The presentation will discuss the ethical and scientific considerations for enrolling children in clinical trials, as they are described in the recently published draft guidance, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

The history underpinning the pediatric ethics regulations will be included.

Topics such as scientific necessity, component analysis, and how to define risk and prospect of direct benefit in the context of a pediatric protocol will be discussed.  

MODERATOR:

Ken Kobayashi - President - Small Woods Biopharma Consulting LLC

SPEAKER:

Donna Snyder - Executive Physician - WCG