'Investigational new drug application' diaporamas de présentation

REGULATORY COURSE

REGULATORY COURSE. REGULATORY REQUIREMENTS AND STRATEGIES. REGULATORY COURSE. REGULATORY COURSE. Sponsor Activities: Preclinical Investigations: Identify potential effects of the drug or biologic in the body using laboratory and animal testing Pharmacology, Toxicology

1.44k views • 116 slides

Food and Drug Administration (FDA): FDA overview and Bioresearch Monitoring

Food and Drug Administration (FDA): FDA overview and Bioresearch Monitoring. CDR Tejashri Purohit-Sheth, M.D. Branch Chief, Good Clinical Practice II Division of Scientific Investigations Center for Drug Evaluation and Research Food and Drug Administration. Outline. FDA Overview History

1.09k views • 59 slides

Development and Approval of Drugs and Devices EPI260 Lecture 1: Overview April 1, 2010 Richard Chin, M.D.

Development and Approval of Drugs and Devices EPI260 Lecture 1: Overview April 1, 2010 Richard Chin, M.D. Course Objective. Provide a survey of drug and device development from late preclinical through Phase 3 clinical studies. Course Outline. Overview

759 views • 54 slides

What is an IND?

What is an IND?. Keith Wonnacott, Ph.D. Division of Cellular and Gene Therapies Office of Cellular, Tissue, and Gene Therapies Center for Biologics Evaluation and Research FDA. Basis for Regulation of INDs. Statutes: THE LAW --- passed by Congress and signed by the President

786 views • 53 slides

Research Involving Human Subjects

Research Involving Human Subjects. Institutional Review Board (IRB) Judette Haddad, PhD, CIP. History and Ethical principles. Nuremberg Code 1947 Declaration of Helsinki 1964 National Research Act 1974 Belmont Report 1979 Respect for person- Informed consent

517 views • 40 slides

Overview of Good Clinical Practices (GCPs)

Overview of Good Clinical Practices (GCPs). Barbara Pennington, RN, MS PPD. Why Regulate Clinical Research?. Ensure the rights, safety, and well-being of participants Scientific Integrity of data. Good Clinical Practices (GCPs).

576 views • 40 slides

Human Research Protection Program 101

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. What This Talk Will Cover. The mystique of the Investigational New Drug Application (IND) IND Emergency IND

1.44k views • 39 slides

Clinical Review Process: An FDA Perspective

Clinical Review Process: An FDA Perspective. Karen Midthun, M.D. Deputy Director of Medicine Center for Biologics Evaluation and Research FDA April 15, 2005. Biological Products Regulated by CBER. Blood, blood components and derivatives Vaccines (preventive and therapeutic) Allergenics

810 views • 39 slides

CLINICAL TRIALS 101

CLINICAL TRIALS 101. History

1.19k views • 35 slides

Introduction to GCP and 21CFR312

465 views • 32 slides

Antibiotics

Antibiotics Overview If bacteria make it past our immune system and start reproducing inside our bodies, they cause disease. Certain bacteria produce chemicals that damage or disable parts of our bodies.

1.57k views • 28 slides

Principles for cli nical evaluation of vaccines: WHO guidelines

World Health Organization - WHO. Principles for cli nical evaluation of vaccines: WHO guidelines. Dr Ivana Knezevic WHO, Immunization, Vaccines & Biologicals Quality Assurance and Safety of Biologicals . Vaccine development and evaluation. Preclinical/ Nonclinical testing. Characteri

1.23k views • 28 slides

302 views • 23 slides

INVESTIGATIONAL DRUG SERVICES IN THE HOSPITAL

INVESTIGATIONAL DRUG SERVICES IN THE HOSPITAL. Sheree Miller, Pharm.D. University of Washington Medical Center 1-13-04. What is an Investigational Drug. new drugs old drugs- new indications, new combinations, new components investigational use of commercially available drugs.

232 views • 20 slides

Chapter 4 Cultural, Legal, & Ethical Considerations

485 views • 20 slides

SphingoGene, Inc. Delaware C-Corporation

Small Molecule Platform for Improving Radiation Treatment of Prostate and other Cancers. SphingoGene, Inc. Delaware C-Corporation. Background on SphingoGene. Founded in 2006 by scientist-entrepreneurs at the Medical University of South Carolina (MUSC)

316 views • 20 slides

Patricia Kerby, MPA Human Subjections Protection Compliance Officer Office of Research Compliance

333 views • 19 slides

Informed Consent

Informed Consent. Basic and Additional Elements. Who must obtain consent?.

366 views • 15 slides

The QA/QI Process Human Research Subjects Protection Human Investigation Committee Tracy Rightmer, JD, CIP Compliance Ma

349 views • 13 slides

2-Topic Imaging Workshop: (1)Standards for Imaging Endpoints in Clinical Trials (2) Manufacturing of PET Radiopharmaceu

2-Topic Imaging Workshop: (1)Standards for Imaging Endpoints in Clinical Trials (2) Manufacturing of PET Radiopharmaceutical Products. Wendy R. Sanhai, Ph.D., M.B.A Senior Scientific Advisor Office of the Commissioner, FDA. Society of Nuclear Medicine Albuquerque, Feb 1, 2009.

272 views • 8 slides