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Former High-Ranking FDA Official Joins Cegedim Dendrite.


Peg O'Rourke Will Bolster Pharmaceutical Industry's Leading Regulatory Compliance Business

BEDMINSTER, N.J. -- Cegedim Dendrite dendrite: see nervous system; synapse. , the world's leading provider of sales, marketing and compliance solutions to the pharmaceutical industry, has hired one of the nation's foremost experts in complying with U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) regulations.

Margaret "Peg" O'Rourke, who spent her entire career at the FDA until her retirement earlier this year, will be a senior regulatory consultant for Cegedim Dendrite, effective immediately.

For the last 20 years, O'Rourke was responsible for enforcing the Prescription Drug Marketing Act
This article refers to a federal law. For other meanings, see PDMA.
The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.
 (PDMA PDMA Product Development & Management Association
PDMA Prescription Drug Marketing Act
PDMA Philadelphia Direct Marketing Association
PDMA Plastic Deformation Magnetic Assembly
PDMA Polarisation Division Multiple Access
) amendments to the Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.  (FDCA FDCA Food, Drug and Cosmetic Act
FdCA Federazione dei Comunisti Anarchici (Federation of Anarchist Communists, an Italian political organization)
FDCA Field Data Collection Automation (US Census) 
). PDMA amendments affect the distribution of prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug,  samples and the integrity of the national drug distribution system, including counterfeiting and the importation of prescription drugs into the U.S.

"We're pleased that Peg is joining us," says Bill Buzzeo, vice president and general manager, Cegedim Dendrite Compliance Solutions, powered by Buzzeo PDMA. "During her 35 years at the FDA, she led several regulatory efforts that continue to have a major impact on the pharmaceutical industry. Her insight and expertise will be invaluable to companies as they strive to meet FDA regulatory requirements, particularly in light of the recent implementation of the PDMA inspection program."

O'Rourke is the latest addition to Cegedim Dendrite's PDMA Consulting Team, which includes many former government and industry compliance leaders. As part of the team, O'Rourke will be responsible for third-party audits; sales force and home office training; mock FDA audits; and general consultation and expert guidance regarding PDMA compliance issues.

About Cegedim Dendrite:

Cegedim Dendrite provides the pharmaceutical companies around the world with vital support for successful Customer Relationship Management (CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization. ) activities. With nearly 200,000 sales representatives using its products worldwide, Cegedim Dendrite is the world's leading CRM provider for the life sciences industry. This business unit, created in May 2007 when the France-based CEGEDIM S.A. Group acquired Dendrite International, also provides sales, marketing and regulatory compliance solutions in more than 80 countries. To learn more, please see our website: www.cegedimdendrite.com.

About CEGEDIM:

CEGEDIM has developed exclusive databases and high value-added software solutions since 1969. Established as the world's leading CRM provider for the life sciences industry with its Cegedim Dendrite Business Unit, CEGEDIM provides the world's largest pharmaceutical companies with vital support for successful CRM (Customer Relationship Management).

CEGEDIM Strategic Data and CEGEDIM Customer Information business units are also dedicated to pharmaceutical companies and help them measure sales & marketing effectiveness thanks to the Group's strategic databases focused on the world drug market. These two business areas fall into the "Healthcare and strategic data" division of the CEGEDIM Group, which comprises the above services specifically designed for pharmaceutical companies, together with specific solutions dedicated to healthcare professionals (notably physicians and pharmacists in Europe) and health insurance providers. The "Technologies and services" division, mainly French oriented, capitalizes on the above skills to provide specific complementary solutions to clients of various sectors.

CEGEDIM generated turnover of EU541 million in 2006. Including Dendrite, the combined Group generates EU877 million revenue on a 2006 full year basis with a workforce of 7,500 and operations over more than 75 countries. To learn more, please see our website: www.cegedim.com.

Listed on Eurolist by Euronext Paris, compartment B - ISIN Isin (ĭs`ĭn), capital of an ancient Semitic kingdom of N Babylonia. The city became important after the third dynasty of Ur fell to the Elamites and the Amorites (c.2025 B.C.). The phase from c.2025–c.1763 B.C.  FR0000053506 - Reuters CGDM CGDM Consortium on Green Design and Manufacturing .PA - Bloomberg CGM (1) (Computer Graphics Metafile) An ISO/IEC standard format for 2D graphics images introduced in 1987. Primarily a vector graphics format for technical illustrations and geophysical visualizations, CGM also supports raster graphics and text.  
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Publication:Business Wire
Date:Oct 22, 2007
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