The new EU Clinical Trials Regulation (CTR) aims to create a more favourable environment for research in Europe, as well as maintain the highest level of standards for patient safety, and increased transparency of clinical trial information.
With any new regulatory review process there can be a period of adjustment as sponsors become accustomed to the new procedures and timelines. During this webinar we will outline the EU CTR process, sharing our experience of early phase trial submissions so far. We will offer insights into where efficiencies can be gained, pitfalls to avoid, and how you can work together with your CRO to leverage the EU CTR as an opportunity to improve processes, whilst complying with legal responsibilities.
Points for discussion will include:
- Overview of the new EU CTR regulatory review process in Europe– identifying the key differences and implications for your early phase study
- The efficiencies achieved within the EU CTR and Netherlands regulatory framework, streamlining early phase trial approval under both sponsor and CRO submission models
- Examples of both full regulatory support and hybrid models we have used to complete submissions in CTIS under the EU CTR
- Submission lessons learned and timeline to approval data based on our experience so far.
Director, Regulatory Affairs (ICON)
Vicki is an experienced regulatory professional with over 20 years in the pharmaceutical industry/clinical research organizations. She has experience in managing clinical trials with a strong focus on building and maintaining relationships at both company and industry level from an operational role within the organization. Since July 2020 Vicki has been part of the EMA sponsor stakeholders for the Clinical Trial Information System (CTIS) and supported with the development of functionalities and testing. As one of ICON’s EU CTR subject matter experts she co-led implementation of the EU CTR in ICON.
Dr. Emma Meijer
Director, Project Management (ICON)
Emma is an experienced clinical research management professional with over 15 years of experience in the management of regulatory submissions for clinical research. She oversees the project management of regulatory submissions under EU CTR at ICON, supporting sponsors to make the process as smooth and efficient as possible.
Pharma/Biotech/medical device companies looking to place clin pharm trials with ICON at EU sites.