August 9th, 2017-Generic Products: Opportunities for Southern California Companies
Generic Products: Opportunities for Southern California Companies
"Generics - An Overview"
Giff Marzoni, Vice-President Global Pharmaceutical Development DavosPharma
"Navigating the Regulatory Paths for Generics"
Luman Wing, Director Executive Consultant, Cardinal Health
"Value Creation through Formulation of Generic Topicals"
John M Newsam, CEO Tioga Research
8 in 10 of the 4.5 billion US prescriptions in 2016 were for generic drugs. A generic drug is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. A generic drug is required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product, but need not contain the same inactive ingredients. It must, however, be proven to be bioequivalent to the brand name product.
If you are curious about the business drivers behind the generics industry, about the developmental and regulatory paths for a generic, about how bioequivalence can be proven, or about the strength of protection that a patent on an innovator product can provide, you might consider joining this event.
The event provides an introduction to the generics business in the US, overviewing business, technical, developmental and commercial aspects. Regulatory issues and requirements are summarized and strategies for realizing streamlined approvals outlined. And the event includes examples of where formulation creativity can establish a basis for a generic approval.