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.

Helen is a pharmacist working as a pharmacovigilance assessor at the Medicines Evaluation Board in the Netherlands. Besides assessment of Risk Management plans, signal procedures, and PSUSAs for the MEB, she is a member of Ephor. Ephor is the Expertisecentre Pharmacotherapy in Older people. For Ephor, she writes prescribing guides to improve appropriate prescribing to older patients.

Liana Martirosyan has been with Medicines Evaluation board since 2012 in the field of pharmacovigilance. Since 2008 she is the alternate PRAC member from the Netherlands. Liana is a medical doctor and holds MPH degree and PhD in pharmacoepidemiology. Special interests of Liana include interventions in clinical practice to minimize the drug safety risks and evaluation of additional risk minimization measures’ effectiveness.

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.

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.

Main roles and responsibilities are within the signal management activities in the EMA Pharmacovigilance Office; to conduct of ad-hoc queries and related data analyses based on requests from (Co)-Rapporteurs, EMA’s Scientific Committees and relevant Working Parties in the context of product related safety issues using EVDAS; to provide expert advice to EMA product teams on pharmacovigilance/signal detection and management issues; to support the implementation of the EV Access Policy and address requests related to access to information/documents from EV; to support the implementation of the Pharmacovigilance legislation. Rodrigo is co-chair of the EudraVigilance Expert Working Group.

Bart holds a Maste in Biomedical Science (Toxicology and Epidemiology) and a PhD in Medicine (Medical Microbiology). After working for several years in academia in (pharmaco)epidemiology, he is working in Pharmacovigilance for more than 25 years in several international positions in pharma industry (inc. Organon, MSD and Astellas). In UCB he is now leading the global PV team as well as being the EEA/UK Qualified Person for Pharmacovigilance. He is also representing UCB in the Efpia Pharmacovigilance Expert Group.

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.

Anita Volkers has been a pharmacovigilance assessor for more than 15 years at the Dutch Medicines Evaluation Board (MEB). She obtained a PhD degree in psychology/psychiatry and has been a researcher in the field of pharmacoepidemiology for several years since then. In the field of pharmacovigilance, she is all round experienced with a broad regulator perspective of risk minimization of adverse drug reactions and medication errors. Areas of special interest are the risk of dependence and addiction with pain medication and other CNS acting medicines, Pregnancy Prevention Programs (PPPs), enhanced digital access to (a)RMM, and post-marketing evaluation studies of the effectiveness of RMM including qualitative studies.

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.