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

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.

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.

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.

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.

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.