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1. Introduction to Research Pharmacy Investigational Drug Control and Patient SafetyCUMC RPRobert B. MacArthur, Pharm.D. 2. “ Why does it take so long and cost so much…

Documents 14 Jones Case Studies Reviewed

Working with FDA: Biological Products and Clinical Development IND Case Studies Karen D. Jones Chief, Project Management Staff Division of Biologic Oncology Products Office…

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1. An exposure control plan must be established in writing-Determine exposures-Procedure’s for evaluating exposures-How and when the exposure methods are to beused.-The…

Health & Medicine Mast apr13pres

1. NYSE MKT: MSTXNYSE MKT: MSTXCorporate OverviewApril 3, 2013Brian M. Culley, CEO 2. NYSE MKT: MSTXForward-Looking Statements2This presentation includes forward-looking…

Documents Drug Advertising & Promotion: A Practical Guide to Compliance Philip KatzOctober 20, 2011 Partner...

Slide 1Drug Advertising & Promotion: A Practical Guide to Compliance Philip KatzOctober 20, 2011 Partner Hogan Lovells US LLP Slide 2 www.hoganlovells.com 22 Agenda Back…

Documents Understanding Research: Getting Your Project Ready for the IRB Jill Stoltzfus, Ph.D. Director,...

Slide 1Understanding Research: Getting Your Project Ready for the IRB Jill Stoltzfus, Ph.D. Director, Research Institute [email protected] Slide 2 Todays Objectives Present…

Documents Human Investigation Committee 2013. Is It Research? Is It Human Subjects Research? Is It Human...

Slide 1Human Investigation Committee 2013 Slide 2  Is It Research?  Is It Human Subjects Research?  Is It Human Subjects Research that requires IRB review? Slide…

Economy & Finance Regulatory Framework: SOPs For Ethical Regulation Of Drugs

1.Standard Operating Procedures R E G U L A T O R YA F F A I R S BII INDUSTRY PROGRAME IN PHARMA REGULATORY AFFAIRS2. INDEX 1 Introduction 2 Standard Operating Procedures3…

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1. “The Facility’s Perspective” (FDA) Inspections 2. The SpeakerPatrick R. Ayd RN, MBA2 3. The Facility‘s PerspectiveHow to prepare for an FDA Inspection Understanding…

Business Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics Development

1. Regenerative Medicine: Impact of Convergence on Drug, Device and Biologics Development Annemarie Moseley, PhD, MD Acting CEO, Aggregate Therapeutics, Inc. 2. It’s a…