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The end of the Brexit Transition Period – Impact on Pharmaceutical Industry Training Course
90 minute live webinar
14:00 (UK/London Time Zone)
27 Jan 2021
Details
The end of the transition period - are you prepared for the changes?
The UK has left the EU, and the transition period has now ended. This will have major implications for all aspects of Medicines Regulations in the UK.
During this 90 minute webinar, our expert speaker Dr David Jefferys will talk about the implications and the new opportunities that will arise, including:
- New International Collaborations
- The future requirements for Orphan applications and Paediatrics
- Batch Release and Compliance testing
- New Safety and PV arrangements
- Clinical Trial Controls in the UK
- The implications of the Northern Ireland Protocol
- The future arrangements for variations
- The conversion of current EU Centralised Authorisations into UK Licenses
- The new authorisation routes
- The legislative changes
The webinar will include a 45 minute presentation, followed by a discussion and Q&A session.
Programme
The end of the Brexit Transition Period – Impact on Pharmaceutical Industry
- Introduction
- New International Collaborations
- The future requirements for Orphan applications and Paediatrics
- Batch Release and Compliance testing
- New Safety and PV arrangements
- Clinical Trial Controls in the UK
- The implications of the Northern Ireland Protocol
- The future arrangements for variations
- The conversion of current EU Centralised Authorisations into UK Licenses
- The new authorisation routes
- The legislative changes
- Q&A and discussion session
Presenter
David Jefferys (More...)
Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices.
He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.
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27 Jan 2021 Live webinar |
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27 Jan 2021 Live webinar |
GBP 99.00 EUR 139.00 USD 154.00 + VAT @ 20.00% |
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