ENSURING QUALITY AND BALANCING RISKS FOR MULTIREGIONAL CLINICAL TRIALS: STATISTICAL, CLINICAL, REGULATORY, AND ETHICAL FACTORS

Date(s) And Time(s):
Oct 26 2010 8:00AM - Oct 27 2010 5:00PM

Location:
Double Tree Hotel and Executive Meeting Center
8120 Wiesconsin Avenue
Bethesda, MD 20814

Interest Area(s):
Clinical Research, Outsourcing, Project Management, Public Policy/Law/Corp. Compliance, Regulatory Affairs, Research & Development

Overview:

Join Industry and Regulatory Leaders to Address Multi regional Clinical Trial Opportunities and Risks from a Global Perspective

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

Target Audience:
Experienced industry clinical research professionals with drug development experience seeking current knowledge of more advanced topics involving issues with the design,
implementation, maintenance, analysis, and registration of multiregional clinical trials. This includes:
• Statisticians
• Mid- senior-level project managers/decision makers
• Regulatory aff airs professionals
• Medical aff airs professionals
• Site directors
• Investigator site managers
• Research and strategic development professionals
• Contract research organizations
• Public policy and law (including intellectual property) professionals

Event Code:
10034

Contact Information:
Contact Constance Burnett. Program Developer, Phone +1.215.293.5800
Fax +1.215.442.6199, email Constance.Burnett@diahome.org

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