NEWS TRENDS

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.

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