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MSc Regulatory Affairs: Frequently asked questions

Who is eligible to register for the MSc Regulatory Affairs?

All applicants must meet the entrance requirements, which normally include relevant experience of working in Regulatory Affairs or other relevant areas of the pharmaceutical industry and a science degree (or cognate discipline), or the equivalent in the opinion of the Admissions Panel.

Applications meeting the above criteria will be accepted automatically.

In exceptional circumstances TOPRA will consider applications from potential candidates who do not meet the above criteria, for example:

  • Many years experience in regulatory affairs, but no degree
  • Degree but insufficient regulatory experience

In such cases the application will be reviewed by the Admissions Panel to assess suitability for acceptance onto the course.


Language

Candidates whose first language is not English must prove their knowledge of written and spoken English is sufficient to enable them to undertake the course. An IELTS (International English Language Testing System) certificate must be submitted before you begin the course. The University specifies that students studying for an award need to have attained an IELTS score of 6.5 or equivalent. Please be award that the University of Hertfordshire no longer accepts TOEFL certificates.

Information on IELTS can be found at www.ielts.org and www.britishcouncil.org


Disability

TOPRA makes no distinctions in its admissions policy with regard to disability. TOPRA will make every reasonable effort to supply students with services that meet their needs.


Do I have to decide at the beginning of the course which modules I wish to attend?

No, but in order to guarantee a place it is helpful if students decide which modules to take before the start of each academic year.


Do I have to commence the course with the Overview of EU Regulatory Affairs (7FHH1097)?

No, you may start the course with any module, however it may be suggested that you do start with this module or take it as one of your selected modules if it is deemed by the Admissions Panel that you do not have relevant regulatory experience. The order of selection is the student’s own personal choice. The first day of the first module attended is the official start date for students enrolled on the course.


Do I have to study for the full MSc or can modules be undertaken on a single, free-standing basis?

While priority is given to registered students, participants may be accepted onto one or more modules if space permits.

There are no formal entry requirements for non-students, but delegates should be sufficiently experienced to be able to contribute appropriately. This is a suitable option for personnel wishing to increase their knowledge of specific areas of Regulatory Affairs, without the need to pursue the additional studies required to pass the MSc.


If I take a few modules on a free-standing basis and then decide to take the MSc, can previous modules contribute?

The student should preferably decide before undertaking a module whether or not it will contribute towards the MSc.

Sometimes a student takes his/her initial module as a non-MSc student and then decides to register for the MSc. In such a case the initial module may count towards the MSc provided s/he makes an application immediately following the module.


What does an MSc Regulatory Affairs student have to do?

  • Attend 8 modules
  • Follow up each module with private study and prepare a course journal and written assignment/s related to the subject of each module.
  • Complete an additional MSc dissertation of 18,000 – 20,000 words. The topic is the student’s choice, but subject to the approval of the Course Director and Examiners.
  • Students can also gain an interim award of a Postgraduate Certificate in Regulatory Affairs after completion of four modules or a Postgraduate Diploma in Regulatory Affairs after the completion of eight module.

How much work does a student really have to do?

Be prepared to work hard! At the modules, the student will be provided with a great deal of information that will offer guidance. As with any postgraduate course it is then up to the student to find further information so as to develop a wide-ranging breadth of knowledge and an information base.

Students are expected to prepare appropriately for each module and, for each module, to complete the course journal and written assignment/s. This independent work is expected to take an approximately an additional 80 hours per module. The course journal is prepared by collecting and analysing reference material relevant to the subject of the module, eg pertinent guidelines or published references. Also, written assignment/s must be completed. Currently this is one from a choice of three questions and the other being a compulsory problem-based analysis four months after the module ends. From February 2018 under the new MSc rules, this will be cut down to a course journal and one additional assignment to be completed within three months of the end of the module.

The student’s ability to build up an information base in the form of a course journal is assessed for each module; the student must demonstrate that they understand the significance of the information gathered, analyses and relates it to areas of drug development or industrial practice. Understanding, interpretation and presentation of facts and arguments are tested by preparation of the written assignments. By the time the student has participated in the module, researched the topic and satisfactorily completed the written assignment/s, an in-depth knowledge of the subject of the module should have been acquired.

The percentage of marks awarded for each element, course journal, written assignments and dissertation is detailed in the Student Handbook, available on request from the TOPRA office.


What type of work is involved in preparing an MSc dissertation?

The MSc dissertation is a research-based dissertation. The selection of a topic involves thinking of a regulatory-related subject that can be researched with the aim, like all research, of answering questions.

The regulatory field has many open questions. For example: is the non-clinical testing carried out on biotechnology products suitable to identify the potential risks? Answering this question could involve finding out from the public domain (scientific and industrial literature, product information available on request, eg SBA, EPAR) or research of the student’s own company, such as what testing has been done on a range of approved products (The Research). Then this information should be analysed (comparing the testing between products, with guidelines, with clinical use, with non-biotechnology products); the findings discussed and conclusions drawn. (Note: This outline is provided to demonstrate as an example how research can be applied to regulatory topics rather than the laboratory situation. It is not formal guidance.)

Students preparing to undertake the dissertation will be briefed further during their studies and asked to send in a research proposal to the Course Director, using the required application form.

Details required include proposed title, research aims, methods and analysis, together with details of a proposed supervisor. On the basis of information supplied, the Examiners and Course Director will determine if the proposal is acceptable or needs revision.


What else should I consider before embarking on the course?

Studying for the MSc Regulatory Affairs requires a considerable commitment from the student and his/her employer. The amount of studying required in addition to attendance at the modules is described in the prospectus. This information should help you decide if the course is the right one for you.

The Student Handbook should be read before attending the initial module as it gives full details of the regulations governing the course together with relevant practical information. All students receive a copy of the handbook when they are admitted to the course.