It is essential that the risk from Phase I studies is minimized and that any unanticipated harm be rapidly detected and contained.
Toronto, Canada (PRWEB) April 04, 2013
Phase 1 studies are typically aimed at optimizing dosage and furthering pharmacokinetic studies — in these cases, the risk is not balanced by a potential benefit for the participating healthy volunteers or patients. For this reason, it is essential that the risk is minimized and that any unanticipated harm be rapidly detected and contained.
Valuable directions to ensure subject safety are given by, for instance, the 2007 EMEA guideline on identification and mitigation of Risks in First-In-Human Trials and the MHRA Phase 1 Accreditation Scheme.
The challenge remains in translating the guidelines into daily practice in a Phase I setting. New compound classes and design elements pose unique challenges to the risk mitigation process. Therefore the risk mitigation process is not only evolving within a single study but has to continue evolving as a whole.
Join our speaker, Dr. Thijs van Iersel, Senior Director of Scientific Affairs at PRA for an in-depth look at strategies to implement risk minimization procedures in Clinical Pharmacology Units at PRA.
A Q&A with the audience will follow the main presentation.
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