2012 RAPS » Experts Share this: Experts The best minds in the industry want to talk to you and listen to you. 2012 RAPS brings together experts spanning the industry and the globe, working in government agencies, industry, law firms, academia and consultancies. Participating Agencies Austrian Medicines and Medical Devices Agency, AGES PharmMed Andrea Laslop, MD, head, Institute Science and Information European Commission Jacqueline Minor, director of consumer affairs, DG SANCO, Health and Consumers Food Safety and Standards Authority of India V. Prakash, PhD, chair, Panel on Safety of Nutraceuticals and Nutritionals and Functional Foods Health Canada Agnes V. Klein, MD, DPH, director, Centre for Evaluation of Radioharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate Mike Ward, manager, International Programs Division, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate (Invited) Korea Food & Drug Administration Chung Keel Lee, PhD, special advisor to the commissioner (Invited) Youn-Joo Park, director, Cell and Gene Therapy Products Division (Invited) The National Health Surveillance Agency (ANVISA) Vivian de Morais, specialist in regulation and health surveillance, Medical Devices General Office Leticia Fonseca, head, In Vitro Diagnostic Products Office, Medical Devices General Office Joselito Pedrosa, head, Medical Devices General Office Saudi Food & Drug Authority Saleh S. Al Tayyar, PhD, executive vice president, Medical Devices Sector (Invited) US Food and Drug Administration Center for Biologics Evaluation and Research Steven R. Bauer, PhD, chief, Cellular and Tissue Therapy Branch, Division of Cellular and Gene Therapies (Invited) Barbara D. Buch, MD, associate director for medicine (Invited) Celia M. Witten, MD, PhD, director, Office of Cellular, Tissue and Gene Therapies (Invited) Center for Devices and Radiological Health John Jay Crowley, senior advisor for patient safety Ann Ferriter, director, Division of Risk Management Operations, Office of Compliance (Invited) Brian Fitzgerald, deputy director, Division of Electrical and Software Engineering, OSEL (Invited) Christy Foreman, director, Office of Device Evaluation (Invited) Sally Hojvat, PhD, director, Division of Microbiology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety (Invited) Elizabeth A. Mansfield, PhD, director, Personalized Medicine Staff, Office of In Vitro Diagnostic Device Evaluation and Safety (Invited) Bakul Patel, policy advisor (Invited) Steven Silverman, director, Office of Compliance Molly Follette Story, PhD, human factors and accessible medical technology specialist, Office of Device Evaluation (Invited) Kimberly Trautman, associate director for international affairs (Invited) Center for Drug Evaluation and Research Thomas W. Abrams, RPh, MBA, director, Office of Prescription Drug Promotion (Invited) Shashi Amur, biomarker qualification science coordinator, Office of Translational Sciences Jane A. Axelrad, JD, director, Office of Regulatory Policy Barry Cherney, PhD, deputy director, Division of Therapeutic Proteins (Invited) Dhananjay Chhatre, MS, RAC, operations research analyst, eData Management Solutions Team Leah Christl, PhD, associate director, Biosimilars Program (Invited) Beth Duvall-Miller, associate director for regulatory affairs, Office of New Drugs (Invited) M. Scott Furness, PhD, director, Division of Nonprescription Regulation Development (Invited) Valerie Gooding, regulatory information specialist, Electronic Submission Support Team Steven Kozlowski, MD, Office of Biotechnology Products (Invited) Jared Lantzy, regulatory information specialist, Electronic Submission Support Team Lisa Mathis, MD, associate director, Pediatric and Maternal Health Staff (Invited) Theresa Mullin, PhD, director, Office of Planning & Informatics Bryson Pearsall, acting director, Division of Medical Policy Programs (Invited) Judith Racoosin, MD, MPH, deputy director for safety, Division of Anesthetics, Analgesia and Addiction Products (Invited) Marjorie A. Shapiro, PhD, chief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies (Invited) Helena Sviglin, regulatory information specialist, Office of Translational Sciences Sue Jane Wang, PhD, associate director, Office of Biostatistics (Invited) Robert L. West, deputy director, Office of Generic Drugs, Office of Pharmaceutical Science Lawrence Yu, PhD, deputy director for science and chemistry, Office of Generic Drugs, Office of Pharmaceutical Science Center for Food Safety and Applied Nutrition Michael M. Landa, JD, director (Invited) Benson Silverman, MD, director, Infant Formula and Medical Foods Staff (Invited) Office of the Commissioner Murray M. Lumpkin, MD, MSc, deputy commissioner for international programs (Invited) Dianne Murphy, MD, director, Office of Pediatric Therapeutics (Invited) Thinh X. Nguyen, director, Office of Combination Products (Invited) Eric Perakslis, chief information officer and chief scientist (informatics) (Invited) Stephen Spielberg, deputy commissioner for medical products and tobacco (Invited) John (Barr) Weiner, JD, associate director for policy and product classification officer, Office of Combination Products (Invited) Office of Regulatory Affairs - Regional Field Office, Pacific Region, Oakland, CA Charles Breen, director, District Office, Seattle, WA Barbara Cassens, director, District Office, San Francisco, CA Alonza Cruse, director, District Office, Los Angeles, CA Mark S. Roh, regional food and drug director, Regional Field, Pacific Region, Oakland, CA World Health Organization Adriana Velazquez Berumen, coordinator, diagnostic imaging and medical devices, essential health technologies (Invited) Ivana Knezevic, Department of Immunization, Vaccines and Biologicals, Quality, Safety and Standards Team (Invited)
The best minds in the industry want to talk to you and listen to you. 2012 RAPS brings together experts spanning the industry and the globe, working in government agencies, industry, law firms, academia and consultancies.