EU Clinical Trial Regulation: Latest Developments and Upcoming Opportunities

The EU clinical trial landscape has changed significantly since Regulation (EU) No 536/2014 became applicable on January 31, 2022, and sponsors now need a clear view of how the framework is operating in practice and where it may evolve next. This webinar explores the current status of clinical trial regulation in the EU, including experience with Clinical Trial Information System (CTIS), updated transparency expectations and emerging regulatory developments.

Since CTIS launched, nearly 13,000 initial applications have been submitted, giving sponsors substantial experience with the benefits and challenges of a more harmonized system, a centralized submission portal and revised transparency rules. Key guidance materials, including the CTIS Sponsor Handbook and related support resources, continue to be updated, with a further handbook update published in March 2026.

The webinar will examine the European Commission’s Biotech Act proposal, published on December 16, 2025, and its potential implications for the future EU clinical trial framework. Topics include reduced assessment timelines, parallel substantial modifications, new trial categories, dossier and Member State concepts, emergency procedures and combined trial pathways through CTIS.

Attendees will gain practical context on current submission and transparency expectations, ongoing operational challenges and potential future opportunities in the evolving clinical trial regulatory environment in the EU.

Register for this webinar to learn how clinical trial regulation is evolving across the EU and what these changes could mean for trial submission, transparency and future planning.

Speakers

Pierre-Frédéric Omnes, Executive Director, TransPerfect Life Sciences

Pierre-Frédéric Omnes is an Executive Director at TransPerfect Life Sciences with over 23 years of experience in global CROs and pharmaceutical companies as a Regulatory Affairs Consultant. He is a Subject-Matter Expert (SME) in regulatory operations for global clinical trials, as well as in the EU Clinical Trial Regulation 536/2014 (EU CTR) and its Clinical Trial Information System (CTIS) for corporate readiness and implementation support. Pierre has been part of the EMA-led initiative to develop the EU CTIS as an SME representing industry and academic sponsors since 2019, and has continued to participate in testing and workshops with the EMA and other stakeholders for several years.

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Gabriella Di Matteo, EU CTR Advocacy Lead & Strategic Execution, Pfizer

Gaby Di Matteo is the EU CTR Advocacy Lead and Strategic Execution Lead at Pfizer, based in Brussels. She leads EU-level advocacy and strategic engagement on the EU Clinical Trials Regulation (536/2014) and the Clinical Trials Information System (CTIS) at Pfizer and works closely with regulators, industry associations and global teams. With more than 30 years of experience in early development and regulatory affairs, Gaby has been a CTIS Subject-Matter Expert since 2019, bringing an operational sponsor perspective to regulatory and policy discussions. She actively supports industry alignment through coordinated positions to improve the effectiveness, predictability and sustainability of the EU clinical trials framework.

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Scott Feiner, Senior Manager, Trial Disclosure, AbbVie

Scott Feiner has 17 years of experience in clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, and later operating within larger organizations, where he served as an expert in summary results reporting and clinical document redaction and anonymization for public disclosure. Since 2021, Scott has focused on CTIS and the EU CTR, and since 2024 has served as one of six EMA-designated industry Subject-Matter Expert for CTIS.

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Andrea Seidel-Glätzer, Director KKS Network Office, KKS Network

Andrea Seidel-Glätzer serves as the Director of the KKS Network Office as of May 1, 2026, where she is responsible for the strategic coordination and further development of national structures supporting academic clinical research. The KKS Network is an association and nonprofit organization of academic coordinating centers for clinical studies in Germany. Before joining the network, she headed the Project Management Unit at the Clinical Trials Center (KKS) of Heidelberg University, overseeing various academic multicenter clinical studies. Since 2020, she has served as a Subject-Matter Expert for the Clinical Trials Information System (CTIS) and as a member of the CTIS Simplification Task Force at the European Medicines Agency, representing academia.

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