Interview with Vijay Govindarajan
Posted: 20 October 2010
RAPS had a chance to speak with Vijay Govindarajan, the Earl C. Daum 1924 professor of international business and the founding director of the Center for Global Leadership at the Tuck School of Business at Dartmouth College about how regulation and constraints in healthcare can drive innovation and what healthcare product companies can learn about innovation from countries like India. Govindarajan is widely regarded as one of the world's leading experts on strategy and innovation and co-author of The Other Side of Innovation: Solving the Execution Challenge. He was the opening keynote speaker at the 2010 RAPS Annual Conference & Exhibition in San Jose, CA.
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Interview with Ray Huml
Posted: 3 June 2010
With regulatory professionals being called upon to play critical roles on due diligence teams, the Regulatory Affairs Professionals Society (RAPS) recently published Introduction to the Due Diligence Process, by Raymond A. Huml, MS, DVM, RAC, executive director of global due diligence in corporate development, Quintiles Inc., as a helpful primer on the subject for regulatory professionals and pharmaceutical executives involved in the due diligence process. RAPS spoke with Huml about the book, and about what due diligence is and what it means to regulatory professionals.
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Defining Drugs, Devices & Combo Products
Posted: 12 December 2009
With the US Food and Drug Administration (FDA) proposing new rules intended to clear up confusion regarding requirements for combination products, such products have become a hot topic in regulatory circles. Just prior to FDA's proposal, during the RAPS Annual Conference, RAPS board member and vice president at GE Healthcare, Mark D. Kramer, MS, RAC, sat down to discuss the differences between drugs and devices and what constitutes a combination product with Suzanne O'Shea, JD, counsel, Baker and Daniels LLP. O'Shea served as regulatory counsel at FDA for 21 years, including, most recently as product classification officer in FDA's Office of Combination Products.
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