RAPS 2012 Session Schedule

Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health LLC. Rosecrans continues her commitment to public health at Greenleaf where she provides strategic consulting services and works with Greenleaf clients to bring innovative devices to patients. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements. Rosecrans started her FDA career as a biologist in the agency’s Bureau of Medical Devices – prior to the formation of CDRH. In 1980, Rosecrans joined the newly organized CDRH Premarket Application (PMA) Staff. For the next seven years, she coordinated the administrative, scientific and regulatory review of PMAs, product development protocols and associated submissions. In 1987, Rosecrans joined the 510(k) Section of CDRH’s Program Operations Staff (POS). In this role, Rosecrans served as a Consumer Safety Officer and was a key contact for CDRH and FDA on 510(k) matters. Rosecrans held this position until 1992, at which time she became Director of the 510(k) Staff. Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Since the program’s inception in 1976, more than 120,000 products have been cleared via the 510(k) program. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies. Rosecrans holds a Bachelor of Science in Biology from Pfeiffer College in Misenhelmer, NC.

Chadwick is the director, regulatory affairs/ regulatory science at Cook, Inc. He is responsible for developing regulatory strategy for emerging and marketed products within the company and for regulatory submissions/compliance. He has over 25 years of experience in the medical device industry in such areas as basic research and development, clinical research, and for the past 15 years, regulatory affairs/quality assurance. The scope of his experience includes the product areas of dermatology, in vitro diagnostics, urology, cardiology, drug delivery, electrosurgery and drug-eluting stents. Dr. Chadwick spent many years in research and development functions and managing clinical trials prior to transitioning into regulatory affairs. Dr. Chadwick received a BS in biology from Albright College and a PhD in Anatomy and Cell Biology from the School of Medicine, University of Pittsburgh.

vice president, medical device quality systems, Quintiles Consulting works with clients in the medical device, pharmaceutical and biotechnology industry to develop quality assurance, manufacturing and regulatory strategies for compliance with FDA regulations. She conducts regulatory gap analysis, assists with the development and implementation of quality systems and corrective action plans to address deficiencies identified by regulatory agencies. Messa joined Quintiles Consulting following a 30 year career with FDA. Most recently, Messa was the director of FDA’s Los Angeles District. She chaired ORA/CDRH Medical Device Field Committee and participated in the development and implementation of the Quality Systems Regulation, Mutual Recognition Agreement (MRA) and Quality Systems Inspection Technique (QSIT). She is a member of Regulatory Affairs Professionals Society (RAPS) and the Food and Drug Law Institute (FDLI).

Yeager joined Lilly in 1986 as a Biomedical Engineer in Cardiovascular Toxicology. As a founding member of Lilly's drug delivery device organization group, Hal ran the development of Lilly's first prefilled insulin pen-injector (HumaJect, 1995) and Lilly's first reusable insulin pen-injector (HumaPen Ergo, 1998). Following a brief stint in US Regulatory Affairs, Hal established a device group within Global Product Safety where he led the development of a combined global product complaint and adverse event infrastructure as well as Lilly's device reporting and surveillance capabilities. Hal has been actively involved with ISO Technical Committee 84 (Devices for the administration of medicinal products and intravascular catheters) for close to 20 years where he is currently Chairman. Hal received his undergraduate degree in Natural Sciences/Biology from Muhlenberg College in 1981 and his graduate degree in Biomedical Engineering from Drexel University in 1986.

Fairfield completed her undergraduate studies at Indiana University, Bloomington, and her post-baccalaureate studies at Indiana University and Indiana University-Purdue University Indianapolis, and St. Francis Hospital and Healthcare, Indianapolis. Following seven years in the pharmaceutical industry, she joined Eli Lilly and Company in 2008 in US Regulatory Affairs as a senior regulatory associate, where she focused on the cardiovascular, endocrine, and osteoporosis therapeutic areas. She also has served as a consultant on early phase molecule development. She is currently a Principal Consultant in Global Regulatory Affairs, where she provides advertising and promotion guidance and strategy for Lilly's diabetes portfolio, as well as US labeling support for the endocrine platform. She is a certified medicolegal forensic investigator for Indiana and is also actively employed in Emergency Medical Services.