New Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investiga (DDI-Workshop)
Venue: Marbach Castle
|Event Date/Time: May 30, 2010||End Date/Time: Jun 01, 2010|
New Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions
Marbach Castle, Lake Constance, Germany
May 30th - June 1st 2010
The present Note for Guidance for the Investigation of Drug Interactions by the European Agency for the Evaluation of Medicinal Products (EMEA) was issued in the nineties. Over the last decade, however, considerable knowledge has been gained about underlying mechanisms of drug-drug interactions (DDIs) and the applied methodologies for the investigation of DDI potential and extrapolation of outcomes to other drug combinations knowing that investigating all permutation of various drug combinations is unrealistic. To integrate current knowledge, the EMEA is currently revising its DDI Note for Guidance document to update several areas, and the revised draft Guideline will be published for public consultation in 2010.
The meeting "New Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions" will combine a regulatory update on the investigation of DDIs from the European perspective with a scientific update on the investigation of DDIs. Four sessions comprising a â€˜regulatory updateâ€™, â€˜metabolic drug-drug interactions (mDDI)â€™, â€˜non-metabolic DDIs & PGx of DDIsâ€™, and â€˜tools in design & evaluation of DDI-trials for better timing of DDI-trials in course of clinical developmentâ€™ will address the latest knowledge and strategies in this key area of drug development. Commonalities and differences between US and EU regulatory requirements in conducting DDI studies will also be addressed.
The topics will be covered by international experts from European regulatory authorities, pharmaceutical companies/consultancies and academia. The program will provide a unique opportunity to learn about the European perspective on the investigation of drug interaction and to gain a better understanding on â€˜which studies are needed when?â€™, and â€˜how these should be performed / interpreted?â€™.
The meeting will be held in Marbach Castle, located on the beautiful surrounding of the Western shore of Lake Constance within a 45 min distance to Zurich International Airport (see the following web site: www.schlossmarbach.de ).
â€¢ Hartmut Derendorf, PhD FCP; College of Pharmacy, University of Florida, USA
â€¢ Robert Hermann, MD FCP; cr.appliance, Germany
â€¢ Amin Rostami-Hodjegan, PhD FCP; Faculty of Medical and Human Sciences,
University of Manchester, UK
â€¢ Oliver von Richter, PhD FCP; Dept. Exploratory Medicine, Merck Serono Germany;
Uwe Fuhr, MD; Clinical Pharmacology, University of Cologne, Germany
Isabelle Ragueneau-Majlessi; Clinical Pharmacology, University of Washington, USA
Supporting Professional Organisations:
The meeting is supported by the following professional organisations :
â€¢ Association for Applied Human Pharmacology (AGAH)
â€¢ American College of Clinical Pharmacology (ACCP)
â€¢ BioLAGO â€“ The international Life Science Network in the Lake Constance Region
Contact & Informations:
Phone: +49 (0)7732 820 951
Fax: +49 (0)7732 820 953