We invite you to join our next free educational webinar titled “Safety Perspective of the New EU Clinical Trials Regulation”.
This webinar aims to summarize the new EU Clinical Trial Regulation (CTR) 536/2014 changes, focusing on the safety aspects. We will guide you through the key differences between Directive 2001/20/EC and CTR, the transitional period specifics, an overview of the safety reporting framework, and how best to manage some of the challenges this new regulation may bring.
Choose between one of 3 sessions available for this webinar on April 14th:
Session 1: 14 Apr, 6am EST / 11am BST / 12pm CEST
Session 2: 14 Apr, 10am EST / 3pm BST / 4pm CEST
Session 3: 14 Apr, 2pm EST / 7pm BST / 8pm CEST
Who Should Attend:
Sponsors of Clinical Trials
Pharma professionals interested in all CTR safety aspects
Overview of the legislative background
Transitional period arrangements
Safety reporting to NCAs and ECs
Directive vs. Regulation on key safety aspects
Newly introduced obligations
At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.
About our Expert Speaker:
Sara Vodanovic Associate Director of Regulatory Affairs, Intelligence and Analytics, PrimeVigilance
Sara is a pharmacovigilance regulatory intelligence expert with 8 years of experience in this area as well as experience in XEVMPD, EudraVigilance Registrations, and safety reporting. She and her team are responsible for developing and maintaining the corporate proprietary intelligence system, which now includes more than 150 countries. This system covers the safety reporting requirements associated with medicinal products in clinical trials, authorized for marketing or made available through special access programs.