Date: 15th April 2024
Time: 14:00 - 15:00 (GMT)
Webinar overview
This webinar will be a showcase for three CTD-CTR transitional application experiences from small, mid-size and large organisation sponsors. Considerations for strategic planning and post-transition substantial modifications will be discussed. Lessons learned and opportunities for sponsors as well as suggestions to regulators for further improvement of the EU regulatory system will be open for debate.
Learning outcomes
• Awareness of the benefits to joining TOPRA’s SPIN groups and how to join the Clinical Trials SPIN Group
• An understanding of the requirements of the regulatory framework for Directive to Regulation transitional trials
• Insights into how sponsors are managing transitional clinical trials
• Strategies for ensuring compliance and best practices in navigating regulatory challenges.
• Pragmatic guidance on the impact to transparency
• Q&A sessions for participants to address specific concerns and receive expert clarification.
Audience
This online event suitable for stakeholders who work in the pharmaceutical and biotechnology industries, from small to large size companies, with offices based in Europe, the United States, Japan, Australia, New Zealand, Latin America and Canada.
Speakers
Christine Grew
Dr Christine Grew MBA is a global regulatory affairs professional with over 20 years of wide-ranging drug development experience gained from leading regulatory projects for small and large pharma/biotechs/CDMOs and through regulatory consultancy practice. When the EU CTR was first issued in 2014, Christine was tasked with leading regulatory readiness activities for 150+ clinical trials and represented EFPIA & EuropaBio at EMA stakeholder meetings for the development of CTIS. In her current role as Director of Regulatory Affairs at Canopy Life Sciences, Christine supports clinical trial sponsors with EU CTR readiness activities and with strategic and operational aspects of EU CTR implementation. Christine currently serves as the co-chair of the TOPRA Clinical Trials SPIN and is a working party member and Day Chair of TOPRA’s Introduction to Regulatory Affairs Programme.
Elmira Vural
Elmira Vural, Senior Manager of Regulatory Affairs at Alnylam UK, has extensive experience in working within CTIS and supporting the implementation of the EU CTR. Her expertise includes leading global regulatory strategies, handling filings and post-approval activities across multiple regions, providing strategic advice, mitigating regulatory risks, coordinating submissions and responses to regulatory authorities, and serving as a critical liaison between internal teams and external partners. Elmira holds a Bachelor of Science in Biology and a Master of Science in Drug Regulatory Affairs. She combines academic knowledge with practical experience and has previously held roles at Fortrea and IQVIA.
Pierre-Frédéric Omnes
Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, is a regulatory affairs pharmacist with 21 years of experience in global Clinical Research Organisations and the Pharmaceutical industry as a Regulatory Affairs consultant (clinical trial regulatory operations). For 15 years, Pierre supported the coordination, support and oversight of numerous multinational clinical trial applications globally for New Chemical Entities, Biologics and Advanced therapies across several therapeutic areas. More recently, Pierre supported readiness activities around EUCTR implementation as EUCTR subject matter expert both within his company (department- and corporate-levels) and externally as consultant in EUCTR implementation initiatives for small, mid-size and large pharma and CROs. Since July 2019, Pierre is part of the EMA-led initiative developing the Clinical Trial Information System as Lead Product Owner representing the Industry and Academia stakeholders in that project, continuing an engagement of several years in the testing and optimization of CTIS.
Leoni Mahal
Leoni is a regulatory professional at Achilles Therapeutics, a biotechnology company developing an autologous T-cell immunotherapy. Over the past four years, she has gained experience working with an investigational ATMP (cell therapy) by supporting its global clinical development programme as well as leading the transition of its early-phase clinical trials to the new EU-CTR. In addition to her regulatory work, Leoni is currently completing TOPRA’s Regulatory Affairs Specialist Level 7 Apprenticeship. She is also a member of the TOPRA Clinical Trials and Biotechnology SPINs. Prior to working in Regulatory Affairs, Leoni graduated from Royal Holloway University of London with a BSc in Biochemistry. She then completed her MSc in Biological Sciences by Research, where she investigated a long-term gene therapy treatment strategy using recombinant AAV vectors.
Chris Price
Chris Price is an Associate Director, Regulatory Strategy in Global Regulatory Affairs Oncology at Merck Healthcare in Darmstadt Germany. He has built up more than 15 years of EU and global experience in clinical strategy and dossier management in several global biopharma companies and also at CROs. Chris was co-lead at Merck for implementation of CTR processes. Until paternity leave in March 2020 Chris represented EFPIA in the Clinical Trials Information System (CTIS) Process Owners group, which is working in close collaboration with the EMA, European Commission and the Member States on developing a fully functional system. Chris is currently co-chair of the clinical trials special interest network at TOPRA. In 2023 he was awarded Fellow of TOPRA.
Non-Member: £114 (Excluding VAT)
Member: £70 (Excluding VAT)