Paediatric Drug Development - Adult Data and Relevant FDA Laws 2015 is a webinar that covers topics such as:
- Content of Pediatric Study Plans (PSP)
- Review BPCA and PREA laws and changes under FDASIA
- Compliance with PREA and BPCA
- FDA Review of PSP
- Important links to relevant areas on FDA website
Paediatric Drug Development - Adult Data and Relevant FDA Laws 2015 is intended for:
- Regulatory Specialists
- Project Managers
- Pharmacokineticists
- Clinical Scientists
- Product Development Scientists
- Statisticians
- Clinical Research Scientists
- Product Development Manages
- Writers who develop manuscripts for publication
- Clinical Research Associates
- Independent physicians who serve as investigators for the study