Released on: October 7, 2008, 6:24 am

Press Release Author: David Menzies for Drug Safety Alliance

Industry: Pharmaceuticals

Press Release Summary: Pharmaceutical Safety Company Shares Insight into European
Quality Assurance Regulations

Press Release Body: (Research Triangle Park, N.C.) – October 7, 2008 -- 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. For more
information please visit www.DrugSafetyAlliance.com.

Media Contact:

David Menzies
Menzies Consulting, Inc
dmenzies@menziesconsulting.com
(919) 274-6862

Drug Safety Alliance
Deena Wegner
919-401-8003



Web Site: http://www.drugsafetyalliance.com

Contact Details: 105 Pinewood Dr.
Apex, NC 27502
919-373-4274
dmenzies@menziesconsulting.com