Agenda

Day 1 Dec 03, 2019

1:00 PM — 5:30 PM

The Evolving Disclosure/Transparency Landscape (Workshop)

Day 2 Dec 04, 2019

8:00 AM — 8:30 AM

Registration and Welcome Coffee

8:45 AM — 10:15 AM

Session 1: Latest Updates on Clinical Trial Portal and Its Functionalities

10:15 AM — 10:30 AM

Vendor Presentation

10:30 AM — 11:00 AM

Coffee Break

11:00 AM — 12:30 PM

Session 2: Global Harmonization for Clinical Trial Transparency and Disclosure

12:30 PM — 2:00 PM

Lunch

2:00 PM — 3:30 PM

Session 3: Health Canada and EMA Publication Policies

3:30 PM — 3:45 PM

Vendor Presentation

3:45 PM — 4:15 PM

Coffee Break

4:15 PM — 5:35 PM

Session 4: Brexit - the Use of MHRA System and Requirements

Day 3 Dec 05, 2019

8:00 AM — 8:15 AM

Recap

8:15 AM — 9:45 AM

Session 5: Transparency Implications of the EU Medical Device Regulations (MDR)

9:45 AM — 10:00 AM

Vendor Presentation

10:00 AM — 10:30 AM

Coffee Break

10:30 AM — 11:15 AM

Session 6: Sharing of Individual Patient Data From Clinical Trials ICMJE Data Sharing Requirements: Implications For Clinical Trial Sponsors

11:45 AM — 12:00 PM

Vendor Presentation

12:00 PM — 1:00 PM

Lunch

1:00 PM — 2:30 PM

Session 7: Lay Summaries and Regulatory

2:30 PM — 3:00 PM

Coffee Break

3:00 PM — 4:15 PM

Session 8: GDPR

4:15 PM — 4:30 PM

Wrap-up and Closing Remarks

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Clinical Trial Disclosure & Data Transparency Conference

Agenda

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