2nd annual Clinical Data Disclosure and Transparency Summit: Full Schedule

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11:00am PDT

OPENING REMARKS

Tuesday October 15, 2024 11:00am - 11:10am PDT

Speakers

Emma Kindsvatter

Director of Content and Experience, MOMENTUM EVENTS

Tuesday October 15, 2024 11:00am - 11:10am PDT

OPENING/CLOSING REMARKS

11:10am PDT

FDA UPDATE: OVERSIGHT OF CLINICAL TRIAL TRANSPARENCY

Tuesday October 15, 2024 11:10am - 12:10pm PDT

Understand the Legal Transparency Expectations and Obligations, the FDA’s Risk-Based Approach to Oversight, and the Process for Noncompliance

Discuss the drive behind FDA’s commitment to ensure a complete record of interventional clinical trials is available
Detail clinical data disclosure requirements and expectations
Breakdown the FDA’s risk-based approach to prioritize compliance and enforcement actions for violations
Walk through the pre-notification process, timeline for action and potential consequences if none occurs

Tuesday October 15, 2024 11:10am - 12:10pm PDT

PLENARY SESSION

12:10pm PDT

GLOBAL REGULATIONS

Tuesday October 15, 2024 12:10pm - 12:40pm PDT

Understand Global Regulatory Differences To Ensure Your Company and Data Disclosure Practices Are Prepared For Global Sharing and Safety

Analyze key regulatory frameworks across different countries and regions.
Identify potential challenges in complying with diverse global regulations.
Implement strategies to harmonize data disclosure practices with international standards.

Tuesday October 15, 2024 12:10pm - 12:40pm PDT

PLENARY SESSION

12:40pm PDT

JANUARY 2025: TRANSITIONING TO CTIS UNDER THE CTR

Tuesday October 15, 2024 12:40pm - 1:10pm PDT

Understand Why This Disclosure/Transparency Shift Is Critical For Your Team To Be Aware Of, and How To Effectively Transition Your Ongoing Studies To Avoid Trial Suspension and Data Risks

Understand why this shift is critical for your team to act on soon in order to ensure compliance and avoid penalties.
Maintain data integrity and minimize trial disruptions by implementing a structured transition plan.
Train your team on these new compliance requirements to foster clear communication and adaptability.

Tuesday October 15, 2024 12:40pm - 1:10pm PDT

PLENARY SESSION

1:10pm PDT

ZOOM Q&A

Tuesday October 15, 2024 1:10pm - 1:30pm PDT

Ask your questions face-to-face with the speakers you just saw.

Join a more intimate discussion post-presentation
Get your burning questions answered
Hear others thoughts on the discussion

Tuesday October 15, 2024 1:10pm - 1:30pm PDT

Q&A

1:30pm PDT

PANEL - WHAT IS TOO MUCH TRANSPARENCY?

Tuesday October 15, 2024 1:30pm - 2:30pm PDT

Discuss the Risks of Sharing Too Much Data and How to Find the Right Balance between Public Trust, Patient Protection, and Intellectual Property

Navigate the legal and ethical considerations of data distribution, and the impact that oversharing can have.
Implement frameworks for transparent communication about data sharing practices to enhance organizational reputation and stakeholder confidence.
Establish guidelines for responsible data sharing to safeguard sensitive information and enhance data security.

Tuesday October 15, 2024 1:30pm - 2:30pm PDT

PANEL

2:30pm PDT

END OF DAY ONE

Tuesday October 15, 2024 2:30pm - 2:30pm PDT

OPENING/CLOSING REMARKS