8th European Forum for Qualified Person for Pharmacovigilance

Millennium Gloucester Hotel, 4-18 Harrington Gardens, London
8th European Forum for Qualified Person for Pharmacovigilance image
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Event has ended
This event ended on Thursday 15th of May 2014
Admission
Member Industry Early-Bird:€1,220.00,
Member Industry:€1,420.00,
Non-member Industry:€1,550.00,
Academia/Charitable/Government Member: €710.00,
e/Government Non-member: €840.00,
Pre-Conference Wo
Location

Millennium Gloucester Hotel, 4-18 Harrington Gardens, London

Nearest Tube/Rail Stations
Gloucester Road 0.08 miles

It is now nearly two years since the implementation of the new EU Pharmacovigilance (PV) legislation, and so it is time to reflect on the impact these changes have had on the role of the Qualified Persons for Pharmacovigilance (QPPVs) and their position and relationship with Marketing Authorisation Holders and regulatory agencies. QPPVs face multiple challenges, and the 2014 meeting will provide insights from regulators as well as MAH management into the expectations these stakeholders have of the QPPV.

In addition, Good PV Guidelines are still evolving. Therefore it is vital to remain abreast of any changes likely to impact the QPPV’s essential role. Such changes may arise from updates to European requirements or outputs from evolving projects. However, how the QPPV operates is also influenced by regulatory authorities outside of the EEA (e.g. FDA) and from cross-regional initiatives such as ICH.

Key Topics Include:
Two years later – Impact of the new EU PV requirements on the QPPV role
Risk Minimisation – Medication beliefs and behaviours, EU requirements
Metrics and KPIs – Support for QPPV oversight
Networks and Communication – Sources of information for QPPVsBeing a QPPV in Different Environments (non EU companies, contract QPPVs etc.)
Quality Systems – Compliance with GVP Module 1
PV Inspections – What’s new and what’s old (but still being found…)
Operational Challenges; e.g. the PSMF, in place and meeting Regulator needs?

Speakers: Denmark, Abbvie, Margaret Walters Director & Deputy EU QPPV, Merck Sharp & Dohme Ltd, Peter De Veene EU QPPV, Roche Products Ltd, Elspeth McIntosh Director, Castle Pharmacovigilance Limited, Doris Stenver Chief Medical Officer, Danish Health and Medicines Authority, Vicki Edwards QPPV and Head of Affiliate Vigilance Excellence, Global Pharmacovigilance and Global Medical Services, Michael Richardson International Head of GPV&E and EU QPPV, Bristol-Myers Squibb Pharmaceuticals Ltd, Brian Edwards Principal Consultant, Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd, Natalia Kocankova Director Drug Safety Europe, EU QPPV, Sucampo AG, Sucampo Pharma Europe Ltd

Tags: Around Town

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