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  

  • Presenters

    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

    John Deavin
    Deavin Associates

    Helen Easter
    Teva Pharmaceuticals

    John Faulkes
    Custom Pharma Services

    Paul Foster
    The RSA Group
    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

      Please read the training terms and conditions before booking this course. 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
      Your VAT country
      Your Vat number
      If your company VAT number does not appear here or you would like to be invoiced using a different VAT number please email finance@topra.org

      Register now

      Our policy on photography and video

      On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

      However, if for any reason you do not wish TOPRA to use your image or voice please let us know

      Recording and photography by delegates is not permitted.