Washington, DC – Considerable progress has been made to advance pediatric drug research and to ensure appropriate drug product labeling for children but much still needs to be done for pediatric device research and development. On October 24, 2014, physician-scientists, pediatric surgeons, engineers, policy makers, and government officials will gather in the Knight Conference room at Washington, DC’s Newseum to discuss the critical issues pertinent to pediatric device development. Margaret Hamburg, MD, Commissioner of the U.S. Food and Drug Administration (FDA), will deliver the Opening Keynote address.
Thanks in large part to the passage of the Pediatric Medical Device Safety and Improvement Act (PMDSIA) in 2007 and its reauthorization in 2012, a series of innovations have been introduced including the establishment of non-profit consortia to stimulate pediatric device development. The Sheikh Zayed Institute for Pediatric Surgical Innovation, in partnership with University of Maryland Clark School of Engineering, leads one of the consortia.
“The FDA funded our consortium to facilitate the development, production, and distribution of pediatric medical devices. We have been doing just that, in part, by creating a network of pediatric stakeholders. Our annual symposium provides a forum for discussion on the pediatric device development process and establishing a culture of cooperation among all stakeholders,” notes Sheikh Zayed Institute Vice President, Peter Kim, MD, CM, PhD.
“We strongly believe that our symposium will provide a novel approach for the dissemination of information, discussion of ideas, informal didactic opportunities, and debate on critical issues that will provide a forum for open dialogue and cooperation among many diverse entities,” says Dr. Kim.
Children’s National Health System President and CEO, Kurt Newman, MD, hopes that “discussions during the symposium will result in tangible outcomes in the embodiment of policy documents and a formal report that represent the positions of all stakeholders in the field, as well as the potential to inform future policy and clinical practice.”
The objectives of the conference are:
- To identify concrete, achievable action items and assign them to relevant parties
- To establish a set of scientific, clinical, regulator, and policy recommendations required to advance the field
- To agree upon a select target publication, presentation, legislative, regulator, appropriate media strategy and targeted outreach campaign to forward conference objectives
The Best Pharmaceuticals for Children Act (BPCA) provides drug manufacturers with significant incentives to pursue pediatric drug research. Similar efforts have been made in the pediatric device arena. Namely, the 2007 Pediatric Medical Device Safety and Improvement Act (PMDSIA) has made great strides in narrowing the gap.
For more conference information, please visit the registration page.
Joe Cantlupe or Leah Parker at 202-476-4500.
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