After obtaining a MSc in Drug Discovery and Safety at the VU Amsterdam, Pieter started working in pharmacovigilance in 2010. He worked as Drug Safety Officer and Senior Safety Scientist for different pharmaceutical companies and NGOs, specializing in Argus configuration and international legislation before he became Manager Affiliate Governance at the QPPV office at Incyte Biosciences in Lausanne, Switzerland. In 2019 he accepted a position as Senior Inspector Pharmacovigilance at the Dutch Health and Youth Care Inspectorate, performing national and EMA inspections.

Aurélia has 12 years of experience in Pharmacovigilance at the Pharmaceutical industry. As deputy QPPV and head of the Safety Data Analysis department at Synthon B.V. she was responsible for a variety of pre and post-authorization pharmacovigilance activities mainly case and signal management, aggregate reports and risk management plans. In 2019, she started her carrier as Senior Inspector Pharmacovigilance at the Dutch Health and Youth Care Inspectorate, where she performs national and EMA inspections.

Camelia has 15 years of experience working in academia, the pharmaceutical industry and in a regulatory agency, in the fields of regulatory affairs, pharmacovigilance and clinical trials. She is a pharmacist by education and has been working at the European Medicines Agency for almost 5 years. In her role Camelia is responsible for the coordination of GCP and pharmacovigilance inspections, taking part in drafting EU guidelines related to GCP and collaborating with international regulatory agencies on inspectional matters. Camelia has a PhD in Pharmaceutical Sciences.

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.

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.

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.

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. As of July 2012 she is the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

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’.

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.

Inge Zomerdijk has been in the pharmacovigilance department of MEB since 2010. A senior pharmacovigilance assessor and as a regulator has experiences in assessing Risk Management Plans, study protocols and results of evaluations of risk minimisation measures, national implementation of risk minimization measures as well as benefit-risk assessments of both new drug applications or post marketing follow up. In 2015 she completed her PhD research at the Erasmus Medical Center, focusing on how to evaluate risk minimization measures, the impact of these measures on the benefit-risk balance of drugs and translating possibilities and challenges to practical implications for regulatory authorities and industry and remains involved in research.

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 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.