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RS/APQ Open Forum
Clinical Trial Materials – Clinical and CMC Challenges for Successful Conduct of Multi-Regional Clinical Trials
Thursday, November 15
1:30 pm – 5:00 pm
Funded by Grants from
As pharmaceutical and clinical development has become more global, a number of pharmaceutical companies are choosing to perform clinical trials in several regions, in particular South East Asia (India and China), Eastern Europe and Latin America. This presents some unique challenges in terms of filing clinical trial applications in those regions, getting the clinical trial materials to those regions and ensuring that their quality and integrity are not compromised. Good coordination and planning is necessary to provide the necessary materials for the clinical trials and to coordinate the clinical site activities. This open forum will provide some insights into the unique clinical and CMC challenges in conducting multi-regional clinical trials and will provide an excellent learning opportunity for pharmaceutical scientists, clinical coordinators and regulatory personnel. The session will include speakers from a regulatory agency and the pharmaceutical industry in the areas of clinical coordination, clinical manufacturing and packaging and testing, and clinical pharmacology/toxicology.
An additional fee is required to attend the RS/APQ Open Forum. To register, select the appropriate registration fee under the Special Events section of the registration form.
Moderators
Gopi Vudathala, Ph.D.
Sanofi-Aventis U.S., Inc.
Saji Thomas, Ph.D.
Par Pharmaceuticals
SPEAKERS
How are Clinical Trials in Other Regions Perceived in US Drug Applications
Ni Khin, M.D.
U.S. Food and Drug Administration
Clinical Pharmacology/Toxicology in Regional/Ethnic Patient Populations and Impact on Global Submissions
Jurij Petrin, M.D.
Pharmaceutical Regulatory Services, Inc.
Key Regulatory Challenges
Richard Lowenthal, M.S.
Pacific Link Consulting
Chemistry, Manufacturing and Control Issues with Clinical Trial Materials for New Clinical Sites/Regions
David Bernstein, Ph.D.
Bernstein Consulting
Analytical and Stability Implications for Clinical Trial Materials
Ganapathy Mohan, Ph.D.
Sanofi-Aventis
Panel and Open Discussion
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