When I was asked to help TOPRA out as
Interim Chief Executive, I hesitated, but only for a second. TOPRA has always been a very important organisation to me and I believe that it should be viewed this way by the world at large.
So what prompts me to make such a bold statement about a very specialised professional development organisation, focused on a few niche groups of people in the life-sciences community?
All of us will directly and indirectly have need of health services in our lifetime including proprietary prescription drugs, over-the-counter medicines, diagnostic tests, medical devices of all sorts, and increasingly digital tools which may help us navigate the health system or manage both acute and chronic conditions.
All of these products have contributed to staggering increases in life-expectancy and the management of formerly life-limiting diseases. All share a common characteristic of being highly regulated and this is for very good reason if the public and clinicians are to have confidence in their use.
The effective regulation of these products and their safe introduction is a function of some very complex sets of legislation and the people and institutions responsible for implementing the legislation, both literally and according to intent and spirit. Great legislation poorly applied is of very limited value and that is where TOPRA comes in.
I see TOPRA’s role as critical to the safe and effective use of medicines and devices because we have a mission to provide the education and training needed to supply the needs of all of those organisations involved in managing regulatory processes with competent and capable people.
Without well-trained and thoughtful people, medical products which are not acceptably safe can slip through the net and create patient safety events. Without those same people, emerging and transformative products do not become available in a timely manner and that has the result of unnecessary morbidity and mortality.
So TOPRA and the work of its community of
volunteers and staff are crucial to the services that you and your relatives will receive when you have cause to engage with the health system.
The role of TOPRA is to support regulatory affairs people from their early steps into the profession and, through career development, enable them to become seasoned and experienced professionals. TOPRA can help them with knowing what developments are around the corner and what they need to learn as part of a structured continued professional development programme (CPD).
This role extends further beyond that, as well. Emerging complex and potentially intractable issues need a forum for resolution and TOPRA is a place where widely drawn skills and experience can come together to think-through and suggest innovative ways to resolve complex challenges.
Central to these at the moment are managing complex combination products such as those involving drug, device and software elements; working through how AI and in-silico approaches to product development and deployment can be risk-managed; and the impact of real personalisation of therapies on regulatory processes originally designed for standardised products.
TOPRA has a hugely important role to deliver for the benefit of society as a whole, and that is why we are looking to develop forward-looking programmes which address the future needs of our members, patients and the public.