Cegedim Dendrite taps O'Rourke as consultant
Sales, marketing and compliance solutions consulting firm Cegedim Dendrite has hired one of the nation's foremost FDA regulations experts.
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.
PDMA amendments affect the distribution of prescription drug samples and the integrity of the national drug distribution system, including counterfeiting and the importation of prescription drugs into the US.
“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. “It's a little different side of the coin but not totally. The whole point is to help the pharmaceutical manufacturers comply with the FDA rules and regulations.”
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.