China ICH Study Group Workshop on the ICH E11 Guideline, 26 April 2013 in Beijing, China

In November 2012, the ICH Global Cooperation Group endorsed a training request from the China Food and Drug Administration (CFDA) for a China ICH Study Group Workshop on ICH E11 Guideline “Clinical Investigation of Medicinal Products in Pediatric Population”.

The workshop took place in Beijing, China on April 26, 2013, focused on current research situation and challenge of pediatric clinical study, ethical consideration, clinical pharmacology principle to support pediatric medicine development, key elements consideration of pediatric clinical study, and new dosage form research of pediatric medicine. Presentations were provided by experts from the MHLW/PMDA, China, US Clinical Institutes and industry.

Workshop attendees included participants from the CFDA (and relevant affiliates), China provincial FDAs, clinical institutes, and industry.

 

At a Glance...

26 April 2013 Beijing, China