2nd Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinic (DDI Workshop 2011)

Venue: Marbach Castle

Location: D-78337 Öhningen, Germany

Event Date/Time: May 01, 2011 End Date/Time: May 03, 2011
Early Registration Date: Jan 31, 2011
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In May/June 2010 the first International
Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions was held based on the
initiative of a group of international scientists and experts from academia and pharmaceutical industry.

The event was triggered by the notion that
the area of drug-drug interactions (DDIs) is
getting increasingly important and complex in view of continuously emerging new therapies, complex treatment algorithms for many widespread disease states and ageing populations in the industrialized countries. These factors converge into a frequently employed poly-pharmacotherapy with increasing risks for clinically significant DDIs. These developments represent substantial challenges for the pharmaceutical industry and regulatory bodies in the development and approval of new medicines, which need to be carefully and comprehensively considered by all stakeholders
and decision makers involved in the drug
development process.

Failures in the early recognition, mechanistic
elucidation (understanding) and proper management of DDIs, in turn, have resulted in significant health burden to patients, serious public safety concerns and drug withdrawals from the market in the past.

Today, however, the principle challenges in
the investigation and prediction of adverse
DDIs can be generally addressed in a more
targeted and evidence-based fashion, because
considerable progress has been made in the understanding of the underlying mechanisms of DDIs and the subsequent development of methodologies for the investigation of DDI susceptibility, and the extrapolation of outcomes of particular DDIs to other drug combinations.

In Europe, the scientific progress in the field over the last years is now reflected in the current draft version of the revised Note for Guidance Document on the Investigation of Drug Interactions (EMA / CHMP / EWP / 125211 / 2010) that was issued by the European Medicines Agency on April 22, 2010. Hence, a new regulatory framework is available to serve as a platform and regulatory benchmark for the discussion of essential requirements, methodologies and best practices in the field.

The 2010 Workshop combined a regulatory update on the investigation of DDIs from the European Rapporteur perspective(MPA, Sweden) along with a scientific update focusing on the investigation of metabolism- and transporter-based DDIs. Around 70 experts from pharmaceutical industry,contract research organisations and drug regulatory agencies from 10 European countries and the United States participated in the 1st International DDI Workshop at Marbach Castle. Based on the detailed feedback received from the expert audience on additional areas of interest requiring future consideration, the structure and content of the present Workshop was designed.

The topics of the 2nd Marbach Castle meeting
will be covered by international scientists
and experts from academia, pharmaceutical
companies, contract research organizations, consultancies and regulators. The program will provide a unique opportunity for scientific exchange and networking across company and organizational borders, and an opportunity to learn about the current state-of-the-art in the investigation of DDIs.

The organisers:
Hartmut Derendorf PhD, FCP
Robert Hermann MD, FCP
Amin Rostami-Hodjegan PharmD PhD, FCP
Oliver von Richter PhD,


+49 (0)7735 – 8130; info@schlossmarbach.de

Additional Information

Additional information: http://www.cr-appliance.com/img/ddi-workshop-2011.pdf?lang=eng