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.

Physician and pharmacovigilance leader with more than 26 years of experience as a senior regulator, QPPV, auditor, trainer, and serial entrepreneur. Working in intelligent automation in PV for over 10 years, with the last 4 years dedicated to hands-on development and implementation of generative AI and AI agents in PV operations, including the validation of such systems and their defence before auditors and inspectors. Faculty member of DIA’s AI in PV training course and lecturer at the European Course in Pharmaceutical Medicine. Fellow of the International Society of Pharmacovigilance. Educated at Charles University in Prague, Imperial College London, with additional executive education in business and agentic AI from Harvard and MIT.

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.