Regulatory affairs officer : Training

Professional training is available through The Organisation for Professionals in Regulatory Affairs (TOPRA) , including a diploma and MSc in Regulatory Affairs (for those with a minimum of approximately two years’ experience), validated by the University of Wales, and a diploma and MSc in Medical Technology Regulatory Affairs at Cranfield University. The courses, which are part-time, are aimed to meet the needs of professionals working in the field of regulatory affairs in the pharmaceutical and related industries.

Students must first complete the diploma course and then add a research-based dissertation to qualify for the MSc. Some stand-alone modules can also be studied for continuing professional development (CPD). Study at this level is becoming an important asset for progression, but as yet it is not a formal professional requirement.

Keeping up to date with developments in scientific research and development and regulatory matters is a key aspect of all regulatory affairs roles. As well as special events and conferences, TOPRA provides continuing professional development (CPD) opportunities through its CRED programme. This offers one-day workshops covering areas such as:

• European regulatory procedures;
• developing product labelling and patient information leaflets;
• biotechnology products.

TOPRA also offers CPD opportunities through e-learning and there are currently modules in negotiation and project management. New modules in leadership and managing high performance teams will be available soon.

In-house training opportunities vary between employers; some professionals may receive training and support from a more experienced colleague.