Postgraduate Diploma or Certificate

A postgraduate diploma or a postgraduate certificate gives you the opportunity to gain a qualification in regulatory affairs without making a commitment to the full MSc. At the end of your diploma or certificate course you can choose to carry on and complete an MSc, as long as you would be able to complete the remaining requirements within six years of the date you started.

Current titles are:

  • Postgraduate Diploma Regulatory Affairs (Medicines) – Eight modules in total, this requires at least six modules from modules list A and you can choose up to two modules from modules list B (120 credits in total).
  • Postgraduate Diploma Regulatory Affairs (Medical Devices) – Eight modules in total, this requires at least six modules from modules list B and you can choose up to two modules from modules list A (120 credits in total).
  • Postgraduate Certificate – requires the completion of any four modules from modules lists A or B (60 credits in total).

Frequently asked questions

If you have a question about TOPRA's qualifications programme, you might find the answer on our FAQ page. If you do not find the answer there, please email Kay, our postgraduate administrator.

Forms and documentation

Modules

Modules list A – all modules 15 credits

Module 0 - Overview of EU Regulatory Affairs
Module 1 - Strategic Planning in Regulatory Affairs
Module 2 - Regulatory Strategy for a New Active Substance: Nonclinical Development
Module 3 - Regulatory Requirements for a New Active Substance: Quality
Module 4 - Regulatory Strategy for a New Active Substance: Global Clinical Development
Module 5 - Regulatory Control of Clinical Operations
Module 6 - Regulatory Strategy: From Development to the Market Place
Module 7 - Regulatory Strategy for Established Active Substances
Module 8 - Data for Abridged Applications and Specialised Products
Module 9 - Registration of Biological, Biotechnology and Advanced Therapy Products
Module 10 - Leadership and Strategic Management in Regulatory Affairs
Module 11 - The US Regulatory Environment
Module 12 - Data Management and Digitalisation in Regulatory Affairs
Module 22 – Regulatory Requirements for Cell, Tissue and Gene Therapies

Modules list B – all modules 15 credits

Module 13 - Principles of Medical Device Regulatory Affairs
Module 14 - Design, Development and Certification of Medical Devices
Module 15 - Clinical Evaluation of Medical Devices
Module 16 - Post Market Surveillance and Vigilance for Medical Devices
Module 17 - Regulatory Strategy in the Post Market Phase
Module 18 - Drug-device Combinations and Other Technologies
Module 19 - Regulation of In vitro Diagnostic Medical Devices
Module 20 - Regulation of Electrical, Electronic and Software Devices
Module 21 - US Regulation of Medical Devices
Module 10 - Leadership and Strategic Management in Regulatory Affairs

 

Assessment

Two pieces of coursework will be required for each module and this must be submitted within 3 months of the taught element of the module. The two pieces of coursework will be:

  • A course journal (a critical analysis of the lectures). (50%)
  • Either an essay/briefing document or a poster, as set out in the module handbook. (50%)

Details of the assessment are given at the 3 days of face-to-face teaching.

Terms & conditions

Booking conditions for the MSc Regulatory Affairs modules.