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Drug Safety Alliance Quality and Regulatory Affairs Leader Earns International Certification

01-14-2009 01:31 PM CET | Health & Medicine

Press release from: Drug Safety Alliance

/ PR Agency: Menzies Consulting, Inc.
Regulatory Affairs Professionals Society Awards Canadian RAC Distinction to Joe Knight-McKenna

(Research Triangle Park, N.C.) Drug Safety Alliance (DSA), a global leader in pharmaceutical safety and pharmacovigilance, is proud to announce that Senior Director, Quality and Regulatory Affairs, Joe Knight-McKenna has earned the Regulatory Affairs Certification, Canadian RAC (CAN) distinction.

The certification was awarded to Knight-McKenna (MBA, CQM/OE, CQA, CSQE, RAC/CAN) by the Regulatory Affairs Professionals Society (RAPS) and its Regulatory Affairs Certification Board in late 2008. Knight-McKenna works at Drug Safety Alliance to ensure that regulatory reporting requirements are met for all clients to governing agencies all over the globe and that the quality of this data is very high.

“Regulatory compliance and quality control are essential considerations in today’s pharmaceutical industry worldwide. They require constant diligence and training to keep up with changes to avoid fines and other assorted disruptions to drug development,” said Cathy Stokes, president and CEO of Drug Safety Alliance. She added that industry leaders like Knight-McKenna who pursue continuing education in areas such as regulatory affairs make the industry stronger by sharing their knowledge with clients and peers.

Knight-McKenna, who presented on quality assurance protocols in Europe at this past Fall’s RAPS conference in Boston, earned this new certification by performing well on a comprehensive examination on Canadian regulations, laws, guidelines, and policies dealing with medical devices, biologics and drugs. Pursuit of the RAPS certification is voluntary. , The certification program, which was implemented in 1990 by RAPS, is designed to elevate professional standards, distinguish individuals demonstrating knowledge essential to regulatory affairs, and enhance individual performance.

“As more companies are utilizing Canada for performing clinical trials as well as marketing their products, it is important for DSA to demonstrate to our clients that we have a profound knowledge of the Canadian regulatory environment,” Knight-McKenna said, adding, “Understanding the Canadian regulatory environment, along with the US and EU’s, enables us to offer comprehensive global pharmacovigilance services.”

Knight-McKenna is responsible for Drug Safety Alliance’s quality management system, regulatory compliance and inspection readiness programs. In addition to his recent Canadian certification, Knight-McKenna has been RAC-certified for the United States since 1999 and for the European Union (EU) since 2003.

About Drug Safety Alliance
Founded in 2000, Drug Safety Alliance (DSA) provides pharmacovigilance expertise to large and small pharmaceutical and biotechnology companies to help them develop safe drugs and improve patient safety. DSA's mission is to partner with clients to mitigate their drug safety risks and to maximize product longevity and value. Driven by the highest ethical standards, DSA is uniquely focused to provide high-quality pre- and post-market drug safety services including domestic and international regulatory compliance, safety database support and hosting options, risk management and adverse event case management. DSA is headquartered in the Research Triangle Park region of North Carolina with strategic partnerships worldwide. For more information please visit www.DrugSafetyAlliance.com.

Media Contact:
David Menzies
Menzies Consulting, Inc.
(for Drug Safety Alliance)
dmenzies@menziesconsulting.com
(919) 274-6862

Drug Safety Alliance
Deena Wegner
919-401-8003

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