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About This Webinar
This webinar aims to summarize the new Clinical Trial Regulation (CTR) EU 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.
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
- Q&A Session
Language:
English
Who can attend? Anyone with the event link can attend
Featured Presenters
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.
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic, and biotechnology companies. Our founders and leaders have an unrivaled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.
Founder & Managing Director
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