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RAPS Honors Four,
Names Fellows
The Regulatory Affairs Professionals Society (RAPS) gave out four
awards for outstanding contributions
to the healthcare product regulatory
profession at its annual conference in
September.
The Global Leadership Award recognizes professionals who exemplify
leadership toward worldwide development of the regulatory profession. It
went to Salma Michor, PhD, RAC, a
consultant to the pharmaceutical and
medical device sectors on regulatory
affairs, regulatory compliance, quality
assurance, and risk management. She
has served as an independent expert for
the European Commission and teaches
regulatory affairs and clinical strategies
at the University of Krems in Austria.
The Leonard Stauffer Award recognizes contributions to mentoring and
furthering regulatory professional education. It went to Kim Walker, RAC, a
global regulatory affairs and quality assurance consultant for medical devices
and other life sciences fields.
RAPS also gave out two Special Recognition Awards for unique contributions that advance the quality of health
and regulatory affairs. They went to
Rita Hoffman and Kenichi Matsumoto.
Hoffman is the chief of CDRH’s recall
branch. She has served FDA for 30 years
and is cochair of RAPS’s Baltimore-Washington chapter. Matsumoto, who
chairs three Japanese companies, is one
of the founders of RAPS’s Japan affiliate, and is an advisor to the international committee of Japan’s Ministry of
Health, Labour, and Welfare.
RAPS also named 27 people to its recently launched fellows program. They
will serve as resources for strategic
dialogue, mentoring, and international
development. About half of the first
class of fellows has ties to the medical
device industry. —ES
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Notified Body
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that regard, but sometimes time is of
the essence and you need an even faster
turnaround. And that can buy a lot of
credibility for regulatory personnel
[within their companies].”
The keys to making the program
work, Brooks says, will be device companies providing everything required
at the start of the process and maintaining regular communication with
the notified body. “If your submission
is in order, then it should not be difficult to achieve a resolution within the
[ 45 working day] time frame,” he says.
“It rests on the quality of the submission. But at least everyone will know
where they stand.”
In order to have adequate resources
for the program, BSI has added to its
technical review staff Brooks notes.
—Erik Swain ■
