The area of pediatric development is relatively new and changing following the new laws. The use of adult data to support the pediatric initiative allows good adult information to support the children. This webinar will give you a good taste on what has happened recently.
We will discuss the two laws passed : Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) and review what pharmaceutical companies did in response to these laws. The FDA Safety and Innovation Act of 2012 (FDASIA) will also be described and how it changed the development process.
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 to be Covered:
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:
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