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Virtual Event

2020年11月02日 (月) 午後 1:00 - 2020年11月04日 (水) 午後 4:25

(Central Europe Standard Time)

4051 Basel, Switzerland

Pharmacovigilance Strategies Workshop

Session 7: Post-Authorisation Safety Studies and Registries

Session Chair(s)

Bianca  Mulder, PharmD, MPharm, MSc

Bianca Mulder, PharmD, MPharm, MSc

Pharmacovigilance Assessor

Medicines Evaluation Board, Netherlands

Post authorisation safety studies and registries can provide valuable information on the safety of a medicinal product. The information from these studies and registries is used to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making. This session will be dedicated to current developments and challenges with regard to these studies and registries. There will be perspectives from Industry, the EMA and the NL regulatory agency.

Speaker(s)

Bianca  Mulder, PharmD, MPharm, MSc

Post Authorisation Studies and Implementation of Results

Bianca Mulder, PharmD, MPharm, MSc

Medicines Evaluation Board, Netherlands

Pharmacovigilance Assessor

Ulka  Campbell

The Impact of Non-Europeans PAS on PV systems in Europe and Globally

Ulka Campbell

Pfizer, United States

Senior Director, Epidemiology

Valerie  Strassmann, PhD, RPh

The Potential of Patient Disease Registries

Valerie Strassmann, PhD, RPh

European Medicines Agency (EMA), Netherlands

Scientific Administrator, Data Analytics and Methods Task Force

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