FDA s Clinical Investigator Course

Aug 25, 2012

320 likes | 507 Views

Safety assessment in Clinical Trials and Beyond. Yuliya Yasinskaya, MDNovember 8, 2011Medical OfficerDivision of Anti-infective ProductsCenter for Drug Evaluation and Research. . Outline. IntroductionSources of safety informationIs your patient right for the trial?Safety monitoring/ AE asce

Share Presentation

Embed Code

Link

tuwa

Download Presentation

FDA s Clinical Investigator Course

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

1. Cosponsored by FDA�s Office of Critical Path Programs (OCPP) and The Clinical Trials Transformation Initiative (CTTI)

Investigator Responsibilities Regulation and Clinical Trials

Outline. Historical Perspective on FDA regulation of clinical trialsInvestigator responsibilities Case examples and suggestions. 50th Anniversary. Dr. Frances Kelsey honored September 15, 2010. Thalidomide Tragedy. Historical Perspective. 1961-1962: Thalidomide tragedyDrug sold to public as a hypnotic in Europe, but investigational in U.S.

1.1k views • 38 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

FDA Oversight of Cell Therapy Clinical Trials

FDA Oversight of Cell Therapy Clinical Trials. Celia Witten, Ph.D., M.D. Office Director, Office of Cellular, Tissue, and Gene Therapies CBER/FDA ISSCR/CIRM/ISCT Workshop June 15, 2010 San Francisco, California. FDA Organization . Office of the Commissioner Office of Combination Products

855 views • 29 slides

FDA s Clinical Investigator Course

Medical Device Clinical Trials: An FDA Perspective. Bram Zuckerman, MD, FACCDirector Division of Cardiovascular Devices CDRH. Today's Topics. 1. Introduction2. Premarket Device Trials3. Off-Label Use. What does the U.S. medical device industry look like? . Smallest Firms. Employees Per Fir

637 views • 34 slides

FDA s Clinical Investigator Course

Background. BS Chemistry, MS Chemical Engineering10 years - Consumer Goods IndustryConsultant - Change Management in Mfg. and UtilitiesDiagnosed Stage IIIB breast cancer in 1990Phase 2 clinical trial participantEVP - National Breast Cancer CoalitionWorked for Director, National Cancer Institut

300 views • 14 slides

FDA Pharmacogenetic Labels A Clinical Perspective

FDA Pharmacogenetic Labels A Clinical Perspective . David A Flockhart MD, PhD Indiana University School of Medicine . Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science FDA, CDER November 14 th , 2005. The Purpose of Pharmacogenomics .

352 views • 21 slides

Electroretinography: The FDA s Viewpoint

2. Disclaimer. The opinions and assertions expressed in this presentation are the private views of the speaker. No endorsement by the Food and Drug Administration is intended or should be inferred.The speaker has no financial interest or other relationship with the manufacturer of any commercial

700 views • 32 slides

Hosting an FDA Inspection: A Field Investigator ’ s Perspective

Hosting an FDA Inspection: A Field Investigator ’ s Perspective. Presented by Mihaly S. Ligmond Consumer Safety Officer US Food and Drug Administration, Division of Domestic Field Investigations PRCSQA/ORCANW Meeting November 2010. Objective.

848 views • 19 slides

FDA Inspections of Investigator Sites

FDA Inspections of Investigator Sites . Paul Below Clinical Research Consultant P. Below Consulting, Inc. Learning Objectives. Describe the FDA’s Bioresearch Monitoring Program (BIMO) Define the BIMO inspection activities during an investigator inspection

489 views • 22 slides

Perspectives from a Clinical Investigator

Perspectives from a Clinical Investigator. Dr Darren Hargrave Consultant Paediatric Oncologist in Neuro -oncology & Experimental Therapeutics. Outline. Current paediatric unmet needs. Role of paediatric cancer networks & experts.

603 views • 44 slides

US FDA Inspection at Clinical Investigator Site Sharing of Lessons Learned

US FDA Inspection at Clinical Investigator Site Sharing of Lessons Learned Presenter: Nattharat Laemlukvorakul CPO Development Quality Manager Date: 01-Mar-13. Pre-announced Inspection – Preliminary Info & Assistance.

577 views • 17 slides

US FDA Foreign Inspection s; Clinical Investigators

US FDA Foreign Inspection s; Clinical Investigators. At: Mahidol University Date: 1 MAR 2013 By: Pravich Tanyasittisuntorn, MD, EMBA, MSc. in Pharm Med. Overview. Organizations Involved. Center headquarters :

1.11k views • 86 slides

FDA Approvals, IND, IDE and Clinical Trials

FDA Approvals, IND, IDE and Clinical Trials. March 16, 2011 Gerberding Hall 142, University of Washington. Speakers. Lynn Rose, Research Associate Professor, Pediatrics; Director, Regulatory and Clinical Affairs, Seattle Children’s Research Institute

875 views • 52 slides

Investigator Responsibilities and Good Clinical Practice (GCP )

NIDCR. CROMS. National Institute of Dental and Craniofacial Research National Institutes of Health. C linical Research Operations and Management Support Rho, Inc., Federal Division. Investigator Responsibilities and Good Clinical Practice (GCP ).

939 views • 46 slides

FDA’s Clinical Investigator Course

FDA’s Clinical Investigator Course. A Patient Advocate’s Perspective on Clinical Trials Jane Reese-Coulbourne Executive Director, Reagan-Udall Foundation for the FDA. Background. BS Chemistry, MS Chemical Engineering 10 years - Consumer Goods Industry

361 views • 12 slides

FDA International Food Investigator

FDA International Food Investigator. LCDR Jane C. Chen, RD, BS, MBA, DHSc. US PHS Conference June 21 st , 2011. Overview. FDA International Programs Dedicated Food Cadre Questions. FDA International Program. FDA has conducted international inspections since 1955

547 views • 21 slides

Investigator-Initiated Clinical Research

Investigator-Initiated Clinical Research. Planning, Developing, Conducting, Managing, and Succeeding Wm. Hirschhorn, M.S. Director, OCT & RQI and Adj. Prof of Regulatory Affairs Office of Clinical Trials & Research Quality Improvement 2-5245 2-3106. Objectives. To begin to be able to …

994 views • 21 slides

Investigator Responsibilities in Clinical Research

Investigator Responsibilities in Clinical Research. Melissa Adde Director, Clinical Trials Office, INCTR. www.inctr.org. Topics to be Discussed. Overview of Clinical Trials Good Clinical Practice The “Research Team” The Role and Responsibilities of the Principal Investigator.

747 views • 40 slides

Private investigator course Ontario

At no time in our cutting-edge history have more demands been positioned upon the investigators. Communities are extremely concerned about crime and they are traumatic that investigating corporations "do something about it.

41 views • 3 slides

Investigator-Initiated Clinical Research

247 views • 21 slides

Clinical Research Investigator – The Specialists

a blasting field of study and business

52 views • 3 slides

More Related