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Congress Center Basel

2018 年 04 月 16 日 2:00 下午 - 2018 年 04 月 16 日 5:30 下午

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

Hot Topics in Pharmacovigilance

Instructors

Sabine  Brosch, PharmD, PhD, MPharm

Sabine Brosch, PharmD, PhD, MPharm

Data Protection Officer, European Medicines Agency, Netherlands

Sabine Brosch was appointed DPO at EMA in January 2022. She joined EMA in 1996 and has been working in pharmacovigilance, clinical trials and international harmonisation (ICH) and standardisation (ISO) focusing on the development of the Individual Case Safety Report and Identification of Medicinal Products standards as well as the medical terminology MedDRA. She holds a master’s degree in pharmacy and a doctor of natural sciences degree of the University of Vienna, Austria.

Anja  Van Haren, MSc

Anja Van Haren, MSc

Eudravigilance coordinator, Medicines Evaluation Board (MEB), Netherlands

Anja van Haren holds a Master in Health Policy and Management from the Erasmus University in Rotterdam. Her career at the Medicines Evaluation Board (MEB) in the Netherlands started in 1998 as a Pharmacovigilance assessor. Since 2004 she has been responsible for technical and procedural aspects of expedited Adverse Drug Reaction reporting in pharmacovigilance. In her current position at the MEB as EudraVigilance Coordinator the focus of her work is on ADR reports, signal detection and signal management. Anja is co-chair of the EudraVigilance Expert Working Group, co-chair of the Pharmacovigilance Business Team and representative of the EU in the ICH E2B(R3) and ICH E2D(R1) Expert Working Groups.

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