An agenda for the Pediatric Clinical Investigator Training Workshop is provided below for the convenience of workshop attendees.
Hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA), the Pediatric Clinical Investigator Training Workshop is scheduled for Thursday, Feb. 28, 2019, from 8 a.m. to 5 p.m. in the Great Room (Building 31, Room 1503A) at the FDA.
Download a printer-friendly version of the agenda here.
| Time | Activity |
|---|---|
| 8:00-8:10 a.m. | Welcome and Introduction Susan McCune, MD |
| 8:10-8:20 a.m. | Keynote Speaker/Setting the Stage Bridgette Jones, MD American Academy of Pediatrics (AAP) |
| 8:20-8:40 a.m. | Label Enabling Clinical Trials William Smoyer, MD Nationwide Children's Hospital |
| 8:40-9:40 a.m. | Hot Topics Extrapolation and Innovative Trial Designs Yodit Belew, MD Division of Antiviral Products Food and Drug Administration Molecular Targets -- Oncology Greg Reaman, MD Office of Hematology and Oncology Products Food and Drug Administration Enrolling Pediatric Patients in Adult Trials Tara Altepeter, MD Division of Gastroenterology and Inborn Error Products Food and Drug Administration |
| 9:40-9:55 a.m. | Break |
| 9:55-12:05 p.m. | The Basics (New Investigators) Opening an IND Michael Cohen-Wolkowiez, MD Pediatric Trials Network FDA Perspective of Study Design and Plan, Dose Selection John Alexander, MD Division of Pediatric and Maternal Health Food and Drug Administration Ethical Considerations Melanie Bhatnagar, MD Food and Drug Administration Pediatric Formulations Julia Pinto, PhD Food and Drug Administration Non-clinical Data Requirements Karen Davis-Bruno, PhD Food and Drug Administration Good Clinical Practice and Understanding the Regulations Susan Leibenhaut, MD Food and Drug Administration Safety Considerations: Regulatory Definitions and Practical Considerations Ramy Abdelrahman, MD Food and Drug Administration Discussion/Case Presentation Michael Cohen-Wolkowiez, MD Pediatric Trials Network Jonathan Davis, MD Tufts Medical Center |
| 12:05-1:00 p.m. | Lunch |
| 1:00-2:00 p.m. | Pediatric Trial Funding and Engagement Panel Discussion
|
| 2:00-3:30 p.m. | Practical Applications with Case Studies Moderator: Lynne Yao, MD Table Moderators:
|
| 3:30-3:45 p.m. | Break |
| 3:45-4:30 p.m. | General Questions and Answers Full Panel with Dr. Lynne Yao (Moderator) |