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.
Why Should You Attend:
This webinar will benefit Ph.D., M.D., Master’s, and B.S. scientists who are or will be in the following jobs on a pediatric development project:
• Project Managers;
• Regulatory Specialists who prepare the regulatory documents;
• Scientists who develop the needed clinical studies, e.g. clinical scientists, pharmacokineticists, statisticians;
• Product Development Scientists and Managers who develop the pediatric formulations;
• Clinical Research Scientists and Associates who monitor the studies;
• Writers who develop manuscripts for publication;
• Physicians who provide medical expertise to the study; and
• Independent physicians who serve as investigators for the study.
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
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.
Who Will Benefit:
• Project Managers
• Regulatory Specialists
• Clinical Scientists
• 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
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