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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The new EU Clinical Trials Regulation (CTR) was published in 2014, became applicable in all member states Jan 31 2022 and from Jan 31 2023 is mandatory for all new EU clinical trials (CTs). The EU CTR harmonises clinical trial applications in Europe and aims to deliver greater public transparency around CTs in Europe and create a favourable research environment in Europe by reducing administrative requirements on CTAs and streamlining workflows.
The changes introduced in the CTR are broad, and require industry CT sponsors, CROs and Regulatory Agencies to approach CT applications differently, including submission via the new Clinical Trial Information System (CTIS). CTIS is a single online portal through which clinical trial sponsors and other organisations involved in running clinical trials will submit data related to a trial and post-trial results.
The session will begin with a brief overview of the changes introduced in the Clinical Trials Regulation, followed by sharing of implementation experiences of Industry CT sponsors, CROs & Agencies. The audience will then have the opportunity to exchange experiences around implementation and use of the CTIS and pose questions to the speaker panel to ensure readiness for implementation in January.
€ 0 Member
€ 25 Nonmember
Regulatory professionals involved in clinical trials in Europe and/or those seeking to learn more about the new EU Clinical Trial Regulation.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Kate Stockman PhD FROPRA, OTC Category Lead, Senior Director, Haleon
Kate Stockman PhD FTOPRA is an experienced Regulatory leader with >20 years of experience working in regulatory affairs across the pharmaceutical, generic and consumer healthcare sectors. She has extensive product development experience (from concept and early clinical development through to registration and post-launch life-cycle management) of Rx & OTC medicines, medical devices, dietary supplements, cosmetics & herbal medicines. Kate represents the pharmaceutical sector on the RAPS EU Council and has had practical experience with EU CTR implementation planning as the co-sponsor for Haleon's EU CTR compliance program.
Charlie Bergqvist, Director, Syneos Health Consulting
Charlie is a trusted advisor to Pharma R&D leadership teams, with >7 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 & implementation across R&D functions, with key expertise in patient centricity & 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 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 in the challenges faced by organizations preparing for EU CTR compliance.
Kirsten Messmer PhD, RAC, Senior Research Analyst, Agency IQ
Kirsten Messmer, PhD, RAC is a Senior Research Analyst and contributes to the research and development of content for Agency IQ on regulatory issues for the United States and European Union. Prior to joining Agency IQ, she was a Principal Regulatory Affairs Specialist at PPD providing global regulatory intelligence to support efficient, compliant and successful clinical research and drug development for biopharmaceuticals and advanced therapies. Before starting at PPD, Kirsten worked at Theradigm to develop stem cell therapies for neurodegenerative diseases before joining ERA Consulting. She held post-doctoral fellowships in London and Baltimore. Kirsten received her PhD in Neuroscience from the University of Sheffield, UK and a Biology Diplom from the Eberhard-Karls University (Tubingen, Germany). Kirsten also holds a Regulatory Affairs Certification (RAC) in US regulation.
Lene Grejs Petersen, Senior Adviser, Danish Medicines Agency, Clinical Trial Unit
Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) member since 2008 and is the Danish representative of the EU Commission’s expert group concerning clinical trials (CTEG) since 2001 and Clincal Trials Advisory Group since 2022. Lene has been an employee at the Danish Medicines Agency since 2000 and she has been involved in the implementation of the EU Clinical Trials Regulation and works as a regulatory assessor and coordinator of clinical trials. Lene has a background as Master in Pharmacy.
Noémi Manent, Principal Scientific Administrator, Data Analytics and Methods Task Force European Medicines Agency
Noémie Manent joined the European Medicines Agency EMA in March 2011 as a Principal Scientific Administrator in the Compliance and Inspection Sector. She is a member of the Data Analytics and Methods Task Force and is involved with the implementation of the Clinical Trial Regulation No. 536/2014. She is the Operations Workstream Lead for the Clinical Trial Information System enabling the application of the Clinical Trial Regulation.
Pierre-Frédéric Omnes, Executive Director at 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 Regulatory Affairs consultant overseeing numerous multinational clinical trial applications globally. Pierre is a subject matter expert on Site Start up and Regulatory Operations in global clinical trials as well as on the EU CTR 536/2014 for corporate readiness, implementation and Clinical Trial Information System.
Pierre is part of the EMA-led initiative developing the CTIS as Lead Product Owner representing the Industry & Academia, continuing his engagement of several years in User Acceptance Testings, Workshops and Analysis& Design sessions related to the system development.
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