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Event Details
Day 1
8:00 - 9:00
Continental Breakfast
9:00 - 9:30
Opening Remarks/Introductions
9:30 - 10:30
Emerging Markets: Opportunities and Challenges
10:30-10:45
Break
10:45-11:45
Orphan Drug Development in Emerging Markets
11:45-12:45
Study Design Challenges and Solutions
12:45-1:45
Lunch
1:45-2:30
How to Get Clinical Trial Approval in India
2:30-3:15
Recent Changes in the Indian Regulatory Processes
3:15-3:30
Break
3:30-4:00
Ethical standards for global clinical trials – An IRB’s perspective
4:00-5:00
Roundtable Discussion – Quality Issues Impacting FDA Submissions
5:00-5:30
Wrap-Up
5:30-7:30
Reception
Day 2
8:00-9:00
Continental Breakfast
9:00-9:45
Preparing for an FDA GCP Audit
9:45-10:30
Regulatory Trends in Global Trials: Major Issues with Non-US Clinical Data
10:30-10:45
Break
10:45-11:30
Roundtable Discussion – Regulatory Standards for Quality Clinical Trials
11:30-12:00
Wrap-Up: Checklist for Planning, Executing and Managing Clinical Trials in India
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When & Where
Sheraton Hotel
920 King Farm Blvd
Rockville,
MD 20850
Thursday, April 29, 2010 at 8:00 AM - Friday, April 30, 2010 at 12:00 PM (ET)
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