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Second Annual Neonatal Scientific Workshop, March 7-8, 2016, FDA White Oak Campus, Silver Spring, Maryland

Goals and Objectives

The Food and Drug Administration (FDA) is announcing a public workshop co-sponsored by the Agency and the Critical Path Institute (C-Path) to discuss on-going efforts by the International Neonatal Consortium (INC) to apply regulatory science to neonates.

The purpose of this scientific workshop is to continue discussion among regulators, researchers, health care providers, representatives of the pharmaceutical industry, health care organizations, parent/patient advocacy organizations, and the general public regarding the regulatory science required to accelerate the development of therapeutics for the neonatal population. The workshop will seek to 1) assess the progress of INC 2) engage additional participants in the current INC projects, and 3) explore additional initiatives that the INC members may decide to undertake.

Who should attend

The primary audience for the workshop includes regulators (both in the U.S. and abroad), researchers, health care providers, and representatives of the pharmaceutical industry, health care organizations, parent/patient advocacy organizations, and the general public. The Workshop will seek input from all attendees.

Registration

Individuals who wish to participate in the scientific workshop (in person or via the Internet) may register on or before Feb. 25, 2016, by visiting: Second Annual Neonatal Scientific Workshop (http://www.cvent.com/d/4fq9yg). Early registration is recommended because limited seating is available. Registration is free and will be on a first-come, first-served basis. Onsite registration on the day of the scientific workshop will be based on space availability. 

If you need special accommodations because of disability, please contact Project Coordinator Alicia West, (520) 547-3457, email: awest@c-path.org, at least 7 days before the scientific workshop.

For questions regarding registration, please contact Project Coordinator Alicia West, (520) 547-3457, email: awest@c-path.org, at the Critical Path Institute, (520) 547-3440.

A live webcast of this scientific workshop will be viewable at the Adobe Connect Link: https://collaboration.fda.gov/neonatal0316/ on the day of the scientific workshop.

Additional questions? Contact

Jacqueline Brooks-Leighton, The Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Building 21, Room 4521, Silver Spring, MD 20903, (301) 796-4442; Jacqueline.brooks-leighton@fda.hhs.gov.

Agenda (PDF 392 KB)

Final Slide Presentations (PDF 9.88 MB)

Links to the Webcasts:

March 7th Links:

Part 1: https://collaboration.fda.gov/p9t20hy19m9/

Part 2:https://collaboration.fda.gov/p1pbrinb7he/

Part 3: https://collaboration.fda.gov/p87zi4b0y39/

March 8th Links:

Part 1: https://collaboration.fda.gov/p30tq9qg0v3/

Part 2: https://collaboration.fda.gov/p5o6f5x4931/

Part 3: https://collaboration.fda.gov/p99wx8re39n/

Part 4: https://collaboration.fda.gov/p67bif713ly/

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