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May 14 2014 9:00AM - May 15 2014 5:30PM | Millennium Gloucester Hotel London Kensington
4-18 Harrington Gardens
It is now nearly two years since the implementation of the new EU PV legislation, and so it is time to reflect on the impact these changes have had on the role of the QPPV 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. The 2014 meeting aims to inform QPPVs about any challenges relating to the ongoing release of the new PV legislation by the EMA, alert them to what is coming down the pipe and provide recommendations on preparing and incorporating these changes into the daily life of the QPPV.
Session Topics Include:
Millennium Gloucester Hotel London KensingtonA limited number of rooms are available at a special rate. DIA rate is guaranteed until 31st March 2014, or until room block is filled. Attendees should make reservations as soon as possible.
To make your booking, go to www.millenniumhotels.co.uk/millenniumgloucester/Booking Code: LOND130514 (insert the code into the Enter Code box)Single GBP 145.00/Double GBP 155.00 including breakfast and VAT
Address: 4-18 Harrington Gardens, London SW7 4LH, UKTel: +44(0) 207 331 6105 Fax: +44(0) 207 331 6123
Travel InformationFor details on public transport please visit http://www.tfl.gov.uk
EU QPPVRoche Products Ltd, United Kingdom
Director, EU PV and DQPPVMerck Sharp & Dohme Ltd, United Kingdom
DirectorCastle Pharmacovigilance Ltd, United Kingdom
Chief Medical OfficerDanish Health and Medicines Authority, Denmark
QPPV and Head of Affiliate Vigilance ExcellenceAbbvie Ltd., United Kingdom
International Head GPV&E and EU QPPVBristol-Myers Squibb, United Kingdom
Principal Consultant Pharmacovigilance and Drug SafetyNDA Regulatory Science Ltd, United Kingdom
Director, Drug Safety EuropeSucampo AG, Switzerland
Room: Kensington Suite
As a result of feedback from previous years we are repeating this workshop aimed at those EU QPPVs who are new to the role, those who support the QPPV and those who are thinking of taking on a QPPV role. It can also act as a check-up for those who need it. The session will focus on providing an understanding of the QPPV role, the practical issues facing QPPVs in a range of company sizes and types, what skills and knowledge you need for the role, and legal considerations for QPPVs.
Click on View PDF to download programme details.
Session 1: Developing Areas – Risk Management and Minimisation
This session will provide a forum for discussing late breaking and hot topics in pharmacovigilance and risk management, with consideration of QPPV involvement or impact.
Session 3: Have the new EU PV regulations changed the role of the QPPV? Two years on – how different is the role? Regulator’s view
Session 4: Has the new EU PV regulations changed the role of the QPPV? 2 years’ on – how different is the role? Industry View
Session 5: Networking and Communications
Session 6: Operating as a QPPV in Different Companies
Although the degree of EU QPPV involvement in operational aspects varies according to company set-up, it is important to be at least aware of input on areas of practical challenge or interpretation in case of lack of regulatory clarity. Many long-term QPPVs are fond of saying “the devil is in the detail”. This session will aim to highlight such areas detected internally or via inspections, and examples of QPPV/MAH solutions towards maintaining compliance.
President Harry Truman once said “The buck stops here”'. And so it is with the EU QPPV who shall have sufficient authority to influence the performance of PV activities and the quality systems and to promote, maintain and improve compliance with the legal requirements of the MAH. What do we understand by ‘quality systems’ let alone how can we ‘influence’ and’ improve’ them? In this session we will examine latest thinking, best practices, the scope for interactions with QA organisations and give practical guidance for QPPVs to implement when they return back to their companies.
Group Discounts Available – Send 3 participants and the 4th is free!
Conditions apply. Online registration not available for group discounts. Call DIA in Europe on +41 61 225 51 51 or email for further information.