RAPS Honors Outstanding Contributions to Healthcare Product Regulatory Profession

The Regulatory Affairs Professionals Society (RAPS) today honored the recipients of its prestigious awards for outstanding contributions to the healthcare product regulatory profession.

Most honorees were presented with their awards during the opening session of 2011 RAPS: The Regulatory Convergence, which runs through 26 October at the Indiana Convention Center in Indianapolis. Two of the awards will be presented at the conference's closing session.

Following are the awards presented this morning:

The Global Leadership Award recognizes a professional whose leadership and contributions advance regulation and the regulatory profession, and increase awareness of RAPS worldwide. 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.

The New Professional Award honors an individual less than five years into his or her regulatory career for special accomplishments or exceptional service in the profession and to RAPS. This year's 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.

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 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, and worked at FDA, 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.

The Outstanding Volunteer Award is a new award developed 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.

In addition, Jos Kraus was honored with a Special European Award for his exceptional efforts in bringing together regulators and industry to advance the regulation of medical devices and move toward more globally harmonized approaches. For many years, Jos led the medical technology unit of the Dutch Ministry of Health and served as its senior inspector. He served on the GHTF steering committee and has been an active participant in RAPS.

The following will be presented, Wednesday, 26 October:

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. This year's recipient, Susan Alpert, will be honored for 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 to 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.

The newly established Honorary Fellow designation will be bestowed upon David Feigal. Feigal currently is a partner at NDA Partners. Previously, he served at FDA, where he held senior positions in all three FDA Centers including service as director of the Center for Devices and Radiological Health (CDRH); deputy director, Center for Biologics Evaluation and Research; and director of the Office of Drug Evaluation in the Center for Drug Evaluation and Research. As the director of CDRH, he was an advocate for CDRH's science and education programs and worked with Congress and industry to launch a user fee program. He served as the senior vice president for global regulatory and global safety at Élan Pharmaceutical and as the vice president for global regulatory at Amgen.

Members of the working media who wish to cover all or part of 2011 RAPS should contact Zachary Brousseau, senior manager, communications for RAPS or register on site at the Indiana Convention Center. On-site registration also will be available for media with valid press credentials or a letter from an assigning editor on company letterhead.
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