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2nd annual Clinical Data Disclosure and Transparency Summit
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Tuesday, October 15
 

11:00am PDT

OPENING REMARKS
Tuesday October 15, 2024 11:00am - 11:10am PDT
Speakers
EK

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
Tuesday October 15, 2024 2:30pm - 2:30pm PDT
  OPENING/CLOSING REMARKS
 
Wednesday, October 16
 

11:00am PDT

OPENING REMARKS
Wednesday October 16, 2024 11:00am - 11:10am PDT
Speakers
EK

Emma Kindsvatter

Director of Content and Experience, MOMENTUM EVENTS
Wednesday October 16, 2024 11:00am - 11:10am PDT
  OPENING/CLOSING REMARKS

11:10am PDT

THE ROLE OF AI
Wednesday October 16, 2024 11:10am - 11:40am PDT
Demonstrate the Value of AI and Machine Learning to Optimize and Streamline Data Disclosure Processes, and also the Risks and Potential Negative Outcomes
  • Discover how AI and machine learning can streamline data disclosure processes, improve efficiency, and reduce manual effort.
  • Identify potential risks associated with AI and sensitive patient information to enable proactive mitigation strategies.
  • Gather predictions for the future impact of AI on clinical data disclosure.
Wednesday October 16, 2024 11:10am - 11:40am PDT
  PLENARY SESSION

11:40am PDT

EFFECTIVE COMMUNICATION WITH PLAIN LANGUAGE SUMMARIES
Wednesday October 16, 2024 11:40am - 12:10pm PDT
Understand the Powerful Impact of Accessible Communication Strategies, and How To Craft Summaries Carefully To Make Sure You Are Providing Accurate Information
  • Evaluate the effectiveness of your communication strategies to refine and optimize information dissemination.
  • Simplify complex information without losing essential details, making it easier for stakeholders to grasp critical points.
  • Tailor your summaries to meet the needs of different stakeholders, improving relevance and usability.
Wednesday October 16, 2024 11:40am - 12:10pm PDT
  PLENARY SESSION

12:10pm PDT

CASE STUDY - PARTICIPANT DATA RETURN
Wednesday October 16, 2024 12:10pm - 12:40pm PDT
Learn How Pfizer Is Spearheading Health Equity Through Their Participant Data Return, and Why It’s Vital To The Future of Data Transparency
Speakers
avatar for J.R. Meloro

J.R. Meloro

Head, Global Transparency, PFIZER
Wednesday October 16, 2024 12:10pm - 12:40pm PDT
  PLENARY SESSION

12:40pm PDT

ZOOM Q&A
Wednesday October 16, 2024 12:40pm - 1:00pm 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
Wednesday October 16, 2024 12:40pm - 1:00pm PDT
  Q&A

1:00pm PDT

PANEL - USING NEW TECHNIQUES FOR DATA SHARING BEST PRACTICES
Wednesday October 16, 2024 1:00pm - 2:00pm PDT
Unveil What New and Buzzworthy Innovative Practices Are Working (and Not Working) In Clinical Data Disclosure To Set Your Team Up For Trustworthy Transparency
  • Understand the importance of adopting new techniques into your data sharing practices, and the impact it has on your disclosure and transparency efforts.
  • Highlight common objections and roadblocks found when adopting new techniques and technologies into your practices, and how to mitigate those.
  • Gather realistic steps of how to implement new practices into your team's work.

Speakers
avatar for Oladayo Oyelola

Oladayo Oyelola

Senior Director and Head,Clinical Trial Information Disclosure, DAIICHI SANKYO
Wednesday October 16, 2024 1:00pm - 2:00pm PDT
  PANEL

2:00pm PDT

CLOSING REMARKS/END OF CONFERENCE
Wednesday October 16, 2024 2:00pm - 2:10pm PDT
Wednesday October 16, 2024 2:00pm - 2:10pm PDT
  OPENING/CLOSING REMARKS
 
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Tuesday, October 15
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