Am I eligible to register for the MSc Regulatory Affairs?
All applicants must meet the entrance requirements. These normally include relevant experience of working in regulatory affairs or other related areas of the pharmaceutical or medical device industry and a science degree.
However, candidates not meeting these criteria may be considered. For example, if you have many years’ experience in regulatory affairs, but no degree, you will need to submit a portfolio to support your application. Alternatively, you may have a degree but limited experience. In such cases, the Admissions Panel considers applications on a case-by-case basis to assess suitability.
Must applicants have English as a first language?
Candidates whose first language is not English must demonstrate that their level of written and spoken English fluency will enable full participation in the programme. An IELTS (International English Language Testing System) certificate 6.5 overall would provide evidence of proficiency. A history of regulatory work output in English and in a UK-based company may be considered sufficient.
Can students with a disability access the programme?
TOPRA makes no distinctions in its admissions policy with regard to disability. Every reasonable effort will be made to supply students with services that meet their needs.
Do I have to decide at the outset which modules I wish to attend?
No, but you will need to indicate which module you want to take as your first module.
Should I start the programme with an overview module (7FHH1097 or 7FHH1151)?
You may start the programme at any module, however the admissions panel might require you to begin with the overview module most relevant for your pathway, or take it as one of your selected modules if they do not consider your relevant regulatory experience sufficient. The order in which you take the modules is your personal choice, dependent of course on when they are scheduled to run.
The first day of the first module you attend is the official start date of your enrolment on the programme.
Can I take modules on a single, free-standing basis without committing to the postgraduate programme?
While priority is given to registered students, participants take modules as standalone Masterclasses provided there is space on that particular course. There are no formal entry requirements for non-students, but delegates should be sufficiently experienced in order to contribute appropriately.
Masterclasses are a great option for professionals wishing to increase their knowledge of specific areas of regulatory affairs, without the need to pursue the additional studies required to pass the MSc.
Please note that if you take a module on a free-standing basis and do not join the MSc programme, you cannot later on join the MSc and gain credit for the module you took previously.
If I take a few modules on a free-standing basis and then decide to take the MSc, can previous modules contribute?
Ideally, students should decide before undertaking a module whether they want it to contribute towards the MSc. However, should you take a Masterclass and decide to enrol on the MSc, you will need to apply for a place on the programme immediately after the module – and undertake the written assessment for that particular course.
If you do not enrol immediately you cannot use modules you have taken in the past to gain a qualification.
What does studying for an MSc RA involve?
- Attending 8 modules
- Following up each module with private study and prepare a course journal and written assignment/s related to the subject of each module.
- Completing 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.
PN: Students can gain an interim award of a Postgraduate Certificate in Regulatory Affairs after completion of 4 modules; or a Postgraduate Diploma in Regulatory Affairs after the completion of 8 modules.
How much study will I really have to do?
Be prepared to work hard! At the modules, students are provided with a great deal of information that will act as baseline/guidance for further study. As with any postgraduate course it is then up to you to undertake self-directed learning in order to develop a wide breadth of knowledge relevant to your professional needs.
You will be expected to prepare appropriately for each module and to complete the course journal and written assignment/s within the deadline. This independent work takes around an additional 80 hours per module.
What is a course journal?
The course journal is prepared by collecting and analysing reference material relevant to the subject of the module, eg guidelines or published references.
Your ability to build up an information base in the form of a course journal is assessed for each module; you must demonstrate that you understand the significance of the information gathered, analyse and relate it to relevant areas of medicines, medical device development and/or regulatory practice. Understanding, interpretation and presentation of facts and arguments are tested by preparation of written assignments. One additional assignment for each module must be completed within three months of the course.
By the time you have participated in the module, researched the topic and satisfactorily completed the written assignment, you should have acquired an in-depth knowledge of the subject of the module.
The marks awarded for each element – course journal, written assignments and dissertation – are detailed in the Student Handbook, available on request from firstname.lastname@example.org.
How will I prepare for the dissertation?
The MSc dissertation is research-based. First you need to select a topic. It will need to be a regulatory-related subject that can be researched with the aim, like all research, of answering specific questions.
The regulatory field has many open questions, such as ‘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 merely 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 are asked to send in a research proposal to the Course Director, using the required application form. You will need to include a proposed title, research aims, methods and analysis, together with details of a proposed supervisor. The Examiners and Course Director will then determine if the proposal is acceptable or needs revision.
How will I be supported during the dissertation?
As part of your research proposal, you will have identified someone who can act as your project supervisor. In addition to their support, you will have up to 10 hours of support from an academic supervisor.
What else should I consider before enrolment?
Studying for the MSc RA requires a considerable commitment, both from yourself and from your employer. The additional study time on top of your attendance at the modules is described above. This information should help you decide if the course is the right one for you.
Make sure you read the Student Handbook before attending the initial module as it gives full details of the regulations governing the course together with relevant practical information. You will receive the handbook as soon as you are admitted to the course.
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