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.

Mark Bailey has worked in a variety of industry pharmacovigilance roles for the last 18 years. He has been with Amgen since 2009 and in his current position since 2018. He has oversight of the writing of periodic aggregate safety reports, including DSURs and PBRER/PSURs with the responsibility for all report authoring processes, from scheduling to authoring to submission. He has experience in a range of therapeutic areas and pharmacovigilance activities and has been involved in many regulatory inspections.

Stephanie is an expert in Pharmacovigilance and Quality with over 20 years experience working alongside the leaders within the pharma industry. She is passionate about pharmacovigilance, compliance and supporting companies with the establishment of strong processes. Her experience includes inspection readiness activities, auditing and the review of pharmacovigilance systems.

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.

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.

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’.

Marian Verbruggen has broad experience in the field of pharmacovigilance as a pharmacovigilance professional in the generic industry since 2008 and has obtained a MSc in pharmacovigilance in Hertfordshire in the UK. She joined the Dutch Health and Youth Care Inspectorate as a Senior Pharmacovigilance Inspector in 2022.

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.