K E E P I N G
Y O U
MAY 2013
THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH
In this issue... Healthcare regulatory affairs is often perceived as a niche specialty, but actually it is a vast subject. Therefore, as a regulatory professional it is vital to build up a network of colleagues and connections because, guess what, no one individual can know it all! It is often more important to know where to find the information, or who to contact, rather than expecting to have all the answers. It’s great to see that the MSc in Regulatory Affairs is to continue with the support of the University of Hertfordshire, which goes to show that regulatory affairs is a career choice. With the TOPRA Awards not so far away now, this is your chance to nominate one of your colleagues who you think has that special quality about them which should be recognised. It’s also everyone’s opportunity to raise the profile of our profession. Talking about that ‘special quality’, thank you, Virginia, for being a great co-editor (see back page) – let’s stay connected. Greer Deal, co-editor
Validating relationships A message from Patrizia Nestby, TOPRA President
A pivotal role for TOPRA, as a professional membership organisation, is to provide high-quality education for its members, which is particularly important given the dynamic nature of the regulatory arena. In addition to the well-known introductory and other continuing professional development courses, TOPRA has a long history of successfully delivering two MSc courses. These Masters’ degrees are internationally recognised and are validated by partner institutions: the MSc in Regulatory Affairs was validated by the University of Wales; and the MSc in Medical Technology is validated by Cranfield University. At the beginning of my regulatory career, I completed the MSc in Regulatory Affairs and found it both inspiring and an invaluable foundation for my further development. It introduced every facet of regulatory affairs from a scientific, legal and commercial perspective. Personally and professionally, I can do nothing but advocate this Masters’ degree not only for our members but for their companies who will undoubtedly reap the benefits this course affords. In October 2011, the University of Wales announced it would no longer be validating any external institutions, including TOPRA. To ensure the long-term continuity of the TOPRA MSc, the TOPRA Board decided that this was an ideal opportunity to further develop the MSc by validating with another institution that would provide
even greater commitment to high-quality regulatory education working with TOPRA.
Exciting transition
The TOPRA office undertook a great deal of activity to select a suitable validating institution. I am very pleased to announce that as a result of all this hard work, the TOPRA MSc in Regulatory Affairs will now be validated by the University of Hertfordshire (see Box). This university is one of the UK’s leading business-facing universities. TOPRA will soon
release more information to existing and new students about this exciting transition. I would like to take this opportunity to thank the TOPRA staff for all their efforts to establish a relationship with such a highly respected validating institution, thereby ensuring the continuation of the MSc. I am convinced that this new relationship will offer the opportunity of a fresh start and will further evolve formal education provision in regulatory affairs.
Announcement MSc in Regulatory Affairs is now validated by the University of Hertfordshire. The University of Hertfordshire is one of the UK’s leading business-facing universities. It was awarded ‘Entrepreneurial University of the Year 2010’ by the Times Higher Education (THE) magazine. TOPRA’s successful modular Masters in Regulatory Affairs has been offered since 1989 and has seen more than 200 students graduate so far. The transfer to the University of Hertfordshire will ensure the long-term continuity of the TOPRA MSc to both new and existing students. Neil Fisher, TOPRA’s Director of Education and Training, said: ‘To be able to continue to offer our MSc with a high quality and well-respected institution means that this MSc qualification will continue to be regarded internationally as a relevant and high-quality award.’ The TOPRA MSc will be managed within Pharmacy, a department in the School of Life and Medical Sciences at the University of Hertfordshire. Benefits of partnering with this university include: ● Excellent library facilities ● Close links with leading pharmaceutical companies ● Other prestigious pharmaceutical courses are also validated, including an MSc in Pharmacovigilance.