'Clinical investigator' presentation slideshows

FDA Regulatory Perspective: Data Integrity

FDA Regulatory Perspective: Data Integrity. Steve Wilson, Dr.P.H., CAPT USPHS Deputy Director, Division of Biometrics II, CDER/FDA NIH Roadmap Program Feasibility of Integrating & Expanding Clinical Research Networks 4th Steering Committee Meeting Friday, May 12, 2006

1.33k views • 67 slides

Good Clinical Practice - GCP Outline of Topics

Pediatric Clinical Investigator Training GCP: Tips on Clinical Trial Conduct and Preparing for FDA Inspection Susan Leibenhaut, M.D. Office of Scientific Investigations (OSI) CDER/FDA February 28, 2019. Good Clinical Practice - GCP Outline of Topics.

661 views • 65 slides

Safety Workshop: Part II Expedited Reporting & Assessment

Safety Workshop: Part II Expedited Reporting & Assessment . Olu Ogunyankin, MD DAIDS Regulatory Support Center ( RSC) Durban, South Africa May 13, 2011. Objectives. About Manual v2.0 Definitions Assessment of Adverse Events Expedited Reporting Processes.

1.31k views • 63 slides

Current Topics in Clinical Research

751 views • 59 slides

The IND Process

1.06k views • 55 slides

Judit Milstein Chief, Project Management Staff

CLINICAL INVESTIGATOR How to put together an application?. Judit Milstein Chief, Project Management Staff Division of Special Pathogen and Transplant Products Center for Drug Evaluation and Research Judit.milstein@fda.hhs.gov 301-796-0763. Class outline. Definitions

609 views • 49 slides

Everyday Preparedness for the Challenges of FDA-Regulated Research

572 views • 49 slides

The Role of the Investigator in Clinical Research

The Role of the Investigator in Clinical Research. Pat Beers Block Good Clinical Practice Program February 27, 2004. Clinical Investigators. As THE point of contact with study subjects, the Investigator is a critical control point

586 views • 36 slides

How to Survive an FDA Inspection

How to Survive an FDA Inspection. Patricia S. Kerby, MPA Office of Human Subjects Protection January 7, 2009. Why are Inspections Done?. Protect the rights and welfare of human subjects Assure quality and integrity of data Ensure compliance with regulatory requirements.

384 views • 24 slides

How to Survive an FDA Inspection

How to Survive an FDA Inspection. Patricia S. Kerby, MPA Office of Human Subjects Protection January 7, 2009. Why are Inspections Done?. Protect the rights and welfare of human subjects Assure quality and integrity of data Ensure compliance with regulatory requirements.

374 views • 24 slides

Ruth Lapid-Gortzak MD PhD 1,2 , Jan Willem van der Linden BOpt 2 , and

Comparison of a hydrophilic and a hydrophobic apodized diffractive multifocal IOL. Ruth Lapid-Gortzak MD PhD 1,2 , Jan Willem van der Linden BOpt 2 , and Ivanka J. van der Meulen MD 1,2 1 Department of Ophthalmology, Academic Medical Center, University of Amsterdam, the Netherlands

348 views • 6 slides

Experience with a new 4 loop haptics apodized diffractive hydrophilic multifocal IOL

Experience with a new 4 loop haptics apodized diffractive hydrophilic multifocal IOL. Ruth Lapid-Gortzak MD PhD 1,2 Ivanka van der Meulen MD 1,2 Jan Willem van der Linden Boptom . 2 1. AMC, University of Amsterdam 2. Retina Total Eye Care, Driebergen

324 views • 6 slides

James Bussel: Disclosures

James Bussel: Disclosures. Professor of Pedatrics, Medicine and OB-GYN at Weill Cornell in New York My family owns stock in Amgen and Glaxo Smith Kline (in trusts not under my control)

113 views • 4 slides