Brexit Roundtable: New MAAs and Lifecycle Maintenance

Brexit Roundtable: New MAAs and Lifecycle Maintenance
Pharmaceutical New Product Applications and MA Lifecycle Management - The Clock is ticking. Should alarm bells be ringing? This is the second in a series of three Roundtable meetings to help our members prepare for Brexit. Focused on the biggest challenges for regulatory professionals, the meetings offer an opportunity to discuss the latest information and solutions for the many challenges you face.


Brexit Roundtable:  On Friday 29th March 2019, the UK and Northern Ireland will leave the European Union.  The clock is ticking and yet very little seems to be clear!

 

 



When: 14 June 2018, 13.30-18.30
 Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom 




The point of view from pertinent stakeholders followed by workshop and a panel discussion about your perspectives and open questions ready for “B-Day” and beyond.



What is it
  • Less than 10 months to go before the UK leaves the EU Community
  • Detail of transition agreement unclear, and thought likely that details will be under negotiation “to the wire” until finalised at the end of June.  
  • It is increasingly considered that the terms for the UK withdrawal agreement, which will be subject to negotiation until Q3 this year, will not be as accommodating as hoped, and therefore companies that currently rely on the UK for EU regulatory support need to have completed their pre-Brexit preparations before the trap door closes effectively in January 2019.
  • UK progressively being written out as a significant partner in the EU network for healthcare product regulation (e.g. no longer selected for rapporteur/ co-rapportership in CPs, less participation in key NCA/ EMA meetings)
  • It is possible that under the transition arrangement, the QPPV/ Deputy QPPV and finished product batch release could continue to be located in the UK, but affected companies are advised not to take this to chance.
  • So what will the MHRA do to deal with all the changes that will occur post-Brexit, and at the same time not lose significant ground in its aspiration to remain a world leader in healthcare product regulation?


Speakers include:

David Jefferys, Eisai
Mike Murray, ABPI
Louise Gill, GSK
Alison Dennis, FieldFisher




How do I apply? 
Online registration is now closed. To book, please email meetings@topra.org or call +44(0)20 7510 2560.

Course fees:
Type Member  Non-member 
Standard                   £150+VAT                 £250+VAT                          

 

Terms and conditions 
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.




Brexit Roundtable: Clinical Development
The next Brexit Roundtable will take place on 19 July.  For further details please see:

www.topra.org/rtjuly2018

 

When
14/06/2018 13:30 - 18:30
Where
TOPRA 6th Floor 3 Harbour Exchange Square London E14 9GE UNITED KINGDOM
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