Information About IRAUP.com
 
   
 
 
International Regulatory Affairs Focus: Pediatric Drug Development
African Clinical and Regulatory Scientists Speak on Pediatric Drugs Development .
29 November, 2007 by Solomon K. Sackitey

A renowned Nigerian Clinical and Regulatory Scientist, Jethro Ekuta , DVM, PhD, Group Director, Aggregate Safety Reporting in Global Pharmacovigilance and Epidemiology at pharmaceutical giant Bristol-Myers Squibb was one of several featured speakers at the 2007 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition at the San Diego Convention Center, San Diego, California which was held on 11-15 November, 2007.

At the same conference, another African, Henrietta Ukwu , M.D, a Senior Vice President of Worldwide Regulatory Affairs who is also a Professor, spoke on “Clinical and Regulatory Challenges in Pediatric Drug Development”.

Speaking on the topic “Regulatory Approaches for Extrapolating Data to the Pediatric Populations”, Dr. Ekuta directed attention to an apparent oversight involving the enrollment of children in clinical trials. Drug prescriptions for children, for the most part, have been based on estimates of adult drug dosage. This approach may be changing soon as Global Regulatory champions, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have made it a requirement now require that, drugs indicated for the pediatric population should have supporting clinical data from said population.

Dr. Ekuta was on a panel discussion which reviewed the current thinking of EU and US regulators with regards to Regulatory and Clinical Approaches, Challenges and the FDA’s experience in Pediatric Drug Development.

Additional coverage on pediatric drug development and regulation is available here .