Brexit is a major change to the regulatory landscape in Europe, offering both regulatory challenges to biopharma more recently accustomed to increased harmonisation and convergence, as well as some opportunities in the UK. With the UK leaving the EU on January 31st 2020, the new regulatory paradigm in the UK and EEA is emerging. This session charts the progress of negotiations and the risks and opportunities to companies. Like any good movie franchise it will seek to update the audience on what's happened to our main protagonists over the last 12 months. Without relying upon advanced action sequences with comic book heroes, or a big soundtrack, the session will detail changes to both the EU and UK regulatory spheres. Attendees will be brought up to date on how the EU have managed the departure of the UK and what has been the impact to their procedures and service offerings. In parallel, the session will provide a regulator view on the UK regulatory service offerings post Brexit and describe how MHRA will operate. Topics covered will include drug registration procedures post Brexit, early access schemes and scientific advice procedures available post Brexit, orphan drug designation, GMP certification and batch release site requirements, as well as how clinical trial applications are now handled in both regions.
Describe how strategic considerations for registering a new drug in the UK at the same time as an EMA centralised procedure.
List the UK regulatory service offerings post Brexit and describe how they will operate.
For EU licences, demonstrate how to ensure ongoing compliance with EMA requirements following the UK's departure.
Provide valuable lessons learned from the Brexit experience and opportunities to enhance future significant changes within your company.