Sheraton National Hotel Arlington , Arlington, VA, USA
The Evolving Clinical Trial Disclosure Landscape
Stay Informed of the Latest Requirements and Developments in the Global Clinical Trial Disclosure Environment. 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. FEATURED TOPICS
• 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
– ClinicalTrials.gov Quality Review
– Challenges Unique to Small Companies and Academic Researchers Attendees may visit the tabletop exhibits during the event and receptions. Event Code:
11031
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