Upcoming Event: US FDA Regulatory Compliance Workshop
9/16/2008
Event: US FDA Regulatory Compliance Workshop
Dates: October 20, 2008 (Shanghai) and October 21, 2008 (Beijing)
Contact: David Xue, PharmaGuys
Email:
dxue@pharmaguys.comFax: +86 10 85300938
Learn how to demystify the US FDA and turn them into your partner and not your adversary
Presented by: Dr. Joshua Sharlin:
- Former US FDA Drug Reviewer, Washington, DC
- World class trainer to over 35,000 attendees during the last 10 years on mission critical topics to deliver US FDA regulatory compliance
- Master consultant to global pharmaceutical , biotech, biologics and medical devices companies
Session 1: Understanding how US FDA Reviewers Think and Work
Session 2: US-FDA Requirements For Entering Clinical Trial Information into ClinicalTrials.gov
Session 3: Latest US-FDA Regulatory Actions Affecting the Generic Drug Industry
Session 4: Clinical Trials Conducted Outside the United States: New US-FDA Regulations