13 Okt 2014 - 17 Okt 2014

Clinical safety: Post-Approval (course 5.2), Paris (F)

This course will provide participants with an overview of the current knowledge on the clinical assessment and follow-up of drug safety post-approval and human safety. Drug safety in human patients is the ultimate goal of drug safety scientists. Because limitations of patient populations studied during drug development and uncertainties related to potential drug-drug interactions or rare or idiosyncratic adverse reactions, it is important to pay careful attention to human safety to achieve a better understanding of the safety of drugs on the market used in a wider patient population, for long treatment duration and on various co-medication compared to the population included in the approval package. Human safety plays an important role for assessing drug safety profile in daily conditions of use, which includes adherence to recommended modalities of therapeutic use (pharmacovigilance) as well as exposures deriving from accidental or intentional acute poisonings (clinical toxicology and toxicovigilance), misuse or abuse of therapeutic agents (pharmacodependence) or unintended indications. 

Organizer

SafeSciMET

Location

Université Paris-Sud Faculté de Pharmacie 5 rue Jean-Baptiste Clément 92290 Châtenay-Malabry (F)

Link to Event

http://www.safescimet.eu/registration/docs/brochure/course_brochure_111.pdf