1-Day Course: The Impact of Brexit on Pharma & Medical Device Industries (London\, United Kingdom - March 18\, 2019) - ResearchAndMarkets.com

1-Day Course: The Impact of Brexit on Pharma & Medical Device Industries (London, United Kingdom - March 18, 2019) - ResearchAndMarkets.com

DUBLIN--()--The "Impact of Brexit on the Pharma & Medical Device Industries" conference has been added to ResearchAndMarkets.com's offering.

With Britain's exit from the European Union fast approaching, the new arrangements for all aspects of the regulation of pharmaceuticals, medical devices and IVDs between the UK and EU 27 pose major challenges. The ramifications of Brexit after more than 40 years of ever-deepening integration and alignment across the life science sector will be immense, whatever final form Brexit takes.

Hear the latest information from our expert speaker panel to help you understand the changes that are required and ensure you are up to date with Brexit!

This course will enable you to hear the latest information from our expert panel of speakers to help you understand the changes that are required and ensure you are ready as the deadlines approach.

Agenda

Brexit - the MHRA perspective

  • Where are we now?
  • What are the outstanding Issues?
  • What will happen next?

Question and answer session

The medical technology sector - what are the issues and how to operate from 30/3/19

  • How Brexit will impact on the implementation of the Medical Device Regulation and the IVD Regulation
  • Impact for existing and new products
  • Impact on the redesignation of Notified Bodies and of products under the new legislation
  • Position of UK-based Authorised Representatives Philip Brown, ABHI

Panel discussion

The pharma sector - what actions need to be taken to prepare for Brexit

  • The alignment for the approval of new products and changes and variations to existing products
  • The supply chain concerns, product release and batch testing
  • Transfer of market authorisations for UK authorised products
  • Issues where the UK is rapporteur/co-rapporteur - Reference Member State (RMS )
  • Position for orphan drugs, paediatrics requirements, exclusivity and intellectual property
  • Pharmacovigilance issues including location of the QPPV
  • Future clinical trial controls David Jefferys, Eisai

How to operate in the UK post Brexit

  • What will the key issues be?

Final discussion session

For more information about this conference visit https://www.researchandmarkets.com/research/cb3xkv/1day_course_the?w=4