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 DIGEMID Lida E. Pinedo Hilderbrant, executive management and health surveillance control, General Directorate of Medicines, Devices and Drugs European Commission Jacqueline Minor, director of consumer affairs, DG SANCO, Health and Consumers European Medicines Agency (EMA) Laurent Brassart, scientific administrator, information, compliance and consistency, medical information sector Gunter Egger, DVM, scientific administrator/paediatric coordinator, Human Medicines Special Areas Sector, Pediatric Section Alberto Ganan Jimenez, PhD, scientific administrator, Quality of Medicines Sector–Biological, Human Medicines Development and Evaluation Unit Steffen Gross, PhD, EMA quality assessor Federal Trade Commission Robert J. Schroeder, director, Northwest Region Food Safety and Standards Authority of India Vish Prakash, PhD, chair, Panel on Safety of Nutraceuticals and Nutritionals and Functional Foods Health Canada Michelle Crozier, senior policy analyst, Bureau of Policy, Science & International Programs, Therapeutic Products Directorate, Health Products and Food Branch Agnes V. Klein, MD, DPH, director, Centre for Evaluation of Radioharmaceuticals and Biotherapeutics, Biologics and Genetic Therapies Directorate Christopher Rose, manager, Medical Device Compliance Unit, Compliance and Enforcement Coordination Division, Health Products and Food Branch Inspectorate Mike Ward, manager, International Programs Division, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate William Yan, director, Bureau of Nutritional Sciences, Food Directorate Medicines and Healthcare Products Regulatory Agency (MHRA) Neil Ebenezer, PhD, head of new and emerging technologies, Devices Division Susanne Ludgate, medical director of devices Bruce Petrie, compliance unit manager National Institute of Nutrition and State Foods, China CDC Xiaoguang Yang, MD, PhD, professor Pharmaceuticals and Medical Devices Agency (PMDA) Daisuke Fujisawa, PhD, reviewer, Office of Medical Devices I Takako Nakayama, DVM, reviewer, Office of Medical Devices II Mari Shirotani, deputy inspection director, Office of Conformity Audit Kyoichi Tadano, PhD, special technical expert, Office of Standards and Guidelines Development Saudi Food & Drug Authority Saleh S. Al Tayyar, PhD, executive vice president, Medical Devices Sector State Food and Drug Administration Yongheng Chang, deputy director general Xiaoli Du, deputy staff, Center for Medical Device Evaluation Xiaolei Guo, reviewer, Center for Medical Device Evaluation Weigang He, deputy section chief, Center for Medical Device Evaluation Guoying Jin, investigator, Bureau of Investigation & Enforcement Aijun Wu, section chief, Department of Medical Device Supervision US Food and Drug Administration Center for Biologics Evaluation and Research Barbara D. Buch, MD, associate director for medicine, Office of the Center Director Peter F. Bross, MD, medical review officer, Office of Cellular, Tissue and Gene Therapies Nicole Trudel, quality assurance specialist, Office of Compliance and Biologics Quality, Division of Manufacturing and Product Quality Ramjay Vatsan, PhD, biologist, Office of Cellular, Tissue and Gene Therapies, Division of Cellular and Gene Therapies 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 Brian Fitzgerald, deputy director, Division of Electrical and Software Engineering, OSEL Christy Foreman, director, Office of Device Evaluation Elizabeth A. Mansfield, PhD, director, Personalized Medicine Staff, Office of In Vitro Diagnostic Device Evaluation and Safety Bakul Patel, policy advisor, Office of the Center Director Steven D. Silverman, JD, director, Office of Compliance Jan Welch, deputy director, regulatory affairs Barbara Zimmerman, deputy director for premarket program management, Office of Device Evaluation Center for Drug Evaluation and Research Shashi Amur, science coordinator, Biomarker Qualification Program, Office of Translational Sciences Barry Cherney, PhD, deputy director, Division of Therapeutic Proteins, Office of Biotechnology Products (Invited) Dhananjay Chhatre, MS, RAC, operations research analyst, eData Management Solutions Team Beth Duvall, associate director for regulatory affairs, Office of New Drugs M. Scott Furness, PhD, director, Division of Nonprescription Regulation Development Valerie Gooding, regulatory information specialist, Electronic Submission Support Team Murewa Oguntimein, social science analyst, Division of Medical Policy Programs, OMPI Steven Kozlowski, MD, director, Office of Biotechnology Products (Invited) Jared Lantzy, regulatory information specialist, Electronic Submission Support Team Rikin S. Mehta, deputy director, Division of Medical Policy Programs, Office of Medical Policy, Office of Medical Policy Initiatives Theresa Mullin, PhD, director, Office of Planning & Informatics Bryson Pearsall, director, Division of Medical Policy Programs, OMPI Colleen Ratliffe, project manager, Legacy Data Conversion Project, Office of Translational Sciences Sue Jane Wang, PhD, associate director, Office of Biostatistics Robert L. West, deputy director, Office of Generic Drugs, Office of Pharmaceutical Science Lane Christensen, PhD, Immediate Office, 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 Office of the Commissioner Peter C. Beckerman, JD, senior policy advisor, Office of Policy Thinh X. Nguyen, director, Office of Combination Products John (Barr) Weiner, JD, associate director for policy and product classification officer, Office of Combination Products Office of Regulatory Affairs Dorothy Lee, supervisor, Dedicated Foreign Medical Device Cadre, DFFI Howard Sklamberg, deputy associate commissioner for regulatory affairs Office of Regulatory Affairs - Regional Field Office, Pacific Region, Oakland, CA Alonza Cruse, director, District Office, Los Angeles, CA Mark S. Roh, regional food and drug director, Regional Field, Pacific Region, Oakland, CA Washington State Health Care Authority Josh Morse, MPH, program director, WA Health Technology Assessment Program
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.