Inside Industry Regulation: What to Expect and Why
Posted May 08, 2007
Research and development (R&D) jobs at pharmaceutical companies require a mindset that differs from that of the academic laboratory. That's because industry workers must at every step comply with strict regulations set forth by the U.S. Food & Drug Administration (FDA) and other federal agencies, plus their company's procedures.
To open a window into that highly regulated corporate world, Patty Bowers, regulatory compliance training manager for research and development quality assurance at Boehringer Ingelheim Pharmaceuticals, reviewed the history of FDA rules, the march of steps necessary to get a drug from R&D to market, and what companies expect of industry personnel to ensure compliance with this process. Held at Columbia University Hammer Health Science Center on January 11, 2007, the evening event was sponsored by the Science Alliance for Students and Postdocs.
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Science Alliance for Graduate Students and Postdocs
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Boehringer Ingelheim Pharmaceuticals
Patty Bowers has an MBA in human resources management and a BA in social sciences/justice & law administration. She is employed by Boehringer Ingelheim Pharmaceuticals, Inc., in Ridgefield, CT, where she has been the regulatory compliance training manager for research and development quality assurance for the past eight years.
Leslie Knowlton is a freelance writer based in New York City and on Deer Isle, Maine. With a master's degree in psychology, she spent more than a decade as a correspondent for the Los Angeles Times and a medical writer and contributing editor for the Psychiatric Times. Her work has also appeared in dozens of other newspapers and magazines including the Boston Globe, Chicago Tribune, New York Daily News, Cosmopolitan and Fitness.