The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now showing up in CTIS. Nevertheless, planning ahead for a successful submission and knowing what to expect from the new system can be a challenge.
In this session, our experts answered questions related to the changes made and points to be noted, such as:
- Are you wondering when you should transition your ongoing trial to the EU CTR?
- Whether you can switch from the trial-centric approach to the organization-centric approach?
- How and to whom to submit your safety reports under the EU CTR?
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Featured Speakers
Ruxandra Popescu
Senior Regulatory Scientist, Certified EMA CTIS Sponsor Master Trainer
Ruxandra is a certified EMA CTIS Sponsor Master Trainer, qualified to disseminate the knowledge on the submission of clinical trials in EEA under the Reg. (EU) no. 536/2014. She ensures clients’ readiness for EU-CTR implementation and provides regulatory oversight of the clinical trial process particularly the submission strategy for multinational studies.
Lucy Palatin
Senior Regulatory Scientist, Vigilance Operations
Lucy has 10+ years of experience in setting up and managing clinical safety and pharmacovigilance systems. This includes the preparation of Safety Management Plans (SMPs), the management of Individual Case Safety Reports (ICSRs), EudraVigilance registration (company and product), etc.
