On Tuesday, March 15, 2016, our President and CEO Fran Zipp and Senior Associate Terri Nataline presented in a forum entitled “GDUFA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes” at DCAT Week. DCAT Week is the premier business development event for companies engaged in pharmaceutical development and manufacturing and related industries. It is organized and hosted by the Drug, Chemical & Associated Technologies Association (DCAT) to assist its member companies with their business development objectives.
Fran presented a session focusing on understanding the most important US and EU regulatory initiatives affecting manufacturing and supply chains, from raw materials to APIs, analyzing the impact on pharmaceutical customer and supplier expectations, while Terri presented on reauthorization of GDUFA II. The forum included not only Fran and Terri, but a representative from FDA as well, Dilcia Granville, who presented on API inspection trends, and Robin Kumoluyi, VP and Global Head, Third Party Operations, Novartis.