Pediatric Research in the US: Are We There Yet?

Venue: Double Tree Hotel and Executive Meeting Center

Location: Bethesda, Maryland, United States

Event Date/Time: Nov 08, 2010 End Date/Time: Nov 09, 2010
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Over the past three years industry has been busily climbing the steep learning curve of the EU Pediatric Legislation. With approved products and late stage development programs under compliance with the PIP, we have moved into a new era where early development projects are, for the fi rst time, receiving input from the EU. How can the US FDA and industry dance with two partners and not step on anyone’s toes.

This workshop will review the global regulatory environment of pediatric research, share case studies for the successful implementation of clinical, nonclinical,and formulations development, and discuss the future of US pediatric research in the 2012 debate.

• Regulatory Challenges in an Evolving Global Environment
This session will look at how US and EU policies align (or not) to encourage
pediatric research as we move forward.
• Global Pediatric Strategy: Reality or Fantasy
This session will look at what we have learned in these last three years
and the challenges we continue to face.
• Implementation Challenges of Pediatric Research: You Want Me to Do What?
This session will address recurrent challenges that pediatric study teams
face in areas such as appropriate preclinical studies, child-friendly formulations,
effi cient methods in pharmacokinetic sampling, study designs
in rare pediatric populations, and ethical considerations. We will look at
these recurrent challenges and specifi c remedies utilized by study teams
to overcome these challenges and deliver high quality, informative data.
• Path Forward
This session will look at what we have learned, particularly for the
issues discussed in this workshop, and focus on what still needs to be
solved to improve the path towards better medicines for children.

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