In this free webinar, unravel the complexity of the Clinical Trials Information System (CTIS) and explore the regulatory structure in Europe. Attendees will learn about the intricacies and complexities associated with CTIS. The featured speakers will discuss whether these recent regulatory changes still position Europe as a leading choice for conducting clinical trials.
TORONTO, Nov. 9, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar to unravel the complexity of the Clinical Trials Information System (CTIS) and explore the regulatory structure in Europe. Most importantly, the featured speakers will discuss whether all the latest changes in the regulatory landscape still position Europe as the number one destination for clinical trials.
The implementation of the clinical trial regulation 536/2014 (Regulation (EU) No 536/2014, on January 31, 2022, was aimed at making the European Union (EU) a more attractive destination for pharmaceutical research and development. But is this the current status for EU manufacturers? This regulation focuses on harmonizing processes of clinical trials including submission, application for authorization, evaluation and supervision of clinical trials within the EU and the European Economic Area, thereby increasing transparency towards the public and providing a common database for regulators. Sponsors of clinical trials are now required to submit their trial via the CTIS portal for regulatory oversight of the trial, tools and monitoring of the trial.
However, since the implementation of CTIS, manufacturers have faced new challenges and regulators are overwhelmed with its complexity.
As a clinical research organization (CRO) that is also able to take over the role of a sponsor for clinical trials, GCP-Service has experienced CTIS firsthand.
Join this webinar to gain insights into:
- The complexity of CTIS
- If Europe was ready for CTIS
- If the implementation of CTIS destroyed the clinical trial environment in the EU?
- If CTIS simplifes the submission process
- Issues and improvements on the CTIS platform
Join Dr. Andreas Beust, CEO, GCP-Service International; and Dr. Jan Willem Kleinovink, Scientific staff member, CCMO (Dutch Competent Authority), for the live webinar on Wednesday, November 29, 2023, at 9:30am EST (3:30pm CET/EU-Central).
For more information, or to register for this event, visit EU Clinical Trials Regulation and Clinical Trials Information System.
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