Clinical Trial Disclosure: Towards a More Transparent World

Agenda

Day 1 Sep 30, 2013

9:00 AM — 5:00 PM

Clinical Trial Disclosure Tutorial 1: A Sane Approach to Entering Results in ClinicalTrials.gov

1:00 PM — 5:00 PM

Tutorial 2: Is Your Protocol Ready to Be Published

Day 2 Oct 01, 2013

8:45 AM — 9:00 AM

Welcome and Opening Remarks

9:00 AM — 10:30 AM

Session 1: Clinical Trial Registries and Results Disclosure in the EU and US – An Update

11:00 AM — 12:30 PM

1:30 PM — 2:45 PM

Session 3: Panel Discussion - Meeting Regional Disclosure Requirements while Aiming for a Global Standard

3:00 PM — 4:15 PM

Session 4: Panel Discussion - Impact of Increasing Regulatory Transparency on Publications

4:30 PM — 6:00 PM

Session 5: Disclosing Participant-level Data: Goals and Challenges

Day 3 Oct 02, 2013

8:45 AM — 9:00 AM

Overview of Day 1

9:00 AM — 10:30 AM

Session 6: The Right to Know: Patients and Clincal Trial Results

11:00 AM — 12:30 PM

Session 7: Non-interventional Studies: The Next Wave of Disclosure Requirements

1:30 PM — 3:00 PM

Session 8: Clinical Trial Disclosure - FDA Enforcement Activities

3:00 PM — 3:15 PM

Summary and Closing Remarks

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