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Park Plaza Amsterdam Airport

May 16, 2019 8:00 AM - May 16, 2019 4:00 PM

Melbournestraat 1, 1175 RM Lijnden, Netherlands

Signal Management

Module 3 of the MEB/DIA Excellence in Pharmacovigilance training course focuses on approaches to signal detection using quantitative methods illustrated in a workshop with examples as well as general considerations on signal management in the EEA.

Faculty

Bianca  Mulder, PharmD, MPharm, MSc

Bianca Mulder, PharmD, MPharm, MSc

Pharmacovigilance Assessor, Medicines Evaluation Board, Netherlands

Bianca Mulder is a pharmacist with a PhD in pharmacoepidemiology. Her research focused on the use of medication during pregnancy and the development of atopic diseases in children. She worked briefly in a pharmacovigilance position at a pharmaceutical company before she started working as a pharmacovigilance assessor at the Dutch national agency (MEB) in 2016.

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, iVigee Services a.s., Czech Republic

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

Pharmacovigilance Expert, GLD, France

Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Dr. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.

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