Pediatric Drug Development MasterClass - US edition

Participants will learn which trials in minors make sense, which ones are pointless, and which ones are even harmful. Good negotiations can save millions of euros and avoid potential EU damage lawsuits.
 

17-19 February, 2026, Virtual

STARTING TIME EST 08:00 A.M. | PST 05:00 A.M. | UTC 13:00

Overview

Pediatric Drug Development (PDD) is a controversial matter. Its basic ideas emerged when in the 1950s babies were treated with antibiotics and toxicities were observed. Now the new discipline of developmental pharmacology wanted more pediatric drug studies, emphasizing that children are not small adults. Since 1997 US law rewards pediatric drug studies with patent extension; since 2007 the EU demands pediatric investigation plans (PIPs). Without an approved PIP, EU approval is blocked. However, the children-are-therapeutic-orphans and children-are-not-small adults mantras are partially correct in babies, but not until the 18th birthday. Companies benefit from US patent extensions.

The EU demands studies early in drug development, the reward might come a decade later. Minors are not another species. They need assessment of doses and safety, not repeated proof of efficacy. It is an open secret in industry that many regulatory pediatric studies are questionable. Dr. Roses papers and textbooks offer a systematic analysis across all clinical areas. In negotiating with the FDA and the European Medicines Agency (EMA), companies can and should argue against exaggerated demands and the claim that these studies benefit child health. The authorities know that scientifically their demands are on shaky grounds. Companies should not be confrontational from the start. But: speak softly and carry a big stick. FDA & EMA will try to avoid controversial public discussions. Negotiating FDA initial study plans (iPSPs) and EMA PIPs has become a routine where regulatory pediatric assumptions are accepted. But companies should become more bold in pushing back. Participants will learn which trials in minors make sense, which ones are pointless, and which ones are even harmful. Good negotiations can save millions of US $ and can avoid potential US damage lawsuits.

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WHO SHOULD ATTEND

From life science industry:
-Regulatory affairs
-Clinical development
-Project management
-Communication
-Preclinical development
-Formulation development
-CMC
-Clinical pharmacology
-Safety
-Medical affairs

From academia:
-Students and postgraduates of medicine, pharmacology, life sciences and public health