9th Annual Biomarkers Congress
Clinical Trials Asia
The Moscone North Convention Center
747 Howard Street
San Francisco-94103, CA
www.PEGSummit.com
Molecular diagnostics

LAUNCHING SUCCESSFUL PRODUCTS IN THE
DEVELOPING WORLD

Molecular Diagnostics
Mastering Medicinal Chemistry
Pathway Analysis
Stem Cells Congress
R&D Risk Mitigation
Clinical Trials Asia
Preclinical Development
Translational Medicine
Cytokine-Based Therapeutics
Cancer Molecular Markers
Trends in Drug Safety
THE PREDOMINANT DISCOVERY, DIAGNOSTIC, AND DEVELOPMENT EVENT

Schedule of Presentations:

Tuesday, March 25, 2008
07:00:00 Registration Open
08:00:00 PLENARY KEYNOTE SESSION
Wednesday, March 26, 2008
07:00:00 Registration Open
08:00:00 PLENARY KEYNOTE SESSION
09:40:00 Grand Opening Refreshment Break in the Exhibit Hall DESIGNING AND PLANNING TRIALS IN INDIA,CHINA AND SOUTHEAST ASIA
11:00:00 Organizer’s Welcome and Chairperson’s Remarks Micah Lieberman
11:10:00 Utilizing and Integrating Global Clinical Study Local Data from China to Mutually Support Global and Local Applications in Order to Benefi t Unmet Medical Needs James Cai
11:40:00 Clinical Research Landscape in India Chandrashekhar Potkar
12:10:00 Optimizing Return on Investment (ROI) of Multinational and Min Irwin
12:40:00 Technology Spotlight Sponsored by Lowering Geographic Barriers in Global Clinical Trials with Digital Pathology Steven J Potts
13:10:00 Walk & Talk Luncheon in the Exhibit Hall
14:15:00 Chairperson’s Remarks
14:20:00 Emerging Hub for Global Clinical Trials “India: The Ideal Choice” Kamala Rai
14:50:00 Accelerate Oncology Clinical Development in Asia Michael Shi
15:20:00 Roles and Functioning of Institutional and Independent Ethics Committees in India Y K Gupta
15:50:00 Utilizing and Integrating Local Clinical Data from Asia to Mutually Support Global and Regional Applications
16:20:00 Reception in the Exhibit Hall (Sponsorship Available)
17:00:00 Break-out Discussions in the Exhibit Hall
18:00:00 End of day
Thursday, March 27, 2008
08:25:00 Chairperson’s Remarks
08:30:00 SWOT Analysis of Pharmacovigilance, PMS and PSUR in India Y K Gupta
09:00:00 Safety Reporting in India Clinical Research Environment Kamala Rai
09:30:00 The Strategic Planning Behind the Clinical Site Allocation in Emerging Economies: An Industry-Wide View Fabio Thiers
10:00:00 Technology Spotlight Challenges and Experiences in Conducting Clinical Trials in India Dilip R Limaye
10:15:00 Technology Spotlight (Sponsorship Available)
11:30:00 Country and Site Selection for Global Clinical Trials Fidela Li Moreno
11:30:00 Poster Competition & Refreshment Break in the Exhibit Hall
12:00:00 Effectively Identifying, Selecting and Engaging Clinical Sites
12:30:00 Luncheon Workshop (Sponsorship Available) or Lunch on Your Own
13:30:00 Break
13:45:00 Chairperson’s Remarks NAVIGATING THE REGULATORY LANDSCAPE THROUGHOUT ASIA
13:50:00 Best Practices for Engaging Regulatory Authorities in Asia Sudhir Srivastava
14:20:00 Recent Regulatory Changes in India Chandrashekhar Potkar
14:50:00 Strategic and Regulatory Considerations before Conducting Clinical Trials in China Yiyou Chen
15:20:00 Plenary Keynote Speaker Ice Bound - A Doctor’s Incredible Battle for Survival at the South Pole Jerri Nielsen
16:00:00 Ice Cream Refreshment Break in the Exhibit Hall with BEST OF SHOW AWARDS
16:45:00 Navigating the Regulatory Landscape throughout Asia
17:45:00 End of Session
Friday, March 28, 2008
08:30:00 Chairperson’s Remarks
08:35:00 Designing and Planning Trials in India, China and Southeast Asia: A Western-Asian Business Model Ulrich Elben
09:05:00 Effective Strategic & Tactical Integration of Asia in Your Molecule’s Clinical Development Plan Chet Elias
09:35:00 Clinical Trials in India - Phase I Brijesh Regal
10:05:00 Technology Spotlight (Sponsorship Available)
10:20:00 Coffee Break in the Foyer
11:00:00 Conducting Phase III and IV Trials in China: Practical Considerations Mark Engel
11:30:00 Initiating HIV Clincal Trials in India Ronald Gugliotti
12:00:00 Luncheon Workshop (Sponsorship Available) or Lunch on Your Own
13:00:00 Chairperson’s Remarks
13:05:00 Are You Ready for an FDA Inspection? Cherif Benattia
13:35:00 Trials and Tribulations of Conducting Clinical Studies in India: Lessons Learned Vasantha P Rao
14:05:00 Best Practices for Managing a Global Clinical Supply Chain Speaker to Be Determined
14:35:00 Closing Summary and Conclusions: Realistic Opportunities and Main Challenges to Conducting Trials in India, China and Southeast Asia
15:05:00 Close of Conference
4th Annual Pharma R&D Asia Congress
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