Module 17: Regulatory Strategy in the Post Market Phase - 7FHH1155

Regulatory Strategy in the Post Market Phase

Next course: November/December 2022

Provides insight from a regulatory perspective 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.

Overview

This module enables professionals to deepen their understanding of a variety of crucial areas in the maintenance of the commercial and regulatory health of a 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 (HTA) and reimbursement, environmental legislation and standards, product supply and logistics, product liability law, unannounced audits and good regulatory practice. Relationships with distributors, own-branders, authorised representatives, trade association and regulatory bodies are also covered.

Very interesting course, very informative."

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • 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 be able to judge when legal advice is required
  • Demonstrate a critical understanding of HTA and reimbursement
  • Critically evaluate the application of environmental legislation and standards to medical devices.

Skills and attributes

Successful students will typically:

  • Demonstrate the ability to critically analyse the legal, regulatory and quasi-regulatory requirements applying to medical devices
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences
  • Apply good regulatory practice particularly when interacting with regulatory bodies, including critically appraising communications
  • Make recommendations on how to prepare for unannounced audits.

Developing expertise across the medical device lifecycle? Consider:

  • Module 12: Data Management and Digitalisation in Regulatory Affairs
  • Module 14: Design, Development and Certification of Medical Devices
  • Module 16: Post-Market Surveillance and Vigilance for Medical Devices
  • Module 21: US Regulation of Medical Devices

Expanding your options? Consider:

  • Module 18: Drug-device Combinations and Other Technologies
  • Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies
  • Module 20: Regulation of Electrical, Electronic and Software Devices      

See the table below for the next planned dates for these modules.


Module schedule

The following table outlines the scheduling for all MSc modules through to 2025.

  Modules (by number)
Jan - Feb March - April May - July Sep - Oct Nov - Dec
2021 8, 18, 21 0, 9, 10 1, 13, 19 20, 22 0, 2, 12
2022 3, 14 0, 4  5, 13, 15 6. 16 0, 7, 17
2023 8, 18 0, 9 10, 13, 19   20, 22 0, 11, 21 
2024  12, 14  0, 2, 15 1, 13, 22  3, 16 0, 4, 17 
2025 5, 18   0, 6, 19  7, 13  8, 20 0, 9, 21


Visit our Masterclasses page to see which modules are currently open for registration.