@topra.org 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 rate of 20% 

    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. 


    09/05/2023 - 11/05/2023
    Registration is closed. Please contact meetings@topra.org for further information.
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