Each year, when the recipients of RAPS' prestigious annual awards for outstanding contributions to the regulatory profession take the stage at RAPS' annual Regulatory Convergence conference, they find themselves somewhere unfamiliar to most regulatory professionals-in the spotlight. Annually, RAPS bestows upon a select group of worthy honorees, several awards for exemplary professional leadership, volunteerism, mentoring and advancement of the regulatory profession, which itself is not often celebrated for its important role in bringing safe, effective and at times, innovative medicines and medical products to market. Regulatory Focus took a moment to reflect on the 2012 honorees and the awards they received.
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 to RAPS and his or her own community. In 2012, it was awarded to Virginia Perry, RAC, CQE, FRAPS, president, Perry-D'Amico & Associates. Perry is founder of and partner in Perry-D'Amico & Associates, a regulatory and quality management consulting firm specializing in medical devices. She is the founder and a director of the RAPS San Francisco Bay Area Chapter, one of RAPS' oldest and most active local groups, and has served on the RAPS board of directors and as an important advisor to the board. She also has served on RAPS' National Chapter Advisory Board, Regulatory Affairs Certification Board and on numerous educational program committees.
"I am humbled and honored to be the recipient of this award," said Perry. "It means a lot to me to be recognized for leadership within the field and for my contribution to the regulatory profession and to RAPS. I am very grateful to RAPS and the nominating committee for recognizing my contributions and choosing me to receive the 2012 Richard E. Greco award."
The Leonard Stauffer Award honors exceptional contributions to mentoring and furthering regualtory professional development. Clare Matti, MA, RAC, assistant director, regulatory services, Duke Clinical Research Institute, received this honor last year. Matti has been a leader in the design and implementation of education programs to enhance the knowledge and abilities of professionals working in regulatory environments in the EU and Canada. She holds the US and EU Regulatory Affairs Certification (RAC) credential, and for six years has led a series of 12-week courses on US, EU and Canadian regulations. She also serves as an advisor on regulations to several startup companies in North Carolina, where she continues to be a teacher, mentor and guide on good regulatory practice.
"I am honored and humbled to have been nominated by peers who attended the courses for RAC exam prep," said Matti. "As a recipient of the Leonard Stauffer Award, I can express my appreciation to those who mentored me and encouraged me to further my regulatory professional development even while I 'pay it forward' to the next generation of mentors and educators. The Regulatory Affairs Certification distinguishes dedicated and accomplished regulatory professionals. I am delighted to promote the RAC to my colleagues."
RAPS' Outstanding Volunteer Award was developed by RAPS chapters to recognize the vital efforts of members at the local level. Leslie Sands, RAC, director, regulatory affairs, Lupin Pharmaceuticals, received this honor last year for her dedication and enthusiasm in supporting the RAPS DC/Baltimore Chapter. Sands leads RAC study groups, and is an expert and frequent speaker on the topic of generic medicines. Her dedication to the chapter's success is evident in her continuous efforts coordinating study groups, writing announcements, recruiting volunteers and speakers, and reaching out to first time attendees of chapter events.
"Receiving the RAPS Outstanding Volunteer Award means that not only have I met my goal, but I've helped someone else meet theirs in the process," remarked Sands.
The Special Recognition Award recognizes the unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory. David Vulcano, LCSW, MBA, CIP, RAC, assistant vice president and responsible executive, clinical research, Hospital Corporation of America, received the award for his exceptional work in innovating regulatory processes. Vulcano is a leader in the clinical research area and has been instrumental in building strong connections and seamless integration between clinical research and regulatory professionals in North America and in Europe.
"It is a testimony that regulatory affairs is not just an obligation of-or profession limited to-employees of research sponsors," said Vulcano of his award. "There is a growing need to recognize and promote the role regulatory affairs professionals play in all aspects of medical care and research."
Finally, RAPS' Global Leadership Award recognizes professionals who exemplify leadership and contribute to the development of the regulatory profession globally and increasing awareness of RAPS worldwide. The 2012 recipient was Mike Ward, manager, International Program Bureau of Policy, Science and International Programs Division, Health Canada. Ward has been an active leader and advisor to global health organizations and to RAPS. He serves on the RAPS Global Advisory Council, and has played a critical role in the World Health Organization, the Pan American Health Organization and to individual nations in Asia, Latin America and Africa. He serves in leadership roles with the International Medical Device Regulators Forum, on the medical device side, and with the International Conference on Harmonisation on the pharmaceutical side. He also chairs regulatory groups within the Asia-Pacific Economic Cooperation. He is a strong advocate of the development of good regulatory practices around the world and of competent professionals who can implement such practices.
Each of these honorees has helped move the regulatory profession forward in one way or another, and is deserving of a little time in the spotlight.