Webinar | Expert Roundtable: QP Perspective On Brexit

Date: Tuesday, June 19, 2018
Time: 9am EDT | 6am PDT | 2pm BST | 3pm CEST 

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With Phase 1 negotiations for the UK’s exit from the European Union complete, examining how well prepared your clinical supply operations are to ensure continuity of supply post-Brexit is highly advisable. Brexit preparation is not just for sponsors with studies already underway in the UK and EU.

Sponsors planning future studies in these regions can benefit from early evaluation and supply chain planning as well. One of the aspects of clinical supply most likely to be significantly impacted by Brexit centers around the Qualified Person batch certification of supplies that need to traverse from the UK to the EU and vice-versa. 

In this webinar, we will explore how Brexit may change the working relationship between Qualified Persons (QPs) in the UK, EU and beyond through a moderated Q&A roundtable. QPs from the UK and EU will exchange ideas and discuss in a how they will work together including what processes will be necessary and what their requirements from the other would be post-Brexit, based on the progress of current political discussions between UK and the European Commission whose impact on the resulting relationships between UK and EU is not yet predictable. 

This webinar is a rare opportunity to hear first-hand how the challenges around quality may be addressed from the very professionals responsible for upholding these quality standards, considering different post-Brexit scenarios. 

Moderating the webinar will be Rebecca Stanbrook, ISPE EU IP Steering Committee member and Global Head Compliance and Regulatory Affairs Quality, Novartis AG. 

Key Learning Objectives:

  • Understand current state of Brexit negotiations and the possible impact of various scenarios on the movement of clinical supplies between the UK and EU
  • Explore the current and potential future working relationship between UK and EU based QPs
  • Explore potential challenges and practical solutions to uphold quality standards post-Brexit

Presented by:

Moderator: Rebecca Stanbrook
ISPE EU IP Steering Committee Member
Global Head, Compliance and Regulatory Affairs Quality, Global Drug Development Quality
Novartis AG

Lynne Byers
Executive Director
NSF Pharma Biotech 

Pete Young
Director, Quality & Qualified Person (UK)
Catalent Pharma Solutions

Susanne Mehlhorn
Clinical Quality Batch Processing Manager & Qualified Person (DE)
Catalent Pharma Solutions

Register Today