Cegedim Dendrite enlists FDA expert
Margaret “Peg” O'Rourke, who spent a 35-year career at the FDA until her retirement earlier this year, has been named senior regulatory consultant for Cegedim Dendrite.
For the past 20 years, O'Rourke was responsible for enforcing the Prescription Drug Marketing Act (PDMA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA).
“Essentially I'm going to be doing the same thing for Cegedim Dendrite that I was doing for FDA, in the sense that I will be trying to assist the pharmaceutical industry in meeting the FDA regulations and statutes,” O'Rourke told MM&M.
As part of Cegedim Dendrite O'Rourke will be responsible for third-party audits; sales force and home office training; mock FDA audits, general consultation and expert guidance regarding PDMA compliance issues.