The European Union Clinical Trial Regulation (EU CTR) is the largest change in the EU clinical trial landscape in 20 years. This year marks the beginning of a three-year transition period during which companies need to implement updated processes and assess systems to enable compliance and effective Clinical Trials Information System (CTIS) interfacing. Companies wanting to run future interventional medicinal trials in the EU now more than ever need to ensure that their readiness programs are prioritized.
The following six major changes mandated by CTR are significant and require processes and systems across sponsors and CROs to be adapted to ensure compliance:
- Clinical Trial Application (CTA) submission to all member states is now done through CTIS, with 12-day RFI (request for information) response times and new constraints to submission modifications
- New labelling requirements for IMP (Investigational Medicinal Product)
- Increased transparency requirements that impact disclosure of commercial confidential information and protected personal data
- Increased clinical trial notifications requirements
- New safety reporting requirements and timelines
- CTIS interaction
Join this webinar as EU CTR experts discuss these challenges and the innovative process design, technology and outsourcing solutions available.
Fabienne Lekaim, PhD, Director, Regulatory Advice and Delivery (RAD) Team — SSU Early Engagement, Syneos Health
Fabienne Lekaim Allouche brings a unique regulatory breadth of operational experience, global leadership and data-driven approach to management and decision-making process resulting in a record of delivering results in dynamic environments. Fabienne’s career started in global regulatory affairs, as a PhD Regulatory Project Coordinator in an orphan drug laboratory and then joined in Syneos SSU Regulatory Department in 2011. She has led multiple international projects involving various type of design (First in Human, complex protocol design, COVID-19 accelerated protocol platform trials), test products (such as advanced therapy medicinal products consisting of genetically modified cells generated) and borderline products (such as combined test product using medical device) in various countries.
In the past few years, Fabienne actively contributed to the creation of the Operational Regulatory Advice and Delivery (RAD) Team to deploy regulatory risk operational guidance on projects. She also collaborated with the EU CTR (European Union Clinical Trial Regulation) Corporate SBI sharing readiness and strategic insights and developed the SSU’s modular operating model specific to EU CTR submissions. Passionate and engaged in patient diversity and equity, Fabienne supports early project protocol reviews promoting equity by design, regulatory clinical trial submission risks (viability) and recommendation to many stakeholders and clients.
Peter Sargent, PhD, Director, R&D Advisory, Syneos Health
Peter Sargent brings 17 years of experience working within pharmaceutical and life science industries since his PhD in Biochemistry. He has broad experience working across R&D, operational and commercial functions within a wide variety of organisations, including industry and government. He currently works within Syneos Health’s R&D Advisory Team, supporting biopharma (emerging to top-tier) across their R&D with organisational, process and technology transformation. Over the last year, he has supported a wide variety of global biopharmaceutical and consumer health companies with their EU CTR Readiness programmes.
Charlie Bergqvist, Senior Engagement Manager, R&D Advisory, Syneos Health
Charlie is a trusted advisor to Pharma R&D leadership teams, with more than six years’ experience as a strategic consultant to emerging Biopharma and top-tier Pharma organizations. Charlie brings a wealth of experience in organizational and operating model design and implementation across R&D functions, with key expertise in patient centricity and diversity through development of patient engagement plans. Charlie is a Prosci Certified Change Practitioner with experience in managing transformational change, ensuring that key drivers of change are clearly communicated and relatable to the impacted stakeholders. Over the last few years, Charlie has focused on collaborating with clients to drive readiness for EU CTR, supporting organizational capability assessments and establishing and embedding EU CTR compliant processes across CTA submission through to safety reporting. Charlie has a deep understanding of the challenges faced by organizations preparing for EU CTR compliance.
Sherry Merrifield, Senior Director, Global Operations Management, Syneos Health
Sherry Merrifield is a Sr. Director of Global Operations Management at Syneos Health. She has held senior management positions in both clinical operations, monitoring and regulatory affairs, with over 20 years of experience across clinical roles. Currently, Sherry is responsible for leading strategic business change initiatives, including Syneos Health’s Clinical Development readiness solution for the EU CTR. Most recently, she directed the global program and implementation of a risk-based approach to the design and delivery of clinical trials in support of ICH E6. Sherry is an active member of the ACRO CRO Forum, holds a yellow belt in Lean Six Sigma and has presented clinical operations and monitoring topics at multiple industry meetings.
Fatima Pimentel, Associate Director, Site Start-Up & Regulatory, Syneos Health
Fatima Pimentel joined Syneos Health in October 2021 as an Associate Director, Site Start-Up & Regulatory. She is also responsible for the training and development of the new CTIS Portal Team.
Fatima has over 16 years of experience as a Regulator in the Portuguese Competent Authority and as an Expert Representative of EMA in several Clinical Trials Groups. She was also a member of CTFG from 2008 – 2021
Fátima Pimentel studied Industrial Pharmacy and obtained a POS-degree in Clinical trials Monitoring. Worked in INFARMED since 2005-2021, in the Clinical Trials Unit, her roles were as a senior Clinical trials coordinator, especially in the VHP procedure, coordinator for technical and regulatory support to academic trials submissions, participant in the Portuguese regulatory and scientific advice for Clinical Trials discussions, coordinator of the Portuguese national electronic platform for clinical trials submissions (RNEC).
Fatima joined the EMA-CTIS project almost since the beginning, having a role as a Member State Product Owner for the CTIS project, an expert for the EMA training team and a role as a Master Trainer for PT and collaborating in the Sponsor’s trainings. She has been active in several communications and training’s related with Clinical trials submissions in different forums and being a trainer in the DIA/EMA CTIS trainings.
Who Should Attend?
This webinar is for biopharmaceutical leaders who are involved in:
- Clinical Operations
- Regulatory Affairs
- Clinical Stage Companies
- Running trials in the EU or interested in doing so
What You Will Learn
In this webinar, attendees will:
- Understand the significant changes the new EU CTR (The European Union Clinical Trial Regulation) will bring to how clinical trials are conducted in the EU
- Discuss how companies can adapt their processes and systems to these new systems in order to comply
- Learn which innovative process and technology solutions can help them achieve readiness success
Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com.