Michael Forstner | Integrated Safety risk manager
F.Hoffmann La Roche Ltd

Michael Forstner, Integrated Safety risk manager, F.Hoffmann La Roche Ltd

Dr. Michael Forstner is “Integrated Safety Risk Manager” at F. Hoffmann-La Roche in Basel. In this role his main duties are to develop and implement processes for the coherent and consistent global management of drug safety risks together with his colleagues at other Roche drug development sites. These processes include data driven, integrated safety management planning, the development of integrated solutions for signal detection, the implementation of meaningful benefit-risk assessment processes, and to develop methods for a systematic approach to identifying, assessing and improving drug safety risks. Michael is also the Leader of the Global Risk Management Planning Work Group, a cross- functional global committee within Roche to develop, implement and oversee efficient processes for the development, tracking and update of risk management plans, their global harmonization and coherence, and their comparability to US REMSs. Prior to joining Roche, Dr. Forstner worked in a variety of positions in pharmaceutical R&D at Pharmacia (Nerviano, Italy) and Novartis (Basel, Switzerland), 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 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. In his spare time, Michael loves to spend time outdoors with his children and to engage in various activities from skiing and hiking, to fishing, hunting and gardening. He is also an avid reader, and loves the opera and music in general.

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Appearances at this years' conference:

Day Two - Thursday 19th April 2012


@ 16.15
How personalised medicine and the co development of therapeutics and diagnostics is influencing benefit risk management in decision making

- The co-development of therapeutics and diagnostics based on a variety of biomarkers is currently re-shaping the pharmaceutical industry.
- Many diagnostics are based on safety relevant biomarkers, thus enabling early identification of patients at higher risk from a particular treatment. This has a direct but different effect on the benefit-risk balance of a drug for different patients.
- Patients and healthcare providers need to understand the impact of personalized medicine, other important stakeholders will need to adapt procedures to accommodate to the changing landscape.
- The industry, regulatory authorities, and medical societies will have to work together to provide patients and physicians with a toolbox to enable fact based decision making on a particular treatment.
 

  • › Michael Forstner, Integrated Safety risk manager, F.Hoffmann La Roche Ltd
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