GMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products is a webinar that covers topics such as:
- Historical FDA cGMP requirements for drugs and biologics
- Key aspects of FDA cGMP requirements for IND products
- Regulatory guidelines; FDA, ICH, CHMP, EMEA
- Practical implications
GMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products brings together:
- R&D investigators
- Executive management
- Pre-clinical and clinical
- Product development
- QA/ QC
- Regulatory affairs
- Consultants
- Marketing
- Training