BIA MHRA Conference Report 2018.pdf

The UK BioIndustry Association (BIA) and the Medicines and Healthcare products Regulatory Agency (MHRA) brought together experts from across the life sciences sector to discuss some hot topics and important developments through a series of presentations and panel discussions. Key themes for the day included the UK regulatory environment now and post Brexit, the accelerated access pathway for breakthrough therapies and technologies, drug device combinations and the importance of real world evidence in regulatory decision-making.

Sir Michael Rawlins, Chairman of Medicines and Healthcare products Regulatory Agency delivered the keynote address on accelerating access to innovative therapies and implementing the AAR recommendations under the Life Sciences Industrial Strategy.

The report brings together highlights from the day including perspectives from senior experts from across the sector including: MHRA the UK regulator, the National Institute for Biological Standards and Control (NIBSC), the Clinical Practice Research Datalink (CPRD), the Department of Health and Social Care, the National Institute for Health and Care Excellence (NICE), the Office for Life Sciences, notified bodies, the life science industry, research charities and patient organisations.