Faculty
Kiki Cheung
Inspector, IGJ, Netherlands
Kiki Cheung works as a pharmacovigilance inspector at the Dutch Health and Youth Care inspectorate since 2013 after finishing her master in Epidemiology. Besides conducting inspections, she has also been involved in the development of a Risk-Based system for national inspections to effectively monitor the compliance of marketing authorisation holders.
Ineke Crijns
Senior Pharmacovigilance Assesor, Medicines Evaluation Board, Netherlands
Ineke Crijns is a medical doctor specialised in Pharmaceutical Medicine and PhD. After working as a resident / house officer in Obstetrics and Gynaecology, started working for a contract research organisation, followed by a position as medical adviser in pharmaceutical industry and working for the Dutch MEB as a senior assessor pharmacovigilance since 2000. During 2001-2009, she was (alternate) member of the Pharmacovigilance Working Party of the CHMP on behalf of the MEB.
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.
Remy Francisca
Pharmacovigilance Assessor, Medicines Evaluation Board, Netherlands
Remy Francisca is a medical doctor and pharmacoepidemiologist in training. After working as a resident/house officer in Internal Medicine in the Netherlands, he started a PhD in pharmacovigilance as well as working as a pharmacovigilance assessor at the Dutch MEB since 2015. His PhD project focuses on additional risk minimisation measures of medicines authorised in the EU.
Wendy Huisman, PharmD
VP Quality and Patient Safety, Avanzanite Bioscience, 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.
Maris Kuningas, PhD
Coordinating Specialist Pharmacovigilance Inspector, Dutch Health and Youth Care Inspectorate, Netherlands
Maris Kuningas has worked as a pharmacovigilance inspector at the Dutch Health and Youth Care Inspectorate since August 2011. Before joining IGJ, Maris worked as postdoctoral researcher at the department of Epidemiology in Rotterdam, the Netherlands. Maris has a PhD in genetic epidemiology from the Leiden University Medical Center, the Netherlands.
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
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.
Stephany Suoth
Pharmacovigilance assessor, Medicines Evaluation Board, Netherlands
Stéphany Suoth is a pharmacovigilance assessor at the Dutch national agency (MEB) since 2011, with deep interest in databases/Eudravigilance (EV) and in depth knowledge of signal and risk management procedures and operations. Next to assessment of post-marketing safety reports, she also participates the PhV business team and the EV Expert Working Group meetings. Prior to working at the MEB, she held different positions at the pharmaceutical industry with a portfolio of contraceptives and HRT for 7 years.
Paul ten Berg
Pharmacovigilance Assessor, Medicines Evaluation Board (MEB), Netherlands
Paul ten Berg is a medical doctor. After obtaining his PhD in Amsterdam, he performed translational research on biomarker discovery in liver toxicity in Edinburgh. At the same time, he followed postgraduate courses in public health, pharmacoepidemiology and pharmacovigilance in the UK. Since January 2018, he has been working as Pharmacovigilance assessor at Dutch Medicines Evaluation Board. One of his focus areas is signal detection management. He is also member of the 'Harmonisation of RMP (HaRP) in Europe’.
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.
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