Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC)

• Date:
  ponedeljek, 18 Maj 2015, All day
• Lokacija:
  European Medicines Agency, Amsterdam, the Netherlands

The International Neonatal Consortium is a coalition of industry, academia, patient representatives, the Food and Drug Administration, the European Medicines Agency, other governmental agencies, foundations, professional organizations, and the Critical Path Institute (C-Path) that will focus on accelerating the development of therapeutics for the neonatal population. At this workshop, participants will prioritise projects and initiate collaborations to develop safe and effective treatments for neonates. Registration open until 11 May 2015.

Documents

Agenda: International Neonatal Consortiu: Programme and agenda

Presentation - International Neonatal Consortium: Welcome

Presentation - The value of a Neonatal Consortium - A regulators perspective (Ralph Bax)

Presentation - The ABCs of regulatory science (Susan McCune)

Presentation - Moving neonatology into the modern era of drug development - Overview of potential consortium projects and deliverables (Mark Turner)

Presentation - The c-path vision: Sharing data and expertise to accelerate the development of safe and effective therapies for neonates (Martha Brumfield)

Presentation - Data for executing the consortium’s research plan: applying regulatory science to neonatal electronic data (Neena Modi)

Presentation - Moving away from traditional networks towards interactive dataset sharing (Dominique Haumont)

Presentation - Breakout session - Neonatal brain Injury (Heike Rabe and Ronit Pressler)

Presentation - Breakout session - Neonatal lung injury (Robin Steinhorn and Mary Short)

Presentation - Breakout session - Neonatal gastrointestinal injury (Kate Costeloe)

Presentation - Breakout session - Neonatal sepsis (Danny Benjamin and Catherine Sherwin)

Presentation - Breakout session - Neonatal abstinence syndrome (John Van Den Anker)

Presentation - Breakout session - Retinopathy of prematurity (Boubou Hallberg)

Multimedia