|
The Drug Development Process:
Getting from “Hit” to “Lead”
- Overview of the Drug Development
Decision Making Process
- Go Criteria at Major Mistakes
- Lead Identification
- The IND/CTX: First In Man, Proof of Principle
Patent Strategies and Marketing Exclusivity
- Understanding Patent Definitions
- Patent Extensions
- Filing Strategies
- Market Exclusivity
|
Understanding US
FDA Regulations: FDA's
approach to CTD
- FDA Organization and Role
- US Regulations
- Drug Development
- INDs
a. General
b. Review Process
c. Maintenance
d. Actions
- INDs - Specific Considerations -
- INDs - Specific Considerations - Preclinical
- INDs - Specific Considerations - Clinical
- New Requirements
a. Pediatric Rule
b. Pediatric Exclusivity
c. Financial Disclosure
- Accelerated Development Options
- Interactions width FDA
- Organization and Content of NDA's
- FDA Review of NDA's and BLA's
- Other Topics of Interest: The Clinical
Trials Database Patents and Exclusivity
- Successfully Maintaining NDA's: SUPAC
IR, MR, SS
- Regulatory Intelligence
|
