Pediatric Drug Development – Relevant FDA Laws and Changing Approach

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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:

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

Bob Kunka

Bob 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 three companies. Prior to this, he was Assistant Professor at the University of Pittsburgh where he taught undergraduate and graduate courses in pharmacokinetics. He earned his Ph.D. in pharmacokinetics at the University of North Carolina at Chapel Hill and has a B.S. in pharmacy at the University of Illinois at the Medical Center.

Bob has been consulting (The Kunka Group, Inc.) since 2008 and will be presenting at the 2014 World Congress of Basic and Clinical Pharmacology meeting in Cape Town, South Africa on July 17 as a member of a program entitled The Changing Face of Pediatric Drug Development. The title of his talk is Pediatric Drug Development from the Sponsor’s Perspective and Bridging to Relevant Data.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance