Moderator: Peggy Wright, Editor of Transdermal
Presenters: Gary L. Yingling and Karl M. Nobert, K&L Gates
Gary’s law practice focuses on regulatory and legal issues concerning food, drugs, medical devices, and cosmetics. He has represented clients before the FDA and other state and federal regulatory agencies. Previously, Mr. Yingling was president of the Food and Drug Law Institute for nine years and served for ten years in the FDA's office of the general counsel, first as a trial attorney and later as associate chief counsel for its Bureau of Veterinary Medicine and the deputy chief counsel for administration. Before attending law school, he practiced community pharmacy and is a registered pharmacist in Maryland and the District of Columbia.
Karl, an associate in the firm’s Washington office, advises clients on regulatory issues associated with the manufacture, sale, promotion, import and export, and distribution of food, Rx drug products, over-the-counter drugs, medical devices, dietary supplements, and animal feed. Previously, Mr. Nobert practiced with firms in both Washington, DC and New York.
CDs are non-returnable/non-refundable
Transdermal is the only technical publication devoted exclusively to readers involved in development and production of pharmaceuticals delivered through the skin.
Webinars
Industry Update: Issues and Trends Related to FDA’s Regulation and Approval of Transdermal and Related Drug Delivery Systems, 1/11
CD of live broadcast 1/18/11
Focusing on transdermal and related drug delivery systems, the presenters provide an overview of the FDA’s approval process for both branded and generic drugs, including a discussion of the Investigational New Drug (IND) and the New Drug Application (NDA) processes as they relate to the approval of transdermal patches and other dermal delivery drug products. The webinar also provides a summary of recent FDA regulatory and enforcement actions involving transdermal drug products.
Focusing on transdermal and related drug delivery systems, the presenters provide an overview of the FDA’s approval process for both branded and generic drugs, including a discussion of the Investigational New Drug (IND) and the New Drug Application (NDA) processes as they relate to the approval of transdermal patches and other dermal delivery drug products. The webinar also provides a summary of recent FDA regulatory and enforcement actions involving transdermal drug products.
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