How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
Social media, Zoom or Teams have proven to be very useful tools to get in touch with the patients, and one thing is clear – the future of pharmacovigilance is technology!
Over the pandemic in my company we have used social media as a tool to reach the public, giving updates on what we are doing to ensure robust supply of product and corporate social responsibility activities.
In pharmacovigilance we have had to arrange virtual, rather than team meetings, with patient groups using tools such as Zoom and Teams.
Brexit, and the ramifications of this with differing (and changing) requirements from the MHRA versus the EMA has certainly caused a few headaches, with the goalposts changing frequently and having to adapt a pragmatic and flexible approach. However, of course, regardless in any changes of processes or procedures, the ultimate goal always is to prioritise the safety of our products for our patients.
I think the digital revolution is only just kicking off and pharmacovigilance has some way to go to catch up with it. At the moment my company mainly uses people for all activity, but I do think, as the proliferation of data from apps and social media sites increases, we will need to find better ways of working, introducing more automation, to help identify those really important safety messages amongst all the noise. So I see the future involving a lot more technology. I also think the guidelines will need to evolve to keep up with the changing digital landscape.
Jackie Roberts is a scientist with a PhD in Clinical Pharmacology from Imperial College, London. She also has a business background with an MBA from Warwick Business School. Currently she works as the UK-QPPV at Accord Healthcare and is the Associate Vice President in Scientific Affairs Governance. Her prior experience spans regulatory affairs, project management and medical research. As well as industry she has worked at the UK regulatory authority, Contract Research Organisations, the UK NHS where she was a Director of a district hospital and in academia.