Overview:
Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy
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.
Who Will Benefit:
- Directors
- Managers
- Supervisors in Regulatory Affairs
- Manufacturing
- Quality Assurance
- Clinical Operations