BENEFIT/RISK ASSESSMENT OF MEDICINES TO ACHIEVE SHARED OBJECTIVES: FROM RESEARCH TO REALITY
1-3 September, 2010
Krakow (Poland)
Relevant European experts from the European Medicines Agency (EMA), National Agencies, pharmaceutical companies, and patient associations gathered in Krakow (Poland) for the III Foresight Training Course.
Health authorities were responsible for ensuring patient safety while directing efforts toward addressing critical therapeutic needs. At the same time, they aimed to balance the interests of both the industry and patients.
The course was held outside Italy, with Krakow chosen for its historical significance and its role in the integration of Eastern European countries into Europe.
The III FTC was organized by Fondazione Gianni Benzi, in collaboration with the National Medicines Institute, the Children’s Memorial Health Institute in Warsaw, SIAR (Italian Society of Regulatory Affairs), MEGRA (Middle European Society of Regulatory Affairs), TEDDY (Task-force in Europe for Drug Development for the Young), the Master in Regulatory Sciences “Gianni Benzi” (University of Pavia), and the CVBF (Consortium for Biological and Pharmacological Evaluations).
The Foresight Training Courses focused on key topics in the pharmaceutical world, research, and regulatory affairs, addressing the increasing complexity of regulatory procedures for Marketing Authorization applications. These courses served as educational tools for reviewing the processes involved in drug study, approval, and use.