Conducting Clinical Trials Under the EU Clinical Trials Directive

Venue: The Rittenhouse Hotel

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Feb 26, 2004 End Date/Time: Feb 27, 2004
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Description

The implementation deadline for the EU Clinical Trials Directive is almost here. Any company conducting a clinical trial in Europe must adhere to the new regulation as interpreted by the different EU Member States from May 2004.

A clear understanding of the true practicalities of implementation is now needed, along with practical compliance solutions for drug companies.

Furthermore, drug companies need to fully realize the challenges and opportunities presented by the Directive to ensure that their compliance strategies maximize the Directive's advantages whilst prepare for the stumbling blocks it presents.

To meet this need, the Institute for International Research is proud to bring you Conducting Clinical Trials Under the EU Clinical Trials Directive, February 26-27, 2004, Philadelphia.

The mission of this seminar is to examine key aspects of the Directive's implementation and the impact on drug companies.
In particular, we focus on the:

varying interpretations and implementation of the Directive among EU Member States/EU Accession Countries
stumbling blocks inherent in the Directive and likely paths for resolution
practical compliance strategies
We begin Day One with an interactive half-day workshop led by Andrew G. Clair, Director Regulatory Operations, Worldwide Safety and Risk Management, PFIZER on Preparing for GCP Inspections and Audits Under the EU Clinical Trials Directive.


This workshop provides attendees with practical insights into efficient and economical approaches for preparing for GCP inspections and audits after May 2004. Following in the afternoon the seminar begins with a focus on EU Member State/EU Accession Countries interpretation and implementation of the Directive. We also examine how the Directive interfaces with ICH GCP and FDA regulations, and we look at the some of the challenges and opportunities the Directive presents with a view to overcoming such stumbling blocks and maximizing the opportunities.

On Day Two, we take a closer look at some of the specific aspects of the Directive along with practical compliance strategies for: multi site/multi country trials; Phase I trials; compliance with GMP for Investigation Medicinal Products; meeting application procedures for regulatory authorities. We also examine the role, functionality and practicalities of the EUDRACT and SUSAR databases and the implications for drug companies.

The format of the seminar has been designed to maximize interaction between participants. Discussion and the sharing of ideas and experiences is encouraged throughout the two days.

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