Head of Safety Science

Sobi

Biography

Dr. Michael Forstner was the Head of Clinical Safety and Pharmacovigilance, Biosimilars at Biogen International, focusing on ensuring compliant and efficient pharmacovigilance processes to ensure the maintenance of favourable benefit-risk profiles of Biogen’s biosimilar 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 by developing workable, efficient risk management measures, mostly in the oncology and CNS therapeutic areas.

As a past chair of the PV Working Group of Medicines for Europe, he has been representing 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 represents the International Generics and Biosimilars Association at the ICH. 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 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.