The Evolving Clinical Trial Disclosure Landscape

Venue: Sheraton National Hotel Arlington

Location: Arlington, Virginia, United States

Event Date/Time: Sep 13, 2011 End Date/Time: Sep 14, 2011
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Engage in interactive discussions with biopharmaceutical and medical device experts as well key agency personnel from NLM, FDA and EMA on how to ensure compliance, efficiency, and consistency in clinical trial disclosure. This year’s conference will offer collaborative breakout sessions that will give you the opportunity to interact with and gain practical advice from colleagues, peers, and other stakeholders.

• US, Regional, and International Clinical Trial Registries
• Leveraging Information Technology to Upload to Registries and Results Databases
• Registries, Results Databases, and the Interrelationships with Publications
• Devices and Disclosure
• Impact of Disclosure on NIH Research/Academia
• FDA Plans for Auditing Procedures
• Collaborative Breakout Session Topics:
– Preparing Your Protocol and CSR for Future Disclosure
– Post-market and Observational Studies
– Quality Review
– Challenges Unique to Small Companies and Academic Researchers

Attendees may visit the tabletop exhibits during the event and receptions.

Target Audience:
Professionals involved in:
• Clinical trial disclosure
• Clinical trials
• Medical communications/writing
• Clinical investigation
• Statistics
• Regulatory affairs
• Quality assurance
• Health policy
• Medical /Scientific affairs
• Health economics and outcomes research