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/).

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.

Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit-risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.

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.