Regulatory & Related Activities Through the Device Lifecycle

Regulatory & Related Activities Through the Device Lifecycle
This Masterclass is also Module 17 of the MSc Regulatory Affairs and 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
: 2–4 November 2022
Where: TOPRA Office, London, UK
Start time Day 1: 13:30 GMT | End time Day 3: 15:45 GMT
 

Course overview

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 copy of the draft agenda can be downloaded HERE

Module Leader

Jane Arnold-RoundJane 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. Confirmed speakers for this course:

 

This course is 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
  • Pricing  

      Course fees:
      Type Student Delegate
      Standard    £1500+VAT £1700+VAT 
      * VAT, if applicable, is charged at 20% 

      Discounted places
      A limited number of discounted places are available  for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at £1275+VAT 
      Please email us at meetings@topra.org for a discount code before making your booking.
      Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.

       


      Terms and conditions

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

      When
      02/11/2022 - 04/11/2022
      Where
      London UNITED KINGDOM
      Sign in or create an account to register
      My registration status: Not registered
      Your company name
      Your VAT country
      Your VAT number
      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