ENSURING QUALITY AND BALANCING RISKS FOR MULTIREGIONAL CLINICAL TRIALS: STATISTICAL, CLINICAL, REGUL

Venue: Double Tree Hotel and Executive Meeting Center

Location: Bethesda, Maryland, United States

Event Date/Time: Oct 26, 2010 End Date/Time: Oct 27, 2009
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Description

With a multitude of cultural diff erences, diverse regulatory guidances and processes, and a variety of local medical practices, there is a clear need to develop a road map in order to reach successful completion of a quality clinical trial. This workshop will engage regulators and industry to examine the issues that need to be considered to conduct a successful MRCT that generates data acceptable for regulatory decison making. This is a multidisciplinary conference, as the many considerations and opportunities off ered by MRCTs are of a broad scope and not particular to any single expertise. The conference will provide discussions, experts and case studies addressing ethical, regulatory, operational, statistical, and clinical considerations of MRCTs, including:
• Access to medicines and post-trial care
• Ethical considerations
• Intellectual property protection
• Understanding the role of human factors, risk taking, and cultural differences in successful MRCTs
• Statistical methods to determine the consistency of results across different regions
• Regulatory issues across multiple countries when planning a placebo-controlled trial

Industry MRCT Working Group-Key Issues Team will contribute the following topics to the conference:
1. Identifying regional similarities and diff erences with respect to MRCTs
2. Designing and conducting quality MRCTS
3. Assessing consistency of results across regions
4. Exploring international regulatory obstacles to planning unifi ed MRCTs
5. Addressing international regulatory diff erences when planning unified MRCTs



Event Code:
10034

Venue

8120 Wiesconsin Avenue
Bethesda
Maryland
United States
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