How to Use Foreign Trial Data in Your NDA Approval Process
17 Nov 2010
Webinar
In this NDA Approval Process training Webinar learn the guidance and regulations governing FDA s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.
Areas Covered in the Seminar:
Guidances and regulations that govern the FDA s acceptance of foreign trial data as pivotal data for NDA approval.
What you can do to ensure compliance.
Design considerations and requirements for foreign trials.
Identify which guidances and regulations govern the FDA s acceptance of foreign trial data as pivotal data for NDA approval;.
Discuss how FDA is implementing these rules and what you can do to assure compliance; and
Recognize design considerations and requirements for foreign trials.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including:
Managers in Clinical Development and Project Leaders
Quality Assurance Managers and auditors
Clinical Research Associates
Clinical Operations Staff
Regulatory Compliance Associates and Managers
Clinical Safety Staff
Past Events
How to Use Foreign Trial Data in Your NDA Approval Process - 17 Nov 2010, Webinar (8651)
How to Use Foreign Trial Data in Your NDA Approval Process 2026
Important
Please, check "How to Use Foreign Trial Data in Your NDA Approval Process" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Medical device, Medical laboratories, Pharma
