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.

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.

Dr Liana Martirosyan is a medical doctor with an MPH and a PhD in pharmacoepidemiology. She represents the Netherlands at the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and serves as its Vice-Chair. Liana joined the Medicines Evaluation Board (MEB) in 2012, where she worked as a pharmacovigilance assessor before becoming a PRAC member. Her special interests include interventions in clinical practice to minimise drug safety risks and the evaluation of the effectiveness of additional risk minimisation measures.

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.