Pediatric Development Plus Recent Laws
April 21, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Overview: The art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last 10 - 14 years because of the encouragement of regulatory agencies in Europe and United States. Due to recent governmental initiatives such as the Pediatric Investigational Plans (PIPs) in Europe and the Pediatric Research Equity Act (PREA) in the United States, pharmaceutical companies have been given clear pathways and incentives to develop drug indications and products for this important group of patients. In addition to discussing the new regulations, practical and effective development approaches and study designs will also be examined. Why should you attend: Prescribing information was generated only in adult subjects up until European and United States governments passed laws to support pharmaceutical companies by clearly giving specific information on what the regulatory office needs to approve a pediatric indication. Additionally, adult data was able to be used to bridge to the pediatric population primarily by pharmacokinetic analysis. Areas Covered in the Session: Understanding new and important laws Developing a pediatric plan Identify limitations of working in children and how to solve the problem Utilizing adult data efficiently by including differences between adult and pediatric patients Examine study designs and approaches successfully used for approval and Interpret study results Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1AS7dB8 support@compliance4all.com www.compliance4all.com