Day One: Thursday, 7 November, 2024Thursday, 7 November 2024 - CET (Central European Time, GMT+01:00)

Hear from sponsor panelists discussing how to navigate implementing new CTIS requirements including reviewing submission content, overcome operational and timeline challenges, and harness practical strategies to streamline disclosure processes and maintain regulatory adherence.

Hear a sponsor detailing their experience adapting to new CTIS requirements, including key operational considerations, lessons learned, and workarounds discovered to increase efficiency and accuracy in disclosure reporting.

Since the introduction of EMA’s Clinical Data Publication Policy, sponsors have been grappling with a unique problem – the timely and accurate capture and protection of personal and commercial data contained in clinical trial documents. As this information is often dense, varied, and buried in lengthy unstructured text, its post-hoc protection through redaction or statistically derived transformation can pose a significant challenge.

As public document disclosure becomes an integral part of the clinical trial lifecycle, sponsors could proactively reduce this burden by incorporating best practices in writing transparency-friendly clinical documents. Join Abby McDonell, Sr. Program Manager with IQVIA’s Clinical Trial Transparency Team (powered by Privacy Analytics) to gain some actionable insights on how to optimise your medical writing processes to simplify downstream disclosure and transparency initiatives whilst ensuring participant and commercial data privacy remains protected.

• Investigate how sponsors and other companies are handling registration submission protocols for innovative study designs (like basket trials, umbrella trials, platform trials) when it comes to new EU CTR requirements (such as Annex 3)
• Discuss any changes to study endpoints for these trials and how the registration space might evolve with these complex trial designs

With over 13 Health Canada PRCI projects completed or in process, Bayer and its anonymisation partner, Real Life Sciences, will share some key learnings and takeaways including Bayer’s strategy for anonymizing Adverse Events while protecting the anonymity of trial subjects.

Discuss best practices and actionable strategies to managing compliance with the impact of EMA Policy 70, including insights on enhancing redaction and justification/redaction argumentation strategy, data anonymisation, and operational efficiency.

Examine emerging country-specific registry requirements and gain a comprehensive understanding of global regulatory updates and impact on clinical data transparency functions.

Going beyond ChatGPT, AI agent networks can work autonomously to transform all areas of clinical trial transparency. Take a detailed look at the use cases, underlying architecture and a live demo.

To secure approval from data protection authorities for post-marketing medical device studies, W.L. Gore needed to demonstrate how future study data could be effectively anonymized after the mandatory 15-year retention period. This necessitated the use of cutting-edge techniques, including advanced modeling and identifiability assessment strategies. Working with trusted partners and the Italian data protection authority, W.L. Gore successfully navigated the complexities of anonymizing data that had yet to be generated, paving the way for regulatory approval.

Join Giulia Rigodanza, Medical EMEA Data Privacy Lead from W.L. Gore; Laura Liguori, Partner at Portolano Cavallo; Eleonora Curreli, Associate at Portolano Cavallo; and Oneeb Mian, Associate Director, R&D Solutions & Customer Enablement at Privacy Analytics (moderator), for an in-depth discussion on how W.L. Gore gained approval for two critical post-marketing studies. Explore the broader implications of using AI and innovative approaches in clinical data disclosure, covering key topics such as the benefits, managing risks, and safeguarding patient privacy throughout the process.

Join forces with your industry peers to tackle the most pressing challenges in the clinical data disclosure and transparency space in this interactive roundtable session. Attendees will choose between several designated topic areas based on role or interest, and engage in focused, in-depth small-group discussions to benchmark, share common pain points, and brainstorm strategies to address these challenges. Attendees will leave this collaborative forum armed with new strategies, best practices and key takeaways specific to their area.

Topic areas will include: PLS; Registration results reporting; and Management of transparency and disclosure policies or procedures.