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Liz Hancox, Deputy EU QPPV for Pharma Products and Head of Safety Governance

GSK

Dr Elizabeth Hancox is Deputy EU QPPV for Pharma products and Head of Safety Governance at GSK. This includes day to day support for the QPPV model including the EU and increasingly local or regional QPPVs.
She has worked at GSK for 10 years in a variety of safety roles and has broad experience including materiovigilance and cosmetovigilance. 
Prior to joining GSK she worked for Clinical Research Organisations in the fields of clinical trials and pharmacovigilance. She has experience in both early and late phase clinical trials, signal management, audits and inspections and quality improvement.
Areas of interest include productivity, quality management and education including support for Pharmaceutical Medicine training for physicians.


Abstract

QP Challenges in Relation to Brexit
Exploration of challenges and opportunities arising from Brexit for large companies
 

Brexit challenges

This section will cover the management of uncertainty, working with stakeholders, and how to balance preparation and flexibility to maintain compliance in a complex internal and external environment.

Opportunities- Lessons from changing QPPV 
The focus of the section will be on lessons learned and how we are using these to inform our responses to the increasing complexity in QPPV and PSMF regulations globally.

Clarity on Accountability and oversight in a global model, balancing company and regulatory needs and ensuring clear documentation of the systems for oversight and escalation.

Opportunity to review model as GVP has been in place since 2012 and has undergone some changes.  Worked with stakeholders including local experts to include emerging local regulations in our review. Assessed current state and determined what data needed for PV system and EU QPPV oversight. Also what data is needed for other local / regional QPPV oversight and our oversight of their activities.

Key aspects include:

  • Routine reports and metrics
  • Types of data and scope of data for PSMF – EU vs UK and other country needs 
  • Communication and escalation
  • Visibility- metrics –and reporting to multiple authorities- consistency of messaging whilst taking into account local needs and impacts.

How to document change and decisions to ensure complex change is performed in an audit and inspection ready way.


 

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