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.

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.

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.

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.