Online prospectus | TOPRA MSc Regulatory Affairs programme

The TOPRA MSc Regulatory Affairs programme is designed for regulatory professionals who have already gained first-hand experience in regulatory affairs and wish to increase the breadth and/or depth of their knowledge.

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 23 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 consolidating or 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 have the opportunity to take up to two modules from the other pathway – enabling greater flexibility to broaden their regulatory expertise across specialties.

Course structure

The MSc RA programme is offered in part-time mode taking one to six years, depending on the final level of postgraduate qualification – certificate, diploma or masters.

Students may join the programme at the start of any of the scheduled modules as the programme does not follow a traditional semester entry format. Modules run on a three-year cycle with a total of five medicines modules, including the Overview of EU Regulatory Affairs (Module 0), which runs twice a year, and four medical devices modules taking place each year.

Students for either the Medicines or Medical Devices pathway can take up to two modules from the other pathway to allow great flexibility in tailoring their qualification.

Students not wishing to commit to the full MSc are able to register for a postgraduate diploma (requires eight modules, including the option to take two from the alternative pathway), or a postgraduate certificate (requires four modules). Students registering for the postgraduate certificate may take any four modules from either the Medicines or Medical Devices pathways. Any student who has registered for the PG Dip or PG Cert can transfer onto the full MSc RA during their programme.

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 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.