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Documents ClinicalTrials.gov Why Does it Affect Me? Should I Be Concerned? Presenter Name and contact Info.

Slide 1ClinicalTrials.gov Why Does it Affect Me? Should I Be Concerned? Presenter Name and contact Info Slide 2 Be aware that… Any PowerPoint presentation can only be an…

Health & Medicine mHealth Israel_Physio Logic_US and EU Digital Health Regulatory Landscape

1. Digital Health – The Regulatory Landscape Jerusalem, June 29th, 2015 Gadi Ginot, CEO This presentation is the sole property of Physio-logic Ltd and is protected by Copyright…

Documents How the Past Influenced Human Research Protection Regulations Shirley J. Hicks Director, Division of...

Slide 1 How the Past Influenced Human Research Protection Regulations Shirley J. Hicks Director, Division of Education and Development Office for Human Research Protections…

Documents Constance Lewin, M.D., M.P.H. Associate Director for Human Subject Protection Acting Branch Chief,.....

Slide 1 Constance Lewin, M.D., M.P.H. Associate Director for Human Subject Protection Acting Branch Chief, Good Clinical Practice Branch 1 Division of Scientific Investigations…

Documents Council for Responsible Nutrition Supplyside West, October 19, 2006 The Case for Mandatory Reporting...

Slide 1 Council for Responsible Nutrition Supplyside West, October 19, 2006 The Case for Mandatory Reporting of Adverse Events for Dietary Supplements Steve Mister President…

Documents Human Research Protection Program 101 March 19-20, 2007 Cincinnati, Ohio.

Human Research Protection Program 101 March 19-20, 2007 Cincinnati, Ohio The Drug Side of FDA Regulations, with a Few Mechanics C. Karen Jeans, MSN, CCRN COACH Project Analyst…

Documents Exempt and Expedited Reviews What Requires IRB and R&D Approvals

Exempt and Expedited Reviews What Requires IRB and R&D Approvals Kimberly Summers, PharmD Deputy ACOS for Research and Development South Texas Veterans Health Care System…