Agenda

Día 1 18 sep 2019

7:30 AM — 4:30 PM

Short Course Registration

8:30 AM — 12:00 PM

Short Course 1: Clinical Trial Disclosure 101

1:00 PM — 4:30 PM

Short Course 2: Practical Approaches to Using the ClinicalTrials.gov PRS

Día 2 19 sep 2019

7:00 AM — 8:15 AM

Continental Breakfast, Exhibits, and Networking

7:00 AM — 4:30 PM

Registration

8:00 AM — 8:15 AM

Welcome and Opening Remarks

8:15 AM — 8:45 AM

Keynote Address: Data of, by, and for the People: How Sharing Data with Participants will Save Clinical Research

8:45 AM — 9:30 AM

Session 1: Implementation of the Health Canada Requirements of Public Release of Clinical Information

9:30 AM — 9:45 AM

Refreshment, Exhibits, and Networking Break

9:45 AM — 11:00 AM

Session 2: Global Approaches of Data Sharing and ICMJE Data Sharing Requirements

11:00 AM — 11:15 AM

Refreshment, Exhibits, and Networking Break

11:15 AM — 12:30 PM

Session 3: Good Compliance is Good Business

12:30 PM — 1:30 PM

Luncheon, Exhibits, and Networking Break

1:30 PM — 2:30 PM

Session 4: Disclosure of Innovative Trial Designs: Adaptive Designs and Master Protocol

2:30 PM — 3:00 PM

Refreshments, Exhibits, and Networking Break

3:00 PM — 3:30 PM

Session 5: Featured Oral Abstract

3:30 PM — 4:30 PM

Session 6: Overview of Disclosure Requirements for Federally Funded Trials

4:30 PM — 5:30 PM

Poster Presentations and Networking Reception

Día 3 20 sep 2019

7:00 AM — 8:00 AM

Continental Breakfast, Exhibit, and Networking

7:00 AM — 3:00 PM

Registration

7:30 AM — 7:55 AM

DIA Clinical Trials Disclosure Community Open Meeting

7:55 AM — 8:00 AM

Welcome to Day Two

8:00 AM — 9:15 AM

Session 7: Status and Latest News on the EU Regulatory Requirements Related to Disclosure of Clinical Data

9:15 AM — 10:15 AM

Session 8: Oral Abstract Presentations

10:15 AM — 10:30 AM

Refreshments, Exhibits, and Networking Break

10:30 AM — 11:30 AM

Session 9: Protecting Confidential Information in Summaries of Trial Results

11:30 AM — 11:45 AM

Refreshments, Exhibits, and Networking Break

11:45 AM — 1:00 PM

Session 10: US Regulatory and Policy Updates: FDA and ClinicalTrials.gov Developments

1:00 PM — 2:00 PM

Luncheon, Exhibits, and Networking

2:00 PM — 3:00 PM

Session 11: Valuing Patient Input into Clinical Trials

3:00 PM — 3:15 PM

Closing Remarks

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Global Clinical Trial Disclosure and Data Transparency Conference

Agenda

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