Pharmacovigilance & Clinical Trials

Biography

Dr. Michael Forstner is Managing Partner and Head of Risk Management and Business Process Management Practice at Mesama Consulting International, where his 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 methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development and implementation of additional risk minimization and PV measures in the context of RMPs. Before entering into his current role, Dr. Forstner was Head of Regional Pharmacovigilance Europe at Boehringer-Ingelheim. His main focus at BI had been to establish a proactive and highly integrated benefit-risk management organization with strong links to other functions, while maintaining compliance with all local regulations in the 35 countries of his region. From 2009 to 2013, he was Process Development Leader in Drug Safety and Chair of the global Risk Management Working Group at Roche, Basel, where he was – amongst other duties – responsible for all aspects of global benefit-risk management planning and implementation of RMPs. Prior to this he worked in a variety of positions in pharmaceutical R&D at Pharmacia (Nerviano, Italy) and Novartis (Basel, Switzerland), focusing mostly on signal transduction pathways in oncology and CNS disorders, and in drug liability risk management at Zurich Financial Services. He studied biochemistry and medicine in Graz, Austria, holds a PhD in biochemistry from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland, did postdoctoral work at UC Berkeley/Lawrence Livermore National Laboratory, California in the area of structural enzymology and biophysics, and was Assistant Professor of Molecular Structural Biology at Sveriges Lantbruksuniversitetet in Uppsala, Sweden. Recently he also obtained a postgraduate certificate in Pharmacovigilance and Pharmacoepidemiology from the London School of Hygiene and Tropical Medicine. In his spare time, Michael loves to spend time outdoors with his children and dogs and to engage in various activities from skiing and hiking, to fishing, hunting, horseback riding and gardening. He is also an avid reader, and loves the opera and music in general.

Research Interest

planning, development, implementation and evaluation of (benefit-)risk management solutions