Richard E. Greco Award
The Richard E. Greco Award is the highest honor bestowed by RAPS. It 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 or her own community. Richard Greco founded RAPS and is credited with foreseeing the need for a society to represent a profession that grew quickly when the Medical Device Amendments were passed in 1976. He worked with a small group of volunteers to create the society, established career paths for regulatory professionals, opened a dialogue with the FDA and built professional development training and education.
The 2011 recipient of the Greco award, Susan Alpert, was bestowed the award in recognition of her distinguished career and as an advocate for the vital role of the regulatory profession. Alpert is a microbiologist and pediatrician with a specialty in infectious diseases. She is the principle of SFA Consulting LLC, working with clients on regulatory strategies to place medical devices into the global market. Her career spans industry, regulatory agency staff, clinician and researcher. Recently retired from her role as chief regulatory officer at Medtronic, she also worked at FDA in the centers dealing with drugs, devices and radiological health and foods, including six years as the director of the Office of Device Evaluation.
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Global Leadership Award
The Global Leadership Award recognizes a professional whose leadership and contributions advance regulation and the regulatory profession, and increase awareness of RAPS worldwide.
In 2011, Yan Liang, senior advisor for regulation and international affairs, Shanghai Municipal Food and Drug Administration (SMFDA) in Shanghai, China, received this honor. He previously led SMFDA’s medical device oversight and currently is chairman of the Shanghai Medical Device Trade Association. He was honored in recognition of his efforts to organize a group to draft and implement China’s first medical devices regulations and his role as a leader in the area of universal device identifiers at the Global Harmonization Task Force (GHTF) and the Asian Harmonization Working Party. To improve China’s international medical device trade, he led the effort to create a Center for Medical Device International Trade (CMDIT) in Shanghai’s Free Trade Zone. For the past two years, Yan worked to establish a collaborative agreement between the University of Shanghai for Science and Technology and RAPS, and he serves as the director of the USST-RAPS China office.
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New Professional Award
The New Professional Award honors an individual less than five years into his or her regulatory career for special accomplishments or exceptional service to the profession and to RAPS.
In 2011 the award went to M. Jason Brooke, an associate in the Health Care and Life Sciences practice in Epstein Becker Green’s Washington, DC, office. Previously, Jason was a program analyst at the US Food and Drug Administration (FDA) in its Center for Devices and Radiological Health, reviewing proposed and final rules and guidance documents for regulatory compliance. He also served as a senior research scientist at Boston Scientific Corp.
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The Special Recognition Award recognizes unique contributions and achievements of individuals who advance the quality of health and regulatory and demonstrate special service to RAPS.
Nancy Singer, founder of Compliance-Alliance, was honored in 2011 for her dedication as a tireless and productive volunteer for RAPS and the profession. Singer previously served as special counsel at the Advanced Medical Technology Association, where she was involved in development of the Quality System Inspection Technique or "QSIT." She has taught food and drug law at several universities and chaired the Food and Drug Law Section of the Federal Bar Association. She chairs the RAPS DC/Baltimore Chapter and regularly speaks to chapters and groups of regulatory professionals across the US.
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Leonard Stauffer Award
The Leonard Stauffer Award recognizes exceptional contributions to mentoring and furthering regulatory professional education development, including special achievements related the Regulatory Affairs Certification (RAC).
Nanci Dexter received the Leonard Stauffer Award in 2009. Ms. Dexter is an independent global regulatory affairs and quality assurance consultant. Her work experience over the past 25 years includes IVDs, biologics, pharmaceuticals, and medical devices in both startup and large company environments. Ms. Dexter has served on the Rocky Mountain Regulatory Affairs Society (RMRAS) as the Regulatory Affairs Certification (RAC) Chair for the past 6 years promoting the RAC through multi-week study groups. Additionally, she served on the Steering Committee for over 10 years and was the president of RMRAS from 2000-2004. Ms. Dexter has earned both the US and EU RAC certifications. She holds a BS in Finance from Colorado State University and has attained the CMQOE, CQIA, and CQA certifications from American Society For Quality (ASQ).
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Outstanding Volunteer Award
The Outstanding Volunteer Award is a new award developed in 2011 by RAPS chapters to recognize the vital efforts of members at the local level.
The inaugural recipient is Andrea Chamblee, nominated by the RAPS DC/Baltimore Chapter. Chamblee is the director of compliance policy in FDA’s Office of Enforcement. She has 25 years of experience with the agency and in industry. She has been teaching Introduction to FDA Regulatory Affairs at Johns Hopkins University since 2005. In 1999, she began the groundwork that initiated the RAPS DC/Baltimore Chapter and played an active leadership role for 10 years, stepping down as chair in 2009. She continues to lead Regulatory Affairs Certification (RAC) study groups and has actively promoted the regulatory profession and RAPS.
Nominees for the Outstanding Volunteer Award are selected by representatives of the chapters.
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