Pediatric Research in the US: Are We There Yet?

Date(s) And Time(s):
Oct 12 2010 8:00AM - Oct 13 2010 5:00PM

Location:
Double Tree Hotel and Executive Meeting Center
8120 Wiesconsin Avenue
Bethesda, MD 20814

Interest Area(s):
Clinical Research, Clinical Safety/Pharmacovigilance, Outsourcing, Project Management, Regulatory Affairs, Research & Development

Overview:

Join Pediatric Research Experts to Share Solutions to the Challenges Involved in Constructing and Conducting Global Pediatric Programs.

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.

FEATURED TOPICS
• 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, efficient 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.

Target Audience:
WHO SHOULD ATTEND
•Academic Health Centers/Investigator sites
•Business strategy
• Chemistry, Manufacturing and Controls/Good Manufacturing Practices
•Clinical research and development/Clinical supplies
•Clinical safety and pharmacovigilance
•Good clinical practices
•Nonclinical laboratory safety assessment
•Outsourcing
•Project management
•Regulatory aff airs
•Statistics

Event Code:
10027

Contact Information:
Contact Constance Burnett. Program Developer, Phone +1.215.293.5800
Fax +1.215.442.6199, email Constance.Burnett@diahome.org