'Investigational drugs' diaporamas de présentation

expanded access to investigational drugs; background & issues

WELCOME. expanded access to investigational drugs; background & issues. Diane e. Dorman, National organization for rare disorders. PANELISTS. Sascha Haverfield, Ph.D. Vice President for Scientific Regulatory Affairs, PhRMA Richard Klein, Director, FDA Patient Liaison Program

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Introduction to the Clinical Research Centers and Clinical Research Unit

Introduction to the Clinical Research Centers and Clinical Research Unit . Agenda. Overview Administrative Issues Role of the Research Subject Advocate Nursing Policies and Procedures Bionutrition Specimen Processing Gateway Services Statistics, Information Technologies

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How to Maintain Responsible Conduct in Research - Part 2

How to Maintain Responsible Conduct in Research - Part 2. Human Subjects and Animal Welfare Lauren Solberg Clinical Research Center Research Skills Workshop January 25, 2008. Office of Research Integrity (ORI). http://ori.dhhs.gov

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Good Clinical Practice: Are We There Yet ? And What Comes Next ?

Good Clinical Practice: Are We There Yet ? And What Comes Next ?. David A. Lepay, MD PhD Senior Advisor for Clinical Science Office of the Commissioner, US FDA July 25, 2007. What This Talk Will Cover. Introduction to FDA FDA Expectations and Oversight in Clinical Research

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Institutional Responsibilities for Research

Institutional Responsibilities for Research. K. Lynn Cates, MD Assistant Chief Research & Development Officer. Bottom Line. Each VA facility must assume responsibility for all its research Medical Center Director and ACOS/R&D have ultimate responsibility for what happens

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Childcare Provider Education: Regulations and Policies Lead and Beyond Conference April 16, 2010

Childcare Provider Education: Regulations and Policies Lead and Beyond Conference April 16, 2010. Mary E. Coogan, Esq. Association for Children of NJ mcoogan@acnj.org. Mary Coogan Conflict of interest statement . As required:

387 views • 30 slides

THE POISON PREVENTION PACKAGING ACT

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THE POISON PREVENTION PACKAGING ACT

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Single-Patient Use of Investigational Drugs and Biologic Products for Treating Cancer

Single-Patient Use of Investigational Drugs and Biologic Products for Treating Cancer. Grant Williams, M.D. Medical Team Leader DODP/CDER/FDA. Objectives. Educate the public Provide advice to FDA. Agenda. FDA introduction Ethical framework Industry perspective

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Manufacture of Phase I Investigational Drugs Exemption from Requirements of Part 211

Manufacture of Phase I Investigational Drugs Exemption from Requirements of Part 211. July 9, 2008 Federal Register Notice. Announced amendment to 21CFR Part 210 to add paragraph (c)

440 views • 11 slides

AU Meds and JCAHO Med Management Standards

AU Meds and JCAHO Med Management Standards. 7.10 Processes for managing high-risk, high-alert meds. 2.10 Process to monitor drugs before and after addition to formulary: High risk of error?. 3.20 Med orders are written clearly and/or transcribed accurately 4.40 Meds are dispensed safely.

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Clinical Resources: LLUMC Investigational Drug Service

Clinical Resources: LLUMC Investigational Drug Service. Desiree Wallace, Pharm.D. Objectives: To describe the availability of the IDS for research on campus To discuss how one can collaborate and access the IDS to enhance research activities. 2016 Research Affairs Symposium October 21, 2016.

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Study Sponsors

Contact Information for a Clinic Near You: Insert clinic info/ coordinator info/ etc. A Study for Women with Newly Diagnosed Breast Cancer Will it be possible to personalize treatment for breast cancer? Would you be interested in joining a trial trying to answer that question?.

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Probability of Success for Investigational Drugs is Small

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