Excipient Equivalence:

Implications for Customers and Suppliers
in a Changing Industry Landscape
with Case Study


Tuesday, March 16, 2010
1:15 - 2:45 pm, Empire Room
Waldorf-Astoria Hotel, NYC

Member: $59; Non-Member: $219


Program Description:

As an excipient is often utilized in multiple drug products, disruption of its supply can have an enormous impact on a pharmaceutical manufacturer and its customers. Increased global sourcing and the recent supply chain events have made the change of suppliers or the addition of a back-up supplier a critical issue. This session will provide a brief overview of how the pharmaceutical industry, the FDA, and IPEC (International Pharmaceutical Excipients Council) are addressing this highly controversial and pertinent matter. In addition, a case study will be presented on how Colorcon was able to capitalize on detailed interchangeability studies they had performed that allowed them to minimize the supply impact of the recent HPMC (hydroxypropyl methylcellulose) shortage.

Speakers:

Janeen Skutnik, Director/Team Leader of Quality & Regulatory Policy,
Pfizer Inc.

David R. Schoneker, Director of Global Regulatory Affairs,
Colorcon