Expert Insights Webinars
EU CTR Compliance and Success:
Navigating Updates and Preparing Submissions for the EU CTIS Portal
June 20, 2023 9:00-10:00 AM EST
What You Will Learn
As of January 31, 2023, Sponsors are required to submit all new trial applications for authorization in the European Union through the Clinical Trial Information System (CTIS) in compliance with the new European Union Clinical Trials Regulation (EU CTR). With the new regulation, Sponsors are seeking guidance with questions such as: what types of documents to include, processes, timelines, and how to protect confidential information, among others. Not fully understanding the process could result in releasing unprotected data or withdrawing the application due to unmet deadlines and requirements.
In this webinar, a cross-functional team, including clinical trial transparency specialists and medical writers, will share best practices and insights to help Sponsors better prepare their submissions for the EU CTIS portal.
Attendees will learn about:
- Protection of Personal Protected Data (PPD) and Company Confidential Information (CCI) through redaction
- Lessons Learned through RFI requests
- Translation requirements of Part 1 and Part 2 Documents
- Deferred and Non-deferred documents and the consideration of longstanding and temporary CCI
- Relaunch of Policy 0070 and its impact on CTIS
- New document types, such as Plain Language Protocol Synopsis (PLPS)
- How to transition trials that were started under the former Clinical Trials Directive through EudraCT to CTIS
- Benefit of early involvement of transparency expertise
Who Will Benefit from Attending?
- Regulatory Affairs and Submissions Professionals
- Clinical Trial Transparency and Disclosure Professionals
- Pharmaceutical and Academic Professionals
Gina Bennett is a Senior Clinical Trial Transparency Specialist I, with many years of teaching and regulatory transparency and disclosure experience. She has over 4 years’ experience in Regulatory Transparency and Disclosure. She brings hands-on experience through client consultation and project management while leading an international team through both EMA Policy 0070 and Health Canada PRCI redaction and anonymization regulatory requirements with varied sponsors and their clinical publication submissions.
Dr. Arshi Muhibulla Ghousia is a Team Lead, Regulatory and Medical Writing with 11 years of experience in medical writing. Dr. Ghousia holds a Post Graduate Diploma in Clinical Research and Pharmacovigilance from ICBio, Bangalore and Bachelors in Dental Surgery from Rajiv Gandhi University of Health and Sciences, Bangalore.
Utkarsh Suhas Bartakke is a Clinical Trial Transparency Specialist. Mr. Bartakke has completed his Master of Pharmacy from Pune University. He holds over eight years of experience in pharmacovigilance, narrative writing, redactions/ anonymization, and clinical trial maintenance.