Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling and documentation requirements will also be reviewed and explored.
Why You Should Attend:
Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
- FDA Regulations and Guidance Documents for Phase I clinical trials
- Key Elements and Best Practices of GMP for Phase I clinical trials
- IND content and format for CMC information
- Vendor Selection and Management for outsourcing early manufacturing
- Raw Material selections and considerations
- Regulatory Affairs Departments
- Quality Departments
- Research and Development Departments
- Manufacturing Departments
- Clinical Operations Professionals