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May 14 2014 9:00AM - May 15 2014 5:30PM | Millennium Gloucester Hotel London Kensington
4-18 Harrington Gardens
Please note that the Pre-Conference Workshop is SOLD OUT! There is a waiting list available. For more information contact firstname.lastname@example.org.
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:
Continuing EducationDIA meetings and training courses are approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available on request from the DIA registration desk.
The QPPV Forum has been awarded with 15 CPD credits from the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians (RCP) of the UK. Medical practitioners who are eligible for credits can click on http://www.fpm.org.uk/cpd/registration for more information. If you are already a CPD member, please go directly to http://cpd.fpm.org.uk to claim your credits. Certificates are available on request from the DIA registration desk.
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.
Risk management and mitigation is a rapidly evolving area. Risk management plans have been around for many years and contain the important identified and potential risk for a given product and how the MAH proposes to manage these risks to optimise the benefit for the patients. In recent months, the EMA published the final guideline on measuring effectiveness of risk minimisation activities. As it is also important in the risk management cycle to continuously quantify the risk and communicate risks appropriately to the public, this session will also explore these elements of risk management and mitigation.
The pharmacovigilance legislation, which came into force in 2012, is highly innovative. The new legislative framework paved the way for significant changes in how we perform and organise Pharmacovigilance in the EU network. One major aim of the new legislation has been to clarify the roles and responsibilities of different stakeholders. This session will focus on how and to which extent the legislation has changed the role of the QPPV. Three different perspectives will be presented – expectations of the PRAC and of a national regulatory authority to the QPPV, followed by an inspectors view.
The new PV legislation which came into effect mid 2012 changed the drug safety environment in its scope and impact on reporting and evaluating information. Safety came to the centre of benefit risk and the role of the safety function with it. How did this impact the role of the QPPV within MAHs and externally with agencies? We will hear from regulators in session 3 and in this session from an industry perspective.
This session will explore the importance of appropriate networking and communication to the success of a QPPV. We will hear about how a new QPPV established his communication networks and the value he places on them. We will also look at the role of QPPV through the lens of a journalist and examine how the public may see the role. The session will also explore current approaches to communication with HCPs, patients and consumers and look at how the QPPV should be involved.
The scope of the role of EU QPPV is clearly defined in the EU legislation. In this session you will have the opportunity to learn how roles and priorities of EU QPPVs may differ in different types of companies and different cultural environments. The session will convey practical experience of EU QPPVs providing services for contract and small companies; you will learn what the daily challenges for EU QPPVs from generics companies are, and you will get an overview of the role of EU QPPV focusing on cultural differences.
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.