PRZOOM - /newswire/ -
Williamsburg, VA, United States, 2008/10/02 - Pharmaceutical companies face another hidden secret when struggling against a shrinking R&D pipeline and slow FDA approvals: data quality or lack thereof.
The little secret of drug development: record integrity can make or break you. Without data quality, you can expect nothing but delays from the FDA. That means wasted money, poor investment returns and increased executive liability. And that’s just one of the challenges facing the pharmaceutical industry’s shrinking pipeline.
Speakers from the U.S. Food and Drug Administration (FDA), Cerulean Associates and several other companies will look at the progress, challenges and opportunities facing the drug industry’s quest to speed drug development through Quality by Design. Mr. John Avellanet, Cerulean’s Managing Director, will speak on the challenges executives must overcome to ensure data integrity and regulatory approval.
Mr. Avellanet has won wide praise over the past year for his informative and entertaining presentations. Several attendees of last month’s Contract Pharmaceutical & Outsourcing Conference signed up for the two-day affair just to see Mr. Avellanet’s 45-minute presentation.
“I’d go out of my way to hear John speak on any subject just to enjoy his style of message delivery,” said Wayne Starnes, a CEO and recent conference attendee.
You can register for the webcast of this event at: PharmaQbD.com. Journalists needing an advanced copy of Mr. Avellanet’s presentation, or access to some of his other published work on speeding new drug development, may contact him directly.
John Avellanet is a leading expert, speaker and syndicated author on cost-effective compliance and quality systems. A former C-level executive for a Fortune 50 combination device and biotechnology subsidiary, he writes the monthly executive newsletter, SmarterCompliance™. In 2006, he co-founded his independent consulting firm, Cerulean Associates LLC.
Cerulean Associates LLC (ceruleanllc.com) is a small, private compliance consulting company that helps executives implement lean compliance, quality by design and effective management oversight, in part through its SmarterCompliance™ Toolkit executive coaching program.