The 2-day In-person Seminar: Preparing IND Submissions for Conventional and Orphan Products 2012 covers topics such as:
- Overview of FDA’s IND requirements
- Orphan Drugs and other Special
- Logistics of IND Submission: Best Practices for timely good quality IND application
- The Content and Format of an IND
- Lecture 6: Presenting Pre-clinical and Clinical Information in the IND
- CMC Section of an IND
- Best Practices for Maintaining an IND with the FDA
- FDA Meetings and Other Regulatory Interactions
The 2-day In-person Seminar: Preparing IND Submissions for Conventional and Orphan Products 2012 brings together:
- Orphan drug developers
- Sponsors of INDs
- Project management personnel
- Supervisors, and lead workers in Regulatory Affairs
- Manufacturing managers, supervisors & personnel
- Senior management executives (CEO, COO, CFO, etc)
- People investing in FDA-regulated product development projects
- Clinical and preclinical laboratory managers
