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Documents Compliance Considerations in Pharmaceutical Product Development Compliance Considerations in...

Slide 1Compliance Considerations in Pharmaceutical Product Development Compliance Considerations in Pharmaceutical Product Development John C. (Jack) Garvey, Esq. THE WEINBERG…

Documents FDA Compliance Actions Against IRBs and Clinical Investigators Paul W. Goebel, Jr., CIP Vice...

Slide 1FDA Compliance Actions Against IRBs and Clinical Investigators Paul W. Goebel, Jr., CIP Vice President [email protected] Chesapeake Research Review, Inc. 410-884-2900…

Documents Understanding Our HRPP and Your Role in the Accreditation Process.

Slide 1Understanding Our HRPP and Your Role in the Accreditation Process Slide 2 Introduction Eugene Oddone, MD, Vice Dean for Research Slide 3 3 What is AAHRPP? Association…

Documents FDA Final Rule & Revised NCI Guidelines for Expedited Reporting of Adverse Events S. Percy Ivy, MD.....

Slide 1FDA Final Rule & Revised NCI Guidelines for Expedited Reporting of Adverse Events S. Percy Ivy, MD Associate Chief, Senior Investigator Investigational Drug Branch,…

Documents Ann Johnson IRB Administrator, IRB Member. Objectives 1. Identify the components necessary for...

Slide 1Ann Johnson IRB Administrator, IRB Member Slide 2 Objectives 1. Identify the components necessary for management and oversight of tissue repositories used for research.…

Documents NIH RESEARCH CONTRACTS Rosemary M. Hamill Procurement Analyst Division of Acquisition Policy and...

Slide 1NIH RESEARCH CONTRACTS Rosemary M. Hamill Procurement Analyst Division of Acquisition Policy and Evaluation Office of Acquisition Management and Policy NIH, DHHS Slide…

Documents NIH RESEARCH CONTRACTS Rosemary M. Hamill Procurement Analyst Office of Acquisitions National Cancer...

Slide 1NIH RESEARCH CONTRACTS Rosemary M. Hamill Procurement Analyst Office of Acquisitions National Cancer Institute NIH/DHHS Slide 2 NIH Research Contracts What are they?…

Documents Biosafety in Biomedical Laboratories June 2, 2009 Marshall University Summer Students/Recent Hires.....

Slide 1Biosafety in Biomedical Laboratories June 2, 2009 Marshall University Summer Students/Recent Hires Please complete the sign in sheet Slide 2 Major Safety Concerns…

Documents “Minor Change” What Exactly Does That Mean? Presentation to SACHRP by Gary L. Chadwick, PharmD,....

Slide 1“Minor Change” What Exactly Does That Mean? Presentation to SACHRP by Gary L. Chadwick, PharmD, MPH, CIP Professor and Associate Provost University of Rochester…

Documents Centre for Investigational New Product National Pharmaceutical Control Bureau, MOH.

Slide 1Centre for Investigational New Product National Pharmaceutical Control Bureau, MOH Slide 2 OUTLINE Introduction Guidelines and Legal Requirements Application Process…