EU Clinical Trials Regulation and Clinical Trials Information System
Discover an informative webinar to unravel the complexity of the Clinical Trials Information System (CTIS) and explore the regulatory structure in Europe. Most importantly, let’s 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
– Was Europe ready for CTIS?
– Did the implementation of CTIS destroy theclinical trial environment in the EU?
– Does CTIS simplify the submission process?
– Issues and improvements on the CTIS platform
Dr. Andreas Beust, CEO, GCP-Service International
Dr. Andreas Beust is Chief Executive Officer of GCP-Service International, President of the Association of International CROs (AICROS), and a passionate advocate of optimizing trial design and conduct. Andreas is intimately familiar with the requirements of clinical trials on European and international levels, both from the CRO side and by taking on sponsorship responsibility for investigator-led trials and has participated in more than 80 trials to date. As an ambassador for risk-based quality management, he focuses on consulting drug and medical device manufacturers alike on how to conduct lean, efficient trials that focus on what is important while adhering to regulatory requirements.
Dr. Jan Willem Kleinovink, Scientific staff member, CCMO (Dutch Competent Authority)
Dr. Jan Willem Kleinovink joined CCMO, the Dutch Competent Authority on clinical trials located in The Hague, after doing academic research in immuno-oncology. At CCMO, he is clinical assessor, validation team lead, and provides support and training on CTIS applications to both authority and sponsor users. In these roles, he experiences the practical and strategic challenges, but also the advantages, of the CTR and CTIS on a daily basis. He uses these experiences to advise on improvements in both the CTIS portal and in the international harmonization of validation and assessment of clinical trial applications.
So join and find out more: EU Clinical Trials Regulation and Clinical Trials Information System – Xtalks