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2nd annual Clinical Data Disclosure and Transparency Summit has ended
strong>PLENARY SESSION [clear filter]
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Tuesday, October 15
 

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

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

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
 
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