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
Speakers
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.
Message Presenter
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.
Message PresenterWho Should Attend?
Healthcare professionals, startups and participants from Biotech, MedTech, especially manufacturers of drugs and devices will benefit from this webinar.
Also, anyone keen to learn more about regulatory processes in Europe is welcome.
What You Will Learn
Attendees will gain insights into:
- The regulatory structure in Europe, highlighting the recent updates
- The intricacies and complexities associated with CTIS
- Assessing whether these recent regulatory changes still position Europe as a leading choice for conducting clinical trials
Xtalks Partner
GCP-Service International
GCP-Service International is a full-service contract research organisation, providing clinical research services since 2004. We are dedicated to catalyzing global clinical trials by offering dependable solutions for pioneering medical advancements. With branch offices in Germany, Netherlands, Poland, and Czech Republic, as well as a founding member of the association of international CROs (AICROS; a closely cooperating network of like-minded CROs), we are able to conduct clinical trials locally and globally, in various therapeutic areas.
We specialize in comprehensive management solutions for a diverse range of medical devices and pharmaceutical trials, from pre-market research to post-market monitoring. Our mission is to make clinical trials accessible, by ensuring research and development efforts are seamlessly supported, facilitating the advancement of healthcare innovations on a global scale.
At GCP Service International, we pride ourselves on our unwavering dedication to quality and precision. Our experienced team of professionals collaborates closely with clients, providing expert guidance at every stage of the clinical trial journey. We understand the critical importance of expeditious and accurate results in the healthcare industry, and we are here to empower you to achieve your research goals with confidence.
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