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
