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 this Webinar
• 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
Robert L. Kunka, Ph. D. is an accomplished and respected scientist who contributed to the development of 28 approved pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submissions with successful clinical strategies, sound matrix management of individual study teams, and effective interactions with regulatory agencies leading to successful IND, aNDA, and NDA approvals. Bob's experience in drug development stems from 24 years in the pharmaceutical industry at GlaxoSmithKline (GSK), Chugai-Upjohn, and GD Searle.
Prior to this, he was Assistant Professor at the University of Pittsburgh School of Pharmacy where he taught graduate and undergraduate courses in pharmacokinetics. Bob earned his Ph.D. in Pharmacokinetics at the University of North Carolina (UNC) at Chapel Hill and Bachelor of Science in pharmacy at the University of Illinois at the Medical Center in Chicago. While at UNC, he was honored to be named the American Foundation for Pharmaceutical Education Charles J Lynn and Syndor Barksdale Penick Memorial Fellow. Bob has been consulting (The Kunka Group, Inc.) since 2008.View all trainings by this speaker