Overview: 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.
Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA - mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, especially generic and 505(b)(2). Due to shortcomings found during site inspections, lack of inspection resources and the general tightening of FDA safety reviews, FDA has started imposing some unwritten requirements for the acceptance of such data. This webinar explores these requirements and how you can ensure compliance.
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
