Topics
- Review of relevant FDA regulation, guidelines and points to consider for manufacturing and drug product composition
- Introduction into nanotechnology drug delivery and needs for improvement
- Clinical development planning and path to approvals
- Clinical research to support clinical development and protocol preparation for human study working with the FDA
Who should Attend
Regulatory Affairs Managers, Directors and VPs, Formulation Scientists and Researchers, Manufacturing Managers, Directors and VPs, Quality Managers, Directors and VPs, Strategic Planning Managers, Directors and VPs.