Day 1 – Tuesday, February 25, 2025 - ET (Eastern Time, GMT-05:00)
Dive into the latest shifts in Policy 70 and discover how sponsor companies are adapting to these pivotal changes. Join us for an in-depth exploration of the key updates and what they mean for your organization moving forward.
- Alexander Roussanov - Partner, Former EMA
Get ready for the next chapter! Join us as we explore strategies in uncovering ways to successfully accommodate changes in sharing IPD.
- Clarify recent updates to submissions and results to clear up confusion on how the new results system will be set up.
- Explore effective strategies in lieu of clear EMA guidance.
- Dive into best practices for tracking interim results.
- Kristina Wang - Data Disclosure & Transparency Specialist, BeiGene
- Alice Smith - Associate Director, Eli Lilly and Company
- Veronique Stonnet - Senior Trial Disclosure Manager, Sanofi
- Explore the new PRS beta data version
- Understand master protocols and subpopulations
- Address technical issues with results system data
- Explore new and innovative ways to evolve and standardize data sharing practices
- Uncover regulatory changes on how data is protected in clinical trials
Outline key strategies for preparing data for seamless anonymization
Utilize data sharing to strengthen clinical trials on underrepresented areas such as rare disease data
- Obaraboye Olude - Clinical Trials Transparency Manager, Privacy Analytics
- Jennica Young - Associate Director, Clinical Trial Transparency, Alexion
- Rebecca Li - CEO, Vivli
- Karla Childers - Head, Bioethics-based Science & Technology Policy, Johnson and Johnson
Don’t miss our dynamic panel discussion as industry leaders share diverse perspectives on how AI is revolutionizing clinical data disclosure and reshaping day-to-day operations across the industry.
Engage in eye-opening discussions and strategies for managing information data in the public domain to ensure accuracy. Delve into strategies on disseminating PLS to study participants, and gain insights on the vital role patient organizations play in this process.
- Christopher Pfitzer - Head of Clinical Trial Transparency Strategy, Biogen