Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

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.

Chia Yin is currently the Patient Safety Partner and Risk Management Plan Implementation Coordinator in Roche. Chia Yin’s responsibilities include maintaining oversight and ensuring effective implementation of safety risk management strategy. Chia Yin brings experience from the APAC region as she was the Drug Safety Manager in Roche Malaysia, holding the roles as a deputy Local Safety Responsible and RMP IC since 2018. Chia Yin continues to share her passion in the area of pharmacovigilance seeking opportunities in partnering across different functions to advance the impact of pharmacovigilance towards the safe use of medicines. Chia Yin is a pharmacist by training with clinical experiences in primary to tertiary healthcare settings.

Omar Aimer has more than 19 years of experience in Drug and Device Safety , Quality Assurance and Risk Management in the Pharmaceutical Industry, regulatory authority and Hospital environment in Europe and North America. Omar is an Executive Committee member of the International Society of Pharmacovigilance (ISoP) and Leader of the Medical Device Safety – Special Interest Group (SIG). He has presented in multiple scientific forums and contribute in several per reviewed publications with interest in new technologies, regulation, medical devices, combination products and ATMPs as well as the improvement of pharmacovigilance around the world (LinkedIn : https://www.linkedin.com/in/omar-aimer/).