Slide 1An Overview of the United States Regulatory Environment (FDA and Healthcare) for Global Pharmaceutical Compliance Professionals May 28, 2008 Lynn Shapiro Snyder, Esq.…
Slide 1Constructing Safety Assurance Cases for Medical Devices Arnab Ray, PhD Senior Research Scientist Fraunhofer USA Center for Experimental Software Engineering Rance…
Slide 1Office of Science and Technology Center for Devices and Radiological Health, FDA William A. Herman eHealth Technologies and the FDA Slide 2 CDRH TECHNOLOGY FORECAST…
1. Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies Marybeth Gamber Senior Regulatory Consultant Boston Biomedical Associates…
Slide 1"Determining the Regulatory Pathway to Market" Classification Heather S. Rosecrans Director, 510(k) Staff Office of Device Evaluation Center for Devices…
Medicare Submission for Pre-Approval in Clinical Research Ronda Sharp, R.N., B.S.N., C.C.R.C. Clinical Research Facilitator Methodist Research Institute History of Pre-Approval…
Intranasal Medications in clinical practice Transmucosal medication delivery Is this really a novel idea? Commercially available transmucosal drugs: Actiq oral (transmucosal…
Office of Science and Technology Center for Devices and Radiological Health, FDA William A. Herman eHealth Technologies and the FDA CDRH TECHNOLOGY FORECAST Computer-related…
Slide 1 Constructing Safety Assurance Cases for Medical Devices Arnab Ray, PhD Senior Research Scientist Fraunhofer USA Center for Experimental Software Engineering Rance…