Pharmaceutical Safety Company Shares Insight Into European Quality Assurance Regulations

Drug Safety Alliance (DSA), a global
leader in pharmaceutical safety and pharmacovigilance, was invited to
share their extensive insight into quality assurance protocols in
Europe with the Regulatory Affairs Professionals Society (RAPS) at
their annual conference held recently in Boston.



Conference presenter Joseph Knight-McKenna (MBA, CQM/OE, CQA, CSQE,
RAC), DSA's senior director, Quality and Regulatory Compliance,
educated attendees on tools and strategies for selecting a qualified
team responsible for pharmacovigilance (QPPV), analyzing existing
pharmacovigilance systems, and incorporating regulations from the
European Union into processes and procedures.



"There is a great deal of concern about meeting the guidelines of the
European Union's 'Volume 9A'," Knight-McKenna explained following his
detailed presentation which included an overview of pharmacovigilance
system requirements as well as components of a regulatory compliance
process map. "We understand the challenges of international
pharmaceutical organizations and the myriad of reports that must be
generated for compliance in the U.S. and abroad. We pride ourselves
on the ability to make life easier for clients in that situation by
pulling together their data and streamlining it for a more smooth
reporting process."



"The feedback we're getting through our active engagement in the
regulatory affairs industry tells us there is a need for access to the
type of guidance that Joe presented at RAPS," said Cathy Stokes,
president and CEO of Drug Safety Alliance. According to Stokes, her
organization has plans to share similar insight through multiple
seminars and presentations in the coming months and into 2009.



Knight-McKenna will also be presenting at the American Society for
Quality's 17th Annual Audit Division Conference in Augusta, Georgia on
October 16.



Knight-McKenna is responsible for Drug Safety Alliance's Quality
Management System, Corrective and Preventive Action (CAPA) system,
auditing programs and quality procedures. He has been Regulatory
Affairs Certified (RAC) 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.

Drug Safety Alliance