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Holiday Inn Amsterdam - Arena Towers

Nov 06, 2019 8:00 AM - Nov 07, 2019 4:30 PM

Hoogoorddreef 66a, 1101 BE Amsterdam, Netherlands

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

Networking your path to success amongst a World-class community

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Session 1: Future of Pharmacovigilance – Impact of Globalisation

Session Chair(s)

Doris Irene Stenver, MD, MPA

Doris Irene Stenver, MD, MPA

Independent Pharmacovigilance Adviser, Unique Advice, Denmark

In this session key EU regulators will provide an update of current activities at the level of EMA and PRAC, 8 months after re-location to the Netherlands and 7 years after the creation of the PRAC. How far is EMA with regard to regaining the momentum in further developing pharmacovigilance, after years with need for strict prioritization to safeguard the core business? How does increasing globalization impact the Agency´s strategies? Which are the major achievements of the PRAC? And how does the future look like in a PRAC perspective? This session will also include an update on the WHO Pharmacovigilance System and activities to strengthen pharmacovigilance in low and middle income countries, linkages with the WHO global benchmarking activities and institutional development plans for regulatory agencies.

Speaker(s)

Peter Richard Arlett, MD, FFPM, FRCP

Peter Richard Arlett, MD, FFPM, FRCP

Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

Data and Evidence to Support Benefit Risk Decisions

Sabine Straus, MD, PHD, MSC

Sabine Straus, MD, PHD, MSC

Former PRAC Chair, Medicines Evaluation Board (MEB), Netherlands

Future of PRAC

Shanthi Pal, DRSC, MPHARM

Shanthi Pal, DRSC, MPHARM

Group Lead, Medicines Safety, Safety & Vigilance, WHO, Switzerland

Pharmacovigilance Systems Strengthening – WHO Perspective

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