Prospectus | TOPRA MSc Regulatory Affairs programme

The TOPRA MSc Regulatory Affairs programme is designed for both regulatory professionals who have already gained first-hand experience in regulatory affairs and wish to expand the breadth and depth of their knowledge, as well as for prospective students aspiring to begin a career in regulatory affairs by gaining a comprehensive understanding of the field. 

It is a part-time flexible programme, validated by the University of Hertfordshire, continually adapted to meet the ever-changing demands of the regulatory healthcare environment. Students can choose from 26 modules to ensure the overall programme is tailored to consolidate their own professional practice and provides development opportunities particularly for those who are at the stage of establishing, consolidating and driving their career.

The MSc RA (Medicines/Medical Devices) is unique in that all content is designed, structured and delivered by senior regulatory professionals from both industry and regulatory bodies, which means it always covers the most up-to-date and relevant issues facing regulatory professionals in their everyday practice. This also ensures all graduates have an in-depth knowledge and appreciation of various subjects directly relevant to them. The modules provide regulatory knowledge as well as the skills required to be a highly effective regulatory professional, such as leadership, strategic thinking, management and negotiation. Students on either pathway can choose to take up to two modules from the alternative pathway, offering enhanced flexibility to broaden their regulatory expertise and gain a well-rounded understanding across specialties.

Programme Structure 

The MSc in Regulatory Affairs Programme consists of two stages: Part One, the taught element, and Part Two, the dissertation. Together, they comprise the MSc in Regulatory Affairs.  Students must complete the MSc within six years of their enrolment at the University of Hertfordshire. The official start date for the MSc is the date of enrolment.

The programme offers flexibility, allowing students to begin their studies with any module (excluding the dissertation). It comprises 26 modules, of which students must complete 8 taught modules and the dissertation to earn the master’s degree. 

Operating on a roll-on, roll-off basis, the programme allows students to register for modules throughout the year. Module 0 (Overview of EU Regulatory Affairs) is offered twice a year, while 12 other MSc modules are delivered yearly. This structure provides up to 14 potential entry points per year, enabling students to start at a time that suits their needs. 

The MSc programme is available part-time and has a flexible duration of 1 to 6 years. 

There are 5 final and interim awards based on the path taken as detailed below: 

Assessments

Following each module, the student must complete coursework assignments related to the module topic. The coursework is assessed at defined times during the academic year in which the modules are undertaken.

Submission dates for the course journals and assignments are given at each individual module. A maximum period of three months is allowed for completion of the coursework.

Students are required to satisfy the examiners with respect to the coursework prepared for each module undertaken. Should a candidate fail to satisfy the Board of Examiners, coursework may be resubmitted within a timeframe stipulated by the Board.

Dissertation

Following successful completion of eight modules, students must submit a research-based MSc dissertation (Module 22) of 18,000–20,000 words to achieve the MSc award.

Entry requirements

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, and 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 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.

English Language Requirements for Non-Native Speakers 

Applicants whose first language is not English are required to demonstrate their English proficiency. An IELTS (International English Language Testing System) certificate with an overall score of 6.5 (and no individual component below 6.0) is typically required. 

Alternatively, TOPRA and the university may assess the candidate's English proficiency based on their regulatory work output in English and/or their experience of living and working in the UK or an English-speaking environment.