EuroMEEting

thEME 4
Theme 4 | Pharmacovigilance
Vicki Edwards, Senior Director, European Pharmacovigilance, Abbott, UK
Jan Petracek, CEO, Director of Pharmacovigilance Services, Pharminvent,
Czech Republic
Some say that the new pharmacovigilance legislation represents the biggest
change in pharmaceutical legislation since 1995 – some say even longer.
The Pharmacovigilance Theme will look at the impact of these changes and
explore how both regulators and the industry are rising to the challenges of
implementation. The sessions will look at some of the more practical aspects
of implementation such as the Pharmacovigilance System Master File (PSMF)
but also explore the impact of some of the less tangible elements such as
transparency and communication issues. Additionally, the theme will look at
other advances in PV such as the IMI PROTECT initiative relating to benefit/risk
methodology and the use of new technologies.
session 0401 | Tuesday, 5 March 2013 | 09:00-10:30 | elicium 2
IMPLEMENTATION OF THE NEW PHARMACOVIGILANCE LEGISLATION
Session Chair:
Vicki Edwards, Senior Director, European Pharmacovigilance, Abbott, UK
Since July 2012, the step-by-step implementation of the new EU legislation
on pharmacovigilance has brought about the first operational experience in
meeting the new requirements for both regulatory authorities and industry.
Senior speakers representing the key players in the field will share their
experience and discuss with attendees their points of view on burning
questions the new reality brings.
A Regulator’s View of the Early Implementation of the New PV Legislation
Mick Foy, Group Manager, Medicines and Healthcare Products Regulatory
Agency (MHRA), UK
Update from the Innovative Pharma Industry
Laurent Auclert, EFPIA Observer, EU QPPV, Sanofi, France
Update from the Generic Pharma Industry
Maarten Van Baelen, Medical Affairs Manager, European Generic Medicines
Association (EGA), Belgium
session 0402 | Tuesday, 5 March 2013 | 11:00-12:30 | elicium 2
BEST PRACTICES IN PHARMACOVIGILANCE GOVERNANCE
Session Chair:
Jan-Willem Van der Velden, CEO, Mesama Consulting, Switzerland
Ever-increasing workload and limited resources create an unprecedented
pressure on effectiveness in performance of pharmacovigilance operations of
all players regulated by EU pharmaceutical law. Best practices in governance
are high on the agenda of all PV directors and leaders. Session speakers will
share their approaches, and discuss with participants various options meeting
some of the most resource intensive requirements.
The Growing Importance of Independent Adjudication for Post-Marketing
Studies
Donna Davison, Director, Medical Operations, INC Research, USA
How Can We Build Reliability and Quality when Outsourcing
Pharmacovigilance?
Brian Edwards, Principal Consultant Pharmacovigilance and Drug Safety, NDA
Group, UK
The Pharmacovigilance System Master File
Maria Wishart, Deputy EU QPPV, GlaxoSmithKline R&D Ltd, UK
27
session 0403 | Tuesday, 5 March 2013 | 14:00-15:30 | elicium 2
BENEFIT/RISK MANAGEMENT IN PHARMACOVIGILANCE
Session Chair:
Saad Shakir, Director, Drug Safety Research Unit, UK
Management of risks has been well established in the EU, and further
reinforced by the new EU legislation. In addition, new regulatory possibilities
allowing for more effective management of benefit have been created by
good pharmacovigilance guidelines. Session speakers will explore how they
have used these new options in their practice as academia, industry, and
regulatory authorities.
Risk Management PASS and PAES; the impact of the new legislation and the
way forward
Saad Shakir, Director, Drug Safety Research Unit, UK
Failure Modes, Effects and Criticality Analysis Techniques (FMECA) to
Optimise Benefit/Risk Management
Samuel Ramsden, Senior Safety Medical Writer, Novo Nordisk A/S, Denmark
Additional speaker invited - see EuroMeeting Extra for details
session 0405 | Wednesday, 6 March 2013 | 09:00-10:30 | elicium 2
NEW OPPORTUNITIES FOR INFORMATION TECHNOLOGY IN
PHARMACOVIGILANCE
Session Chair:
Maria Wishart, Deputy EU QPPV, GlaxoSmithKline R&D Ltd, UK
Use of computerised systems is critical for effective performance of all
pharmacovigilance operations. Quick development of new software,
implementation of new standards, and increasing deployment of electronic
exchange of information between the pharmacovigilance players create new
challenges, efficiency gains, and opportunities for errors. Speakers will guide
audience through some of the highlights in the latest development that may
change the way we do pharmacovigilance in the near future.
Social Media and Pharmacovigilance: Socialvigilance
Maria Vazquez-Gragg, Global Head, Safety and Pharmacovigilance, RTI
International - Health Solutions, USA
Adverse Drug Reaction (ADR) Reporting via Mobile Devices
Maiken Hedegaard, Life Science IT Consultant, NNIT A/S, Denmark
Online Patient Reporting of Adverse Events: A case study
Monica Plöen, Manager, Signal Detection and Analysis, Uppsala Monitoring
Centre, Sweden
session 0406 | Wednesday, 6 March 2013 | 11:00-12:30 | elicium 2
RISK COMMUNICATION AND TRANSPARENCY
Session Chair:
Angelika Joos, Director, Head Regulatory Policy, EU & Most of World, Merck
Sharp & Dohme (Europe) Inc., Belgium
Feedback to healthcare professionals and public about outcomes of
pharmacovigilance processes and assessments used to be a weak point
in Community Pharmacovigilance system. New EU legislation enables a
significant increase in transparency of regulatory authorities, sharing the
results of work done by industry. This includes safety web portals, central
assessment of risk communication documents by the Pharmacovigilance Risk