TBD: Strategy on Implementation of EU Clinical Trial Regulation – Lessons learned by the first submissions at Boehringer Ingelheim
Poster Presenter
Petra Bettendorf
Head of Regulatory Affairs Region
Boehringer Ingelheim International GmbH Germany
Objectives
Share the experience of the implementation of the EU CTR at Boehringer Ingelheim. Give an overview on the staggered approach of submitting pilot studies in the transition period until 31.01.2023.
Method
The Clinical Trial Regulation (Regulation (EU) No 536/2014)* simplifies the application process and increases transparency of clinical trials in the EU. It aims to harmonize the preparation, submission, review of clinical trial applications (CTAs) and the conduct of clinical trials. It applies to all interventional clinical trials regardless of whether conducted in one or several EU Member States.
As of end of January 2022 (EU wide harmonized) CTA dossiers can be submitted via Clinical Trials Information System (CTIS), a new single EU portal/database overseen by the EMA. Submission will be followed by a collaborated assessment conclusion and decision for both Health Authorities (HAs) and Ethic Committees (ECs) within the EU via CTIS. The one-year transition period started on 31 January 2022 and will end on 31 January 2023. During this period, Boehringer will run pilots under the umbrella of the new regulation. The Regulation also defines harmonized criteria for authorization process, safety reporting, labelling requirements and transparency/publication rules throughout the EU.
In this presentation on we share our approach to implement the Clinical Trial Regulation in a structured and pragmatic way within the cross-functional team at Boehringer Ingelheim to efficiently manage and leverage the new opportunities of the harmonized EU process. Corresponding to the presented approach, we will outline lessons learned and future outlook of the efficient management of Clinical Trials under EU CTR.
*https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation
