Faculty
Wendy Huisman, PharmD
Director, Vigifit, Netherlands
Over the past 25 years Wendy has been dedicated to pharmacovigilance. She has broad experience as EU QPPV for generic and innovative products in complex companies. She also has wealth of experience in lobbying and networking in trade associations/working groups. In her current role, Wendy provides pharmacovigilance support to Pharmaceutical Industry and SMEs (startups). She enjoys setting up the PV system and supports in the development of the PSMF with associated documents. Since 2020 Wendy is a trained professional in Transactional Analysis (TA). TA is a theory of human personality and social behavior. TA gives a wealth of options to work with challenges and changes in organisational and personal development.
Fakhredin Sayed Tabatabaei, MD, PhD
Senior Assessor, MEB, Netherlands
Fakhredin Sayed Tabatabaei is a medical doctor and epidemiologist, working as Senior Assessor Pharmacovigilance at the Dutch national agency (MEB) for more than 17 years. He is also the chairman of the CMDh HaRP Project (Harmonization of Risk Management Plan). Fakhredin was an active member of the European Pioneer Group drafting the electronic product information (ePI) Key Principles that is published in 2020, and he is currently involved in the ePI Pilot Project in the Netherlands. Besides, he is the MEB representative in the Gravitate Health project, and the Network Subject Matter Expert in the Product Management Services (PMS) project.
Jan Petracek, MD, MSc
CEO, Ivigee, 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.
Negar Babae
Pharmacovigilance Assessor, Medicines Evaluation Board, Netherlands
Negar Babae is biomedical scientist with a Masters degree in Drug Innovation from Utrecht University. She obtained her PhD degree in oncology, also at Utrecht University. She is a pharmacovigilance assessor at the Medicines Evaluation Board in the Netherlands. As a regulatory authority she has experiences in assessing Risk Management plans, pre-post approval study protocols, signal procedures, and PSUSAs. Within the MEB she is closely involved in collaboration with Patient Safety organization IVM/VMI and the pharmacovigilance centre Lareb in context of the signal management process. She is the chair of MEB-IVM/VMI consultations and vice-chair of MEB-Lareb consultations.
Evelyn Mulder-Olthof
Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands
Evelyn Olthof studied biomedical sciences and has a PhD in medicines. She works as an assessor at the pharmacovigilance department of the Dutch national agency (MEB) for 5 years, and has high experiences in signal detection and Eudravigilance data analysis.
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