Robert L. Kunka, Ph. D. speaker of compliance global

July, 2015

Speaker: Robert L. Kunka, Ph. D.
Duration: 60 Minutes
Product ID: 700124


Paediatric Drug Development - Adult Data and Relevant FDA Laws.

Up until a few years ago FDA required pharmaceutical companies to duplicate the same studies that were required in adults in children. This requirement often prevented development in children because of time, money, and difficulty in running these studies in children.

In 2002 and 2003 Congress enacted laws that allowed pharmaceutical companies to utilize existing adult data to support a pediatric program. During the following two years 70 drugs for adults received approval for a pediatric indication. In 2012 Congress followed up with a law that applied what had been learned following 2003.

This webinar will review the two laws passed in 2002 and 2003: 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. Also, pediatricians who want to be investigators in pediatric clinical studies sponsored by pharmaceutical companies will give them a better idea of what a company wants done before the meet with the company.

read more