Why PIE is Not the Norm and Why It Works | AMCP Nexus 2024
Charlie Dragovich, Senior Director and Client Strategist at Cencora, talks about the way regulations usually work and how the road to the Preapproval Information Exchange Act was different.
“Normally, when new types of regulations come from a bill passed by Congress, the relevant agency puts forth the rules and regulations,” Charlie Dragovich, Senior Director and Client Strategist at Cencora said. “This was done kind of in reverse. The guidelines, by default, became the regulations for the law that was passed.”
Dragovich authored a poster titled, ‘Optimizing the timing of pre-approval information exchange (PIE) engagement for oncology products, products for rare diseases, and cell and gene therapies (CGTs),’ which was presented this week at AMCP Nexus 2024, held at the MGM Grand in Las Vegas.
Cencora is a drug wholesale company that partners with pharmaceutical companies and healthcare providers to facilitate care.
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