- This event has passed.
3rd Annual Pharmacovigilance Forum
September 17, 2015 - September 18, 2015
– Vienna, Austria
Visionary pharmacovigilance experts across the world are eager to develop a new global network, to share benefit and risk based intelligence of medicinal products. With the fast spread of globalisation, cross-borders & trade-blocs, medical practitioners and drug manufacturers are force to adopting holistic strategies to battle the increasing pressure from their stake holders. The humble aim of GLC’s 3rd Annual Pharmacovigilance Forum, is to provide a platform for these practitioners in the hope of finding the answers to some of the pressing issues they face nowadays.
Be the first to uncover the first experiences of complete transition from DDPS to PSMF. Listen to industry experts discussing ready-made and tested solutions to transparency issues in ADR. Discover the correct directions, to adhere to upcoming regulatory deadlines, discussed by its creators, if not by its supporters. Witness the highlight of the event, a participative workshop providing practical insights to overcome inefficiencies and redundancies in PV processes. Meet and greet 20+ industry specialists from global conglomerates such as, Novartis, Pfizer, Abbott, Astellas, Takeda and other experts from the European Medicines Agency, The Royal College of Physicians, and the Drug Safety Research Unit surrounded by a selected senior audience from across Europe.
Coupled with a diversified set of thought leaders and a five star environment, this one of a kind symposium, will link drug manufacturers with the medical practitioners, academia’s, PV related associations and governmental representatives from across Europe under one roof.Without a doubt, an exclusive gathering within the PV event space, you cannot afford not to capitalise upon.
- Regulatory overview of the past year and forecast for 2015
- Essential updates on the current situation of PRAC
- Understanding regulatory requirements for the Pharmacovigilance System Master File (PSMF)
- Solutions to Improve and maintain Pharmacovigilance System Master File (PSMF) in practice
- Principles of the Risk Management Plan and best practice in risk mitigation
- Advantages and disadvantages of outsourcing in the pharmaceutical industry
- Emerging IT Solutions to enhance Pharmacovigilance System
- Investigate what is required for a Post-Authorisation Safety Studies (PASS) and Post- Authorisation Efficacy Studies (PAES)
- Pitfalls of ADR data collection and management
- Adaption of real World Evidence in Pharmacovigilance and Drug Safety
- Challenges of the recently launched Black Triangle Symbol
- General principles of writing and submitting Periodic Safety Update Reports (PSUR)
- Strategies to overcome the challenges of Qualified Person for Pharmacovigilance (QPPV)
- Investigate the impact of the new EU requirement on QPPV role
- Key issue: communication with the patients
- Path of challenges towards the optimal signal detection
- Importance of monitoring in the industry
Contact person: Lara Ventoso [firstname.lastname@example.org]Conference Manager