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Displaying clinical safety data management PowerPoint Presentations



Clinical Practice April 09 - Lex Jansen PPT

Presentation Summary : Interactive Clinical Data Review for Safety Assessment and Trial Operations Management M. O’Connell, PhD Sr. Director, Analytics Spotfire Clinical Practice

Source : http://www.lexjansen.com/phuse/2010/ad/AD04.ppt

PowerPoint Presentation PPT

Presentation Summary : PSUR ICRI,DELHI CLINICAL SAFETY DATA MANAGEMENT: PERIODIC SAFETY UPDATE REPORTS FOR MARKETED DRUGS 1. INTRODUCTION 1.1 Objectives of the guideline To harmonise ...

Source : http://xa.yimg.com/kq/groups/23237093/1756503620/name/psur

Evaluation of Risk with Over-the-Counter Drug Products PPT

Presentation Summary : Postmarketing Risk Assessment of Drug Products Division of Drug Risk Evaluation Office of Drug Safety Center for Drug Evaluation and Research DDRE: Division Mission ...

Source : http://www.fda.gov/ohrms/dockets/ac/03/briefing/3932B1_05_Risk%20Assessment.ppt

Safety Guidance PPT

Presentation Summary : Pre-Marketing Safety Assessment: The Safety Review Guidance Armando Oliva, M.D. Associate Director for Policy Office of New Drugs Reviewer Guidance: Conducting a ...

Source : http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4136s_02_%20Oliva.ppt

PowerPoint Presentation PPT

Presentation Summary : Data Management Anne Tompkins 1/09/2006 Acronyms GCP: Good Clinical Practices CFR: Code of Federal Regulations ICH: International Conference on Harmonisation CRF ...

Source : http://nihtraining.com/cc/ippcr/current/downloads/Tompkins010906.ppt

Risk Management: Practical Implications for Pharmaceutical ... PPT

Presentation Summary : Safety and Risk Management planning activities should begin early in development ... etc. Review of Clinical Trial Safety Data Develop Risk Management Plan ...

Source : http://www.ehcca.com/presentations/pharmaaudio20050411/turner.ppt

Clinical Data QA - Massachusetts Biotechnology PPT

Presentation Summary : Clinical QA Data Audits A GCP Point of View Linda Del Paggio GCP Compliance BioBridges, LLC Agenda Introduction ICH and GCP GCP and Data Integrity Investigator Site ...

Source : http://www.massbio.org/writable/committees/presentations/clinical_qa_data_audits_a_gcp_point_of_view.ppt

Clinical Trial Management + Part 11 Compliance PPT

Presentation Summary : Clinical Trial Management & Part 11 Compliance Ginger Clasby, MS Exec. VP, Business Development gclasby@promedica-intl.com Background What is Good Clinical Practice?

Source : http://www.promedica-intl.com/ppt/OCRA%20Part%2011%20Presentation%20Rev%201.ppt

DUKE CLINICAL RESEARCH INSTITUTE - North Carolina State ... PPT

Presentation Summary : ... Statistics Data management Site management and clinical monitoring Safety ... Leadership Statistics Data Management Safety Desk & CEC IVRS ...

Source : http://www.ncsu.edu/crsc/events/ugw06/presentations/KJA.ppt

Marshaling Data to Improve Patient Safety PPT

Presentation Summary : Marshaling Data to Improve Patient Safety Michelle Mello, JD, PhD Harvard School of Public Health Data-Driven Patient Safety Improvement Major Private Sector Data ...

Source : http://www.aslme.org/media/ppt/mello_091203.ppt

SAE Reconciliation An overview for different studies PPT

Presentation Summary : ... EDC and CDS Support Data Management Clinical Programming ... process can start The data in the Clinical and Safety databases are available ...

Source : http://www.psdm.eu/media/Previous%20events/SAE/17472_20080522_SAE_Recon_AH.ppt

CDISC SDTM Basics - World Wide Web Consortium PPT

Presentation Summary : Document Title: ICH E2B (M) Clinical Safety Data Management: Data Element For Transmission of Individual Case Safety Reports Date: November 16, 2000 Chapter: 2.

