Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Washington Marriott Hotel

Apr 15, 2013 8:30 AM - Apr 17, 2013 12:00 PM

1221 22nd Street NW, , Washington, DC 20037-1294 , USA

CMC Workshop: From Drug Development to Global Supply to Patients

Back to Agenda

Session 7A: Pediatrics: Challenges and Specific Requirements

Session Chair(s)

Jenny Walsh, PhD

Director

Jenny Walsh Consulting Ltd., United Kingdom

The development of paediatric medicines can be particularly challenging, since it is necessary to consider the diversity of this patient population in terms of physiological and biological maturation, compliance challenges such as acceptable palatability and potential safety concerns associated with the required excipients. This session will discuss some of these challenges in more detail and provide an overview of the European perspective including Paediatric Investigation Plans (PIPs). An update on the joint AAPS/Pediatric Task Force Points to Consider Document will also be provided.

Speaker(s)

Challenges Associated with Developing Medicines for Children - An Industry Perspective

Gossett Campbell

GlaxoSmithKline, United States

Sr. Scientific Investigator, CMC Technical Leader Global Formulation Development

EU Paediatric Investigation Plans

Mike H Saleh, MS

Pfizer, Inc., United States

Director, Global Chemistry, Manufacturing and Controls

AAPS/Pediatric Task Force Points to Consider Paper on Pediatric Formulations Development

Georgia Charkoftaki, PhD

National and Kapodistrian University of Athens, Greece

Research Associate Laboratory of Biopharmaceutics and Pharmacokinetics

Have an account?