Day One: Thursday, 7 November, 2024 - CET (Central European Time, GMT+01:00)
Day One: Thursday, 7 November, 2024 - CET (Central European Time, GMT+01:00)
- Aiko Laski - Senior Conference Producer, Informa Connect
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.
- Ritama Gupta Dempsey, PhD - Associate Director, Medical Writing and Disclosure, MSD
- Matthias Zerm, PhD - Lead Expert, Clinical Trial Disclosure and R&D Processes, Global Clinical Development, Merz Therapeutics
Hear a sponsor case study 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.
- Abby McDonell - Senior Program Manager, Privacy Analytics
- 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
- Ritama Gupta Dempsey, PhD - Associate Director, Medical Writing and Disclosure, MSD
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.
- Dr. Marion Hardtke - Head of Medical Writing Operations, Bayer AG
- Elliot Zimmerman - CEO, Real Life Sciences
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.
- Alexander Roussanov - Partner, Arnold & Porter Kaye Scholer LLP
Examine emerging country-specific registry requirements and gain a comprehensive understanding of global regulatory updates and impact on clinical data transparency functions.
- Thomas Wicks - Head of Transparency Operations, Citeline
- Examine the potential benefits of AI and large language models in streamlining the clinical trials transparency space, such as in lay person summaries, data anonymisation/unification and redactions
- Delve into risk areas and necessary guardrails to ensure sponsor use of AI is not revealing patient data, including strategies on how to optimise necessary oversight of AI
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; Redactions/Anonymisation/Document disclosure; Registration results reporting; and Management of transparency and disclosure policies or procedures
- Behtash Bahador, MS - Director, Health Literacy, Center for Information & Study on Clinical Research Participation (CISCRP)
- Christa P. Polidori, PhD - Senior Director, Clinical Transparency and Trial Disclosure, Regeneron