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
For More Information: