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Holiday Inn London Kensington Forum

Jun 13, 2016 8:00 AM - Jun 14, 2016 12:00 PM

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

Post-Authorisation Studies (PAS)

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  Forstner, PhD, MPH, MSc

Michael Forstner, PhD, MPH, MSc

Managing Director, Head of Pharmacoepidemiology Practice, Mesa Laubela-Consulting, 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 signal and 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.

Gro  Laier, MD

Gro Laier, MD

PV Expert, Denmark

Gro Laier has been working within Pharmacovigilance for more than 25 years of these 1 year at Base Life Science, 4 years at Leo Pharma, 16 at Novo Nordisk, two at The Danish Medicines Agency and two at H Lundbeck. She graduated as a physician from University of Copenhagen in 1987. After a few months employment as a Register at a hospital in Copenhagen, she worked for 7 years within toxicology, before she took a position at the Danish Medicines Agency and started a long career within Pharmacovigilance.

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