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The Drug Safety Institute (DSI), a subsidiary of Brand Institute,
was created in 2004. DSI is dedicated to improving the safe use of
Pharmaceuticals by providing a global, state-of-the-art, research
model for proprietary (brand and line extension) and nonproprietary (USAN/INN) nomenclature research. In addition, DSI offers a
medication error prevention analysis associated with labeling of
pharmaceuticals, biological products and medical devices. DSI also
offers various risk management strategies to our clients.
Drug Safety Institute Services
STRATEGY
USAN / INN / STEM / CLASS NAME
NAME SAFETY RESEARCH
GAP ANALYSIS
REGULATORY STRATEGY CONSULTS AND REBUTTAL
NAME SAFETY REPORTS / SUBMISSION
PROMOTIONAL / ADVERTISING RESEARCH
FAILURE MODE AND EFFECTS ANALYSIS
RISK MANAGEMENT PLANS
PRODUCT LABELING, PACKAGING AND TRADE DRESS RESEARCH
REGULATORY / SAFETY REVIEW OF CONTAINER AND CARTON LABELS AND PACKAGING
NONPROPRIETARY (USAN / INN) NAME RESEARCH
At DSI our plan is to make the Brand Institute methodology for
proprietary and non proprietary name safety testing even more
reflective of the FDA and other regulatory agencies’ review processes.
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Jerry Phillips, R.Ph.
President & CEO
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Jerry Phillips' Biography
Mr. Phillips retired from the U.S. Public Health Service at the Food and
Drug Administration (FDA) in 2004, after 16 years with the Agency.
Joining the Agency in 1988, he became the Director of the Division of
Labeling and Program Support in the Office of Generic Drugs, where
he shared responsibility for the approval of all generic drugs in the U.S.
In particular, he developed his expertise in the labeling and safe use of
pharmaceutical products. In December of 1998, he became the
Associate Director for Medication Error Prevention in the newly created
Office of Post-Marketing Drug Risk Assessment (OPDRA), which
is now known as the Office of Drug Safety (ODS). During his 6 years
with ODS, he created and became the Acting Director of the Division
of Medication Errors and Technical Support (DMETS), responsible for
the review and analysis of all proprietary names in the United States.
While with the ODS, he developed the methodology that the FDA
uses in testing all U.S. proprietary names for safe use.
Mr. Phillips’ leadership in preventing medication errors has included
work on a plethora of projects and committees stateside, including the
recent Bar Coding Rule published by the FDA. In addition, he was the
Chair of the Medication Errors Committee in the FDA ’s Center for
Drug Evaluation and Research; Chair of the National Coordinating
Council for Medication Error Reporting and Prevention (NCC MERP);
principal author of the Taxonomy of Medication Errors created by
NCC MERP; member, NIOSH Working Group on Hazardous Drugs;
and member, Department of Defense (DoD) working group to establish
pharmaceutical bar coding in the DoD.
Mr. Phillips earned his B.S. in Pharmacy from the University of Houston
and completed an ASHP hospital pharmacy residency at the U.S.
Public Health Service hospital in Staten Island, N.Y.
Mr. Phillips oversees all proprietary & nonproprietary strategy, naming,
safety research, labeling, risk management, name submissions, rebuttals,
and special consults for DSI.
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