Since 1997 the US reward pediatric drug studies with patent extension; since 2007 the EU demands pediatric investigation plans (PIPs) for new drugs. Without PIP, the EU approval of new drugs is blocked. Participants in this Pediatric Drug Development online masterclass will learn which trials in minors make sense, and which ones are pointless and even harmful. This can save companies millions of US $. Furthermore, they can avoid potential US damage lawsuits. #webinar
Key learnings:
Dose Assessment
Pediatric Legislation
Questionable Studies
Damage Lawsuits
Pediatric Careers
Negotiating
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