2015 - Webinar On Pediatric Drug Development ? Relevant FDA Laws and Changing Approach

Understanding the FDA approach to pharmaceutical and clinical development in pediatric patients will allow those responsible for planning and implementation of the company to plan effectively. This webinar will benefit formulation development, preclinical, clinical, and regulatory scientists in pharmaceutical companies and clinical research organizations (CRO) that are developing an indication for pediatric patients.
Areas Covered in the Session :
Review BPCA and PREA laws and changes under FDASIA
Content of Pediatric Study Plans (PSP)
FDA Review of PSP
Compliance with PREA and BPCA
Important links to relevant areas on FDA website
Who Will Benefit:
Project Managers
Regulatory Specialists
Clinical Scientists
Pharmacokineticists
Statisticians
Product Development Scientists
Product Development Manages
Clinical Research Scientists
Clinical Research Associates
Writers who develop manuscripts for publication
Independent physicians who serve as investigators for the study