Dr. Michael Forstner is Senior Director Patient Safety at PRA Health Sciences, focussing on developing and delivering efficient methods for benefit-risk management of drugs and on the study of medicinal product safety 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.
Amongst other tasks, his current focus is on developing benefit-risk and signal management strategies, optimizing the use of real-world data in pharmacovigilance with an emphasis on oncology – in particular immune-oncology and advanced therapies, and finding new, effective approaches for the analysis and management of medicinal products’ benefit-risk profiles.
Michael is also co-chair of the PV working group of Medicines for Europe, the industry association representing the generics and biosimilars industries in the EU and has been representing the organization at EMA working group and stakeholder meetings. In this capacity he 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 a lecturer at the Basel university’s European Centre for Pharmaceutical Medicine and is a frequent speaker at international scientific and industry conferences.
In his spare time, Michael loves to be outside with his children, dogs and horses, to go to the opera, and to cook.