Michael von Forstner | Head of Safety Science, Global Pharmacovigilance and Patient Safety
Sobi (Swedish Orphan Biovitrum)

Dr. Michael Forstner is Head of Safety Science, Global Patient Safety and Pharmacovigilance at Swedish Orphan Biovitrum AB (Sobi), focussing on sound scientific approaches to establishung and maintaining favourable benefit-risk profiles of Sobi's products in real-world use. Michael has over 20 years industry experience in various roles in R&D and drug safety in different pharmaceutical companies and as a consultant, and has contributed to several successful marketing authorizations of innovative medicines and biosimilars by developing workable, efficient risk management measures, mostly in the oncology and CNS therapeutic areas. His current key interests are applications of real-world evidence in benefit-risk decision making, the integration of digital aRMM approaches into the wider healthcare system, and the use of artificial intelligence in pharmacovigilance and patient safety. As a past chair of the PV Working Group of Medicines for Europe, he has represented the organization at EMA working group and stakeholder meetings, driving an industry position that shows the industry as pro-active partners of regulators, HCPs and patients in ensuring the safety and effectiveness of medicines.  Michael also represented the International Generics and Biosimilars Association at an ICH Working Group on Real-World Evidence. In addition, he acts as instructor for DIA courses on benefit-risk and signal management, as well as at the European Centre for Pharmaceutical Medicine, and he is a frequent speaker at international scientific and industry conferences. In his spare time Michael likes to be outdoors with his family and his dogs, to go hiking, skiing, fishing, hunting or horse-back riding. He is also an avid reader and loves to go to the opera.