RAPS Honors Alpert, Liang, Brooke, Singer and Chamblee for Outstanding Contributions

During last month's 2011 RAPS Annual Conference in Indianapolis, IN, RAPS honored the recipients of five prestigious awards for outstanding contributions to the healthcare product regulatory profession.

The Richard E. Greco Award recognizes an outstanding leader who has made significant contributions to the regulatory profession and to RAPS, and who exemplifies personal involvement and commitment within RAPS or his community. Award winner Susan Alpert is the principle of SFA Consulting, LLC, a one-person firm focused on the strategies needed to place medical devices into the global market. She was senior vice president, global regulatory affairs at her retirement in 2011 and in this role was responsible for all Medtronic global regulatory efforts. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

The Global Leadership Award recognizes a professional whose leadership and contributions further the development of the regulatory profession and increase awareness of RAPS in societies and economies worldwide. Recipient Yan Liang is senior advisor for regulation and international affairs, Shanghai Municipal Food & Drug Administration, Shanghai Institute of Food & Drug Safety, and chairman of the Shanghai Medical Device Trade. This year, Yan worked to establish a collaborative agreement between the University of Shanghai Science and Technology (USST) and the Regulatory Affairs Professionals Society (RAPS). Currently, Yan is the director of the USST-RAPS China office.

The New Professional award recognizes professionals early in their career for exceptional service or special accomplishments in the regulatory profession and to RAPS. These professionals are viewed as promising future leaders or rising stars within the profession. Award winner M. Jason Brookehas considerable scientific research experience, including serving as a senior research scientist at Boston Scientific Corp., where, among other things, he planned, developed, coordinated and analyzed results from US and foreign clinical trials to develop automaticity features for implantable cardiac devices. While attending the University of Maryland School of Law, Brooke was the editor-in-chief of the Journal of Health Care Law & Policy.

The RAPS' Special Recognition Award acknowledges unique contributions and achievements of an individual or organization that advance the quality of healthcare and the regulatory profession. This year's honoree, Nancy Singer, founded Compliance-Alliance LLC to specialize in professional development for those employed in the drug and medical device industry. Previously she served as AdvaMed's special counsel for FDA compliance and enforcement matters. In her role as special counsel, Singer was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process. She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT).

The Outstanding Volunteer Award winner is Andrea Chamblee, RAC, FRAPS. Andrea Chamblee studied law at the University of Maryland and joined the Maryland and District of Columbia bars. She joined FDA in 1987 and now is the director of compliance policy in ORA's Office of Enforcement. She has 25 years of progressively increasing experience and responsibilities developing, communicating and implementing regulatory and compliance initiatives for FDA and industry. After five years in CBER, she worked another five years for FDA's Office of Chief Mediator and Ombudsman/Product Jurisdiction Office. After 1997, she worked in industry, analyzing and articulating compliant strategies for manufacturers and clinical investigators. She has been teaching Introduction to FDA Regulatory Affairs at Johns Hopkins University since 2005. She began the work that initiated the local Chapter of RAPS in 1999. She returned to FDA in 2009 as a regulatory counsel. She is a trans-Atlantic sailor, and is regulatory affairs certified (RAC) and was inducted into the first class of RAPS Fellows.