NEWS – New EU Clinical Trials Regulation Webinar

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

Agenda:

• 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.

 

Download PrimeVigilance Flyer “Are You Ready for EU Clinical Trials Regulation 536/2014 (CTR)?”

 

If you have any questions about our webinar please feel free to contact us.