Safety and Risk Management in Translational Medicine

Posted:
3
March 2007

Safety and Risk Management in Translational Medicine

"Safety and Risk Management in Translational Medicine"We will be attending and exhibiting at the AGAH – Annual Meeting 2008 in Weimar (Germany) on 18-19 April.This conference focuses on finding appropriate techniques and strategic approaches to improve the safety of study participants, to minimize risk, and to improve the predictive value of the safety profile for a new compound. Concepts and guidelines for the new regulatory environment for Phase 1 studies in the EU will be presented. Experts from all research areas involved will share their experience, discuss the limitations of interpreting the clinical relevance of their studies' results and present concepts for improving the drug development process.Drug development must find a balance between the excitement of discovering new treatment options and the protection of subjects participating in clinical trials. Healthy volunteers and staff responsible for their well being are relying on the adequacy of the procedures applied to minimize risk during the exploratory phases. Hence, the results of pre-clinical pharmacological models, toxicological studies and foregoing clinical trials in healthy volunteers and patients are expected to be a predictive value for the next step. With the increasing number of biologicals and compounds with completely new mechanisms of action this concept may no longer be satisfactory as has been painfully experienced with the first administration of TGN1412 to healthy volunteers.Today's drug development is subjected to a highly regulated and segmented setting. A closer cooperation between pre-clinical and clinical experts is essential to identify and select the appropriate investigational tools, to early identify potential safety issues, and to translate the findings of exploratory trials into efficacious and safe new drugs.We look forward to meeting you at the exhibition. Please visit the Richmond Pharmacology team at our stand to discuss your Early Phase outsourcing requirements.Hotel Registration Form

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