Key Sessions
Stefano Marino
An Industry Analysis on ACT-EU, the Implementation of EU CTR and CTIS Transparency Obligation
DLA Piper
keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
Day 1 – Tuesday, February 25, 2025 - ET (Eastern Time, GMT-05:00)
keyboard_arrow_leftSearch & Filter
search
Streams
Day 1 – Tuesday, February 25, 2025 - ET (Eastern Time, GMT-05:00)
search
Streams
Showing 1 of 1 Streams
Networking Break
7:45am - 8:45am
Continental Breakfast and Networking
Showing 1 of 1 Streams
General Session
8:45am - 9:00am
Conference Chair Opening Remarks
Showing 1 of 1 Streams
Regulatory Updates
9:00am - 9:45am
An Industry Analysis on ACT-EU, the Implementation of EU CTR and CTIS Transparency Obligation
Join our thought-provoking opening session with discussion on:
- The attractiveness of the European Union for clinical research after 3 years from the launch of ACT-EU: the Draghi report on competitiveness and industry's concerns
- The implementation of the Clinical Trial Regulation and its interplay with other Union and national laws (e.g. GDPR, AI act, EHDS Regulation, related EU and national guidance)
- Transparency obligations in the CTIS data base vs. protection of sponsors' IP rights
- Stefano Marino - Senior Consultant, DLA Piper
9:45am - 10:30am
Critical Updates on Policy 70
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
Showing 1 of 1 Streams
Networking Break
10:30am - 11:00am
Morning Networking and Refreshment Break
Showing 1 of 1 Streams
Clinical Trial Submissions and Registrations
11:00am - 11:45am
CTIS Updates: Navigating New Submission and Results Systems
- 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
11:45am - 12:30pm
Uncover the Latest Changes to ClinicalTrials.gov: What you Need to Know
- Explore the new PRS beta data version
- Understand master protocols and subpopulations
- Address technical issues with results system data
Showing 1 of 1 Streams
Networking Break
12:30pm - 1:30pm
Networking Lunch in Exhibit Hall
Showing 1 of 1 Streams
Data Sharing
1:30pm - 2:30pm
Building a Consistent Data Sharing Culture: From Regulation to Practice
- Explore new and innovative ways to evolve and standardize data sharing practices.
- Uncover regulatory changes on how data is protected in clinical trials
- Best practices for data sharing platforms such as:
- Outlining key strategies for preparing data for seamless anonymization
- Utilizi ngdata 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
Showing 1 of 1 Streams
Networking Break
3:30pm - 4:00pm
Afternoon Networking and Refreshment Break
Showing 1 of 1 Streams
Disclosures and Transparency
4:00pm - 4:45pm
Utilizing AI in Transforming Clinical Data Disclosure
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.
4:45pm - 5:30pm
Uncover New and Innovative Ways to Disseminating PLS to Study Participants
Engage in eye-opening discussions and strategies for managing patient facing documents. The conversation will include strategies on disseminating PLS to study participants, and ways to ensure consistency across multiple public facing documents.
- Christopher Pfitzer - Head of Clinical Trial Transparency Strategy, Biogen
Showing 1 of 1 Streams
Networking Break
5:30pm - 6:30pm
Networking Reception
Get the Latest Event Updates
Sign up to get the latest event updates and information.
Filter
Streams