Navigating the EU Clinical Trial Regulation Complexities: Current Challenges and Opportunities

Life Sciences, Clinical Trials,
  • Tuesday, March 07, 2023

As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU Clinical Trial Regulation became compulsory for all new interventional clinical trials of investigational medicinal products. All ongoing trials approved under the previous regulatory framework (EU Clinical Trial Directive 2001/20/EC) in the scope of the EU CTR will have to end or transition to comply with the new regulation by January 31, 2025. In that context, sponsors and clinical trial applicants need both internal readiness of their organization as well as expansion of EU CTR for new and ongoing studies (at least for those not ended by early 2025) in order to prepare for its multiple operational impacts. For optimal EU CTR readiness, the following points must be considered:

  • Assessing EU CTR’s impact on the organization and planning readiness strategies based on the development portfolio (ongoing and planned)
  • Managing submission activities using the new EU Portal, Clinical Trial Information System (CTIS), while accounting for evolving transparency rules
  • Optimizing translation management for expedited handling of ethics/regulatory queries (up to 12 calendar days turnaround time)
  • Piloting studies under EU CTR to confirm/adjust implementation strategies as needed
  • Developing/evolving transparency strategies regarding the disclosure principles applied with EU CTR including authoring, redacting and deferring setup for study documents submitted or to be generated at the end of the trial
  • Updating standard operating procedures (SOPs) and work instructions for those matters affected globally by this regional regulation, including the impact on external vendors contracted for clinical-trial-related activities
  • Training teams to evolve their operational practices (clinical, medical, regulatory, transparency, etc.) to the new EU regulatory framework


With over three years of engagement in the development of the Clinical Trial Information System as Product Owner for the sponsor and academia sponsor, the featured speaker will take the opportunity of this first milestone in the EU Clinical Trial Regulation transition to review current and future challenges and opportunities related to EU Clinical Trial Regulation implementation both on a readiness and operational execution standpoint for industry sponsors of clinical trials involving one or more countries in EU/EEA.

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Join this webinar to learn more about navigating the EU clinical trial regulation complexities.



Gaby Di Matteo, Director, Clinical Trial Regulatory Operations Team Manager, Pfizer Global Regulatory Sciences

Gaby Di Matteo has been working in early clinical research and regulatory submissions for more than 25 years and has participated in the evolution from pre-CTD to CTR implementation. She manages Clinical Trial Submissions Managers who submit trials in Europe and in CTIS.

Gaby is a member of Pfizer workstreams implementing EU CTR and tester of the portal since UAT 1 in early 2016. She is also a member of Sponsor PO group since 2019.

Message Presenter

Samia Dridi, Clinical Trial Regulatory Lead, Roche

Samia Dridi is a Clinical Trial Regulatory Lead at Roche. She joined Roche in 2011 where she pursued her passion for innovation in healthcare, wherein as a Regulatory Submissions Manager, she developed a keen interest in clinical development.

Samia managed multiple clinical trials submissions, initial marketing applications and post-approval activities across the portfolio. Her dedication to learning and sharing knowledge has driven her participation in cross-functional initiatives, industry forums and health-authority interactions.

Over the past few years, she has been gaining further experience in clinical development since joining the Clinical Trial Regulatory Management team and is passionate about helping patients.

Message Presenter

Pierre-Frédéric Omnes, Executive Director, TransPerfect Life Sciences

Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, has over 20 years of experience in global CROs and pharma companies as a regulatory affairs consultant overseeing numerous multinational clinical trial applications globally. Pierre is a subject-matter expert on site startup and regulatory operations in global clinical trials as well as on the EU Clinical Trial Regulation 536/2014 (EU CTR) for corporate readiness, implementation and Clinical Trial Information System.

Pierre is part of the EMA-led initiative developing the EU Clinical Trial Information System (CTIS) as Lead Product Owner representing the Industry & Academia since 2019, continuing an engagement of several years in user acceptance testings, workshops and analysis & design sessions related to CTIS development and optimization.

Message Presenter

Andrea Seidel-Glaetzer, MA, RN, Head of Project Management, Coordination Centre For Clinical Trials Heidelberg (KKS), Germany

Andrea Seidel-Glaetzer joined the Coordination Centre for Clinical Trials at University Hospital Heidelberg (KKS) as a Project Manager more than 12 years ago. She also has prior experience working in the pharmaceutical industry and a CRO.

The KKS acts as a kind of CRO and mainly supports investigator-initiated clinical trials in academic institutions and smaller industries. Since March 2020 Andrea joins EMA’s Clinical Trials Information System testing as a representative of the academia on behalf of ECRIN.

Message Presenter

Jim Armbrust, Head, Clinical Trial Transparency & Disclosure Office, Alexion Pharmaceuticals

Accountable for any and all legally required or policy driven transparency requirements for the Alexion Group of Companies. I create sustainability and a reduction in risk footprint by a strong focus on corporate executive leadership representation, issue mitigation and resolution through consistent dependable support, advice and execution of deliverables in the best interest of stakeholders and the Company. Including all US/Ex US Registries compliance, Data Privacy including sharing, EU/EMA Clinical Trial Regulations (Clinical Trial Information System ((CTIS)) all clinical anonymization needs including redactions, 21Part11 compliant certified system enablement including anonymization software. Jim’s niche is legally driven disclose needs.

Message Presenter

Who Should Attend?

CEOs, CIOs, Presidents, VPs, directors, and managers involved in:

  • Clinical Trials
  • Clinical Operations
  • Clinical Disclosure and Transparency
  • Clinical Development
  • Regulatory Affairs
  • R&D

The session will be especially useful for those working on interventional clinical trials involving one or more EU/EEA countries.

What You Will Learn

Attendees will learn:

  • A deeper understanding of the practical impacts of the transition to the EU Clinical Trial Regulation for clinical trial execution
  • How to best prepare for these impacts from a company readiness or study execution standpoint

Xtalks Partner

TransPerfect Life Sciences

TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. For more information, please visit our website at

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