Source : http://www.w3.org/wiki/images/7/7c/HCLSIG$$Drug_Safety_and_Efficacy$CDISCs_SDTM_basics.ppt

CLINICAL TRIAL DESIGN - ASGCT - American Society of Gene ... PPT

Presentation Summary : CLINICAL PROTOCOL DEVELOPMENT What’s The Question? ... Monitoring and Management --Data and safety monitoring --Adverse event assessment, ...

Source : http://www.asgct.org/archived_course_materials/training_course/friedman.ppt

Clinical Safety + Effectiveness - University of Texas System PPT

Presentation Summary : Clinical Safety & Effectiveness Reducing TAT in the Clinical Cytogenetics Laboratory- Phase 2 DATE * What do we do in the Clinical Cytogenetics Laboratory?

Source : http://www.utsystem.edu/hea/buildingbridge/files/2011%20presentations%20-%20final/Reducing%20TAT%20in%20The%20Clinical%20Cytogenetics%20Laboratory%20-%20Johnson-Hamiltor,%20Lovshe.ppt

Clinical Trials ( PowerPoint ) - Kriger Research International PPT

Presentation Summary : Kriger Research Group International provides clinical research services for pharmaceutical and biotechnology product development from phase II through phase IV for US ...

Source : http://www.krigerinternational.com/KrigerClinicalTrials-2008.ppt

SAFETY PPT

Presentation Summary : SAFETY In Clinical Laboratories By S.S .Eghbali, MD 29.9.1380 Aspects of clinical Laboratory safety Formal safety program Mandated plans e.g CHP, Blood-borne ...

Source : http://www2.razi-medicallab.ir/Download/safety.ppt

Clinical Trial Management + Part 11 Compliance PPT

Presentation Summary : Title: Clinical Trial Management & Part 11 Compliance Author: Ginger Clasby Last modified by: gclasby Created Date: 2/28/2001 9:58:09 PM Document presentation format

Source : http://www.promedica-intl.com/ppt/OCRA%20Global%20Clinical%20Trials%20Presentation%20-%20PMI.ppt

No Slide Title PPT

Presentation Summary : ... Prospective/retrospective studies of databases on population exposure Clinical safety data management (ADE) : E3: Clinical study reports: ...

Source : http://dr.pierce1.net/PDF/GCP%20Highlights.ppt

Sequential Testing Approaches for Clinical Trials PPT

Presentation Summary : ... Perspective Abstract Overview of Presentation I. Background and General Considerations Risk Assessment and Management Safety Data Collected in Clinical ...

Source : http://www.amstat.org/meetings/fdaworkshop/presentations/2003/PlenarySession4/Timcostigan.ppt

Quality Control Reports - Microbicide Trials Network PPT

Presentation Summary : MTN 003 Data Management Considerations SSP Sections 14, 15 & 17 Presentation Topics Contents of SSP section 14 CRF/label/template supplies Site data management ...

Source : http://www.mtnstopshiv.org/sites/default/files/attachments/Data_Considerations.ppt

Knowledge Update Clinical documentation: from preclinical ... PPT

Presentation Summary : Knowledge Update Clinical documentation: from preclinical studies to drug registration Split, 12 September 2008 Overview of drug development Phases of clinical ...

Source : http://www.docuservicio.com/Files/GMorley%20Fri12_9.00%20Knowledge%20update.ppt

Concepts in Clinical Development Project Management PPT

Presentation Summary : Safety. Clinical. Clinical. Research. Data. Mgmt. Bio Stats. ... The Faces of Clinical Development Project Management. Project Management. Project Leader (Voice to ...

Source : http://ippcr.nihtraining.com/handouts/2012/Breder_02_04_13.pptx

Fraud at Investigator Sites PPT

Presentation Summary : Where the FDA Regulations End and ICH GCP Begins The Differences & Similarities Between the Two Paul Below, CCRA GCP Trainer Medical Research Management, Inc.

Source : http://pbelow-consulting.com/power_point/ich-fda_socra_09-2007.ppt

Analysis Datasets in FDA Submissions 1. A History Lesson PPT

Presentation Summary : ... not focused on overall clinical data management requirements ... Statistical Review of Clinical Trials Data Efficacy and safety Confirmatory ...

Source : http://www.amstat.org/meetings/fdaworkshop/presentations/2005/P07_Christiansen_CDISC.ppt

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