Pharmacovigilance Europe 2017

From Verify.Wiki
Jump to: navigation, search
QuickUpload1132 20170615160331.png
Pharmacovigilance Europe 2017
Date May 24-25, 2017
Place London, UK

With the mission of ensuring drug safety for better public health, the Pharmacovigilance Europe Congress 2017[1] took place this May in London, United Kingdom. This was an occasion for senior professionals from all over the world to gather again around current trends and developments in the field. Pharmacovigilance outsourcing, local pharmacovigilance compliance, and quality assurance were among the topics debated at this year’s edition.

Top Videos

Key Themes

  • Understand in depth the impact of PV legislation changes and trends of industries and their best practices
  • Assuring Compliance and its monitoring
  • Studying the role of QPPV and preparing for PV audit and inspections
  • Devising risk management plans, strategies and new risk-benefit analysis tools to improve REMS reporting
  • Implementing the risk management plans as well as safety surveillance methodologies for medical devices
  • Finding new approaches for risk minimization and communication
  • Formulating effective ways to enhance transparency and to encourage involvement of patients
  • Analyzing the IT and Social media role in Pharmacovigilance and Adverse events reporting
  • Assessing the use of databases and emerging tools for generation and detection of safety signals
  • Understanding the significance of outsourcing and its effectiveness
  • Finding new methods to promote harmonization of regulatory framework- developed and emerging markets

Key Speakers (2017)[1]

  • Jonathan Seltzer - President, ACI Clinical, USA
  • Benedicte Lunddahl - Team Leader Special Advisor, Danish Medicines Agency, Denmark
  • Dr. Tatjana Ajhler Duretek - Head of Medical Affairs and Pharmacovigilance, Belupo Pharmaceuticals
  • Chetan Shatapathy - Director and Medical Advisor, Sanjeevani Pharmaceuticals
  • Mircea Ciuca - Head Medical and Clinical Drug Safety, Vifor Pharma, Switzerland
  • Dr. Pipasha Biswas - Director and QPPV Pharmacovigilance and Pharmacoepidemiology, Symogen, UK
  • Giovanni Furlan - EU QPPV Helsinn Birex, Ireland
  • Nawab Qizilbash - Clinical Epidemiologist and Head of OXON PUK
  • Dr. Paul Tunnah - CEO Pharmaphorum
  • Prof. Saad Shakir - Director, Drug Safety Research Unit
  • Jorgen Matz - Senior Director Global Pharmacovigilance Risk Management, Lundbeck
  • Dr. Heike Schoepper - Head Global Drug Safety Regions Merck Serono, A Division of Merck, Germany
  • Jackie Roberts - Executive Director for Regulatory, Pharmacovigilance and Medical, UK Actavis
  • Dr. Shelley Gandhi - Director Pharmacovigilance and Drug Safety, NDA Group AB, UK
  • Julia Appelskog - QPPV and Head of Pharmacovigilance Department, Bluefish Pharmaceuticals Group, Sweden
  • Francoise Sillan - QPPV Sanofi, France
  • Catherine Akers - Senior Regulatory Affairs Manager, Amgen
  • Miranda Dollen - Vice President of Pharmacovigilance, MAPI Group


Pharmacovigilance(PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. Pharmacovigilance outsourcing was in the focus, with several presentations tackling good standards and practices. Some of the ideas voiced by speakers were related to the importance of having an in-house pharmacovigilance expert, as well as the challenges that might occur when costs are the ultimate goal of outsourcing activities. Risk management was also covered. Among the speakers who approached the topic, Drug Safety Research Unit’s Prof. Dr. Saad Shakir reviewed a series of studies for risk management and monitoring effectiveness of risk minimization. New trends in data acquisition and evaluation featured along other “hot” topics. Moreover, RPM’s Dr. Jackie Roberts provided a change in perspective, with the views of local affiliates on pharmacovigilance compliance.

Lectures were also complemented by panel discussions. First panel – gathering representatives of pharmaceutical companies – focused on PRAC strategy on measuring the impact of pharmacovigilance activities. The second panel was dedicated to patient support programmes, medication errors, and off-label usage.[2]


  1. 1.0 1.1

Verification history