Entry to the programme normally requires a Science degree (at the equivalent of a 2.2 or above) and a basic knowledge about regulatory affairs processes, documentation in the healthcare industry and professional skills which include attention to detail, organisation and communication in an area of healthcare product development and lifecycle management.

Candidates that do not possess the formal academic qualifications but have wide regulatory knowledge and skills may also be accepted if they can demonstrate through submission of a portfolio that they are academically suited to complete the course successfully. This portfolio normally includes: a written piece of work; evidence of regulatory knowledge and skills; any higher education level credits already gained. The portfolio will be judged against the following criteria:

The portfolio should:

  • Be coherent and have logical structure
  • Show an ability to reflect critically on the candidate’s own experience in an area of regulatory affairs, healthcare product development and lifecycle management
  • Demonstrate knowledge and understanding of the regulation of medical devices or medicines as shown by a track record in an area of regulatory affairs, healthcare product development and lifecycle management
  • Demonstrate ability to apply regulatory guidance and legislation to practical situations Provide adequate and appropriate selection of literature references

This portfolio will be judged using a numerical rating scale, the candidate needs to achieve 50% or above (pass) for all the criteria above to be admitted to the Programme. The candidates will receive further instructions on how to complete the portfolio, along with these grading criteria, upon request.

If you think this applies to you, please contact TOPRA or the Course Director for a discussion. Entry to the programme is at the discretion of the TOPRA admissions panel and requires approval by the UH Collaborative Partnership Leader.

Overseas applicants

Overseas applicants should normally hold equivalent qualifications to home-based students. An IELTS (International English Language Testing System) certificate 6.5 overall (with no individual component below 6.0) will normally be required for applicants whose first language is not English. The Course Director and the Collaborative Partnership Leader may consider the candidate’s proficiency has been proven by their regulatory work output in English and/or through working and living in the UK or in a company that only communicates in English.