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Holiday Inn London Kensington Forum

Feb 21, 2017 8:00 AM - Feb 22, 2017 12:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Post-Authorisation Studies

This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed.

Faculty

Michael  Busch-Sørensen

Michael Busch-Sørensen

Board Member, Danish Society for Pharmacoepidemiology, Denmark

Dr. Busch-Sørensen is a physician with 7 years of clinical practice mainly in internal medicine. Has passed the special module of Biostatistics & Epidemiology (part of Master of Public Health) as well as being bachelor of commerce in Marketing all at Copenhagen University. Dr. Busch-Sørensen has published multiple peer-reviewed manuscripts. Dr. Busch-Sørensen is serving as member of the board of the Danish Pharmacoepidemiology Society. He has been invited to speak on GVP, GPP, and Data Privacy as he has arranged and hosted multiple molecular profiling meetings between industry and academia. The IT angle in data privacy has been addressed extensively too, including validation of systems, ICH E15 implementation and training.

Michael  Forstner, PhD, MPH, MSc

Michael Forstner, PhD, MPH, MSc

Head of Global Safety Science, SOBI, Switzerland

Michael's 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 and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

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