Coordinated by FDA’s Office of Pediatric Therapeutics in collaboration with the Office of Counterterrorism and Emerging Threats (OCET), the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH).

There is a critical need for research to ensure that medical countermeasures (MCMs) are safe and effective for use in pediatric populations. The challenges associated with developing and evaluating drugs, biologics, and devices for children in the MCM context are complex. Addressing such challenges requires an enhanced understanding of the issues among scientists, policymakers, and the general public. This workshop, which is supported by FDA’s Medical Countermeasures Initiative (MCMi), aims to enhance FDA’s ability to foster the development of pediatric MCMs to respond to chemical, biological, radiological, and nuclear (CBRN) threats and naturally emerging infectious diseases, such as pandemic influenza. Through stimulating plenary and breakout sessions, this workshop will provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA and other stakeholders in the area of pediatric MCMs and public health preparedness.

Plenary Sessions and Breakouts
The workshop will feature plenary talks delivered by RADM Boris Lushniak, MD, MPH, Deputy Surgeon General (RADM, USPHS), US Department of Health and Human Services, Michael Selgelid, PhD, Senior Lecturer and Deputy Director, Centre for Human Bioethics, Monash University, and Jonathan Kimmelman, PhD, Associate Professor, Biomedical Ethics Unit, McGill University. It will also feature a number of breakout sessions, organized into concurrent Ethics/Policy and Science tracks.

Topics in the Ethics/Policy track will include: clarifying distinctions between INDs and EUAs, IRB review of MCM-related protocols, and examining “sound ethical reasons” for conducting certain kinds of pediatric MCM research.

Topics in the Science track will include: examining what types of data will support use of products as pediatric MCMs, risk communication and risk perception, human factors and pediatric MCM devices, and leveraging novel technologies to develop pediatric MCMs.

Who Should Attend?
Academics, regulators, public health professionals, industry, advocacy group representatives and members of the general public are invited to attend.

For more information, please visit the Official Event Website.