Regulatory Strategy in the Post Market Phase

Regulatory Strategy in the Post Market Phase
This Masterclass is also Module 17 of the MSc Regulatory Affairs (previously know as Regulatory and Related Activities Through the Device Lifecycle) will provide regulatory affairs professionals with insight into the strategic issues affecting the commercial and regulatory maintenance of a medical device throughout its lifecycle, with focus on post-launch activities and future pressures.



When: 6-8 October 2026
Where: TOPRA Office, 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9DD
Start time Day 1: 13:30 GMT | End time Day 3: 15:45 GMT
 
This course is also available to take part in online

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the regulatory and related activities through the lifecycle
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject


    • Course information

    This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of a variety of topics of importance to the maintenance of the commercial and regulatory health of their company's medical devices once they have been successfully placed on the market. Topics include advertising, data protection and privacy, patents and IP, health technology assessment and reimbursement, environmental legislation and standards, relationships with distributors, own-branders, authorised representatives, trade association and regulatory bodies, product supply and logistics, product liability law, unannounced audits and good regulatory practice.

    Benefits to delegates

    • Demonstrate the ability to critically analyse the legal, regulatory and quasi-regulatory requirements applying to medical devices
    • Apply good regulatory practice particularly when interacting with regulatory bodies, including critically appraising communications
    • Make recommendations about how to prepare for unannounced audits
    • Deal with complex issues both systematically and creatively, make sound judgments in the absence of complete data, and communicate their conclusions clearly to specialist and non specialist audiences
    • Demonstrate a critical understanding of the factors required to maximise the success of a medical device
    • Understand the importance of intellectual property, data protection and product liability and judge when legal advice is required
    • Demonstrate a critical understanding of health technology assessment and reimbursement
    • Critically evaluate the application of environmental legislation and standards to medical devices.
    CPD: This course provides 19 CPD hours upon successful completion

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

    Programme

    A download the course programme here.

    Module Leader

    Jane Arnold-Round






    Jane Arnold-Round
    Principal Medical Research Scientist, Regulatory
    NAMSA - UK 

    Speakers

    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.

       

    Programme

    A download the course programme here.

    Module Leader

    Jane Arnold-Round






    Jane Arnold-Round
    Principal Medical Research Scientist, Regulatory
    NAMSA - UK 

    Speakers

    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.


    Pricing


     Standard training course registration fees
     Event Registration Type Price (GBP)
     Standard Price 
     TOPRA Member    		 £1,900.00 + VAT*
     Standard Price
     Non-member    		 £2,375.00 + VAT* 
     TOPRA MSc Students
          		 £1,650.00 + VAT*

    Save on the full cost of membership and £180     on the price of your training
    course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
    *VAT, where applicable, is charged at the rate of 20%.
     
     Discounted training course registration fees
     Event Registration Type Price (GBP)
     Government or academic rates
     TOPRA Member
    		 £1,425.00 + VAT*
     Government or academic rates 
     Non-member
    		 £1,781.25 + VAT*
     Charities, patient groups, full-time education rates
         TOPRA Member    		 £950.00 + VAT*
      Charities, patient groups, full-time education rates
      Non-member
    		  £1,187.50 + VAT*

    Places are also available for those in low-income countries as defined by the World Bank.
    *VAT, where applicable, is charged at the rate of 20%.
     

    Please email meetings@topra.org for a discount code before making your booking.

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions.
    When
    06/10/2026 - 08/10/2026
    Where
    London UNITED KINGDOM
    Registration begins 31/08/2025
    My registration status: Not registered
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    NOTE
    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 finance@topra.org

    Register now