Cegedim Dendrite enlists FDA expert

Share this article:
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 (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.

Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Antidote: On Cystic Fibrosis treatments

Antidote: On Cystic Fibrosis treatments

Recent treatments in CF, including the inhaled antibiotic Tobramycin, have increased lifespan well into adulthood.

The $3 generic and the $1,000 pill: pharma outsiders just don't get it

The $3 generic and the $1,000 pill: pharma ...

What do you call the people who treat medical breakthroughs as if they were bank heists? Malicious? Uninformed? Not with it?

Leadership Exchange Uncut : The Agency-Client Relationship

Leadership Exchange Uncut : The Agency-Client Relationship

Click the above link to access MM&M's first Leadership Exchange Uncut e-book, "The Agency-Client Relationship"