Presentation Summary : Quality Risk Management ICH Q9 Frequently Asked Questions (FAQ) Disclaimer: This presentation includes the authors views on quality risk management theory and practice.
Source : http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Q9_Briefing_Pack/PPT/Q9_FAQ.ppt
Presentation Summary : Title: ICH Q9 Principles and Challenges Author: H G Claycamp Description: Invited talk. Last modified by: Robert King Created Date: 8/1/2005 2:33:51 PM
Source : http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s1_3.ppt
Presentation Summary : International Conference on Harmonization (ICH) Scope. DHHS– human subject research conducted or supported by DHHS or conducted by institutions agreeing to abide by ...
Source : http://hspo.uchc.edu/education_resources/ppt/Differences%20in%20OHRP%20%20FDA%20and%20ICH%20Regulations%20PUBLIC.pptx
Presentation Summary : ICH-GCP & FDA Regulations Differences John D. Burke Director, Human Subjects Protection Program University Of Louisville April 21, 2009 ICH-GCP & FDA Regulations ...
Source : http://louisville.edu/research/humansubjects/ICH%20GCP%20-%20FDA%20Regulations%20Differences_4-20-09.ppt
Presentation Summary : What Impact should ICH Q8 have on ICH Q6A Decision Trees? Ajaz S. Hussain, Ph.D. Deputy Director, OPS/CDER/FDA Outline An overview of ICH Q6A dissolution decision ...
Source : http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4187S1_10_Hussain.ppt
Presentation Summary : ICH Process Q8, Q9, Q10 WHO Workshop, October 2007 Sultan Ghani, Director Bureau of Pharmaceutical Sciences Therapeutic Products Directorate, Health Canada
Source : http://www.who.int/prequal/trainingresources/pq_pres/Tallinn-Oct07/Regulatory_aspectsDev_en.ppt
Presentation Summary : Title: ICH - a Key Contributor in Developing Tourism Author: user Last modified by: leena Created Date: 2/26/2013 10:16:53 AM Document presentation format
Source : http://www.ichngoforum.org/wp-content/uploads/Ananya-Bhattacharya.ppt
Presentation Summary : Title: DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES Author: YNREDDY Last modified by: YNREDDY Created Date: 6/21/2009 11:30:31 AM
Source : http://memberfiles.freewebs.com/49/71/47557149/documents/RICHIE%20ICH.ppt
Presentation Summary : Impact of the CTD The ICH CTD represents one of the most ambitious and successful international harmonization activities undertaken It will significantly reduce ...
Source : http://apps.who.int/prequal/trainingresources/pq_pres/Tallinn-Oct07/Dossier_structure_en.ppt
Presentation Summary : DO THE CODES APPLY TO MY RESEARCH? BELMONT CIOMS Nuremberg HELSINKI ICH/GCP and FDA 45CFR46 Common Rule Codes/guidelines: Research Ethics The Nuremberg Code The ...
Source : http://www.bioethics.nih.gov/slides04/gradycodes.ppt
Presentation Summary : Arial Wingdings Arial Narrow Calibri Times New Roman Old English Text MT VisID 1_VisID 2-4 ICH Quality Guidances: an ...
Source : http://apps.who.int/prequal/trainingresources/pq_pres/4_PQ_AssessmentTraining/2-4%20ICH%20Overview.ppt
Presentation Summary : Title: ICH-GCP update Author: Stephanie Izzard Last modified by: kbaillie Created Date: 3/25/2003 9:49:08 AM Document presentation format: On-screen Show
Source : http://prognosis.org/GenISIS_documents/GenISIS_GCP_v1.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
Presentation Summary : ICH GCP E6 4.8 – …the informed consent should be signed and personally dated by the subject or legally authorized representative. ...
Source : http://www.mdanderson.org/education-and-research/resources-for-professionals/clinical-tools-and-resources/ccop-research-base/multimedia-resources-and-downloads/ccop-audit-workshop-informed-consent-for-handout--kristin--2.12.09.ppt
Presentation Summary : Different subset analyses are required by HAs(assumes Phase III participation. Science is not the only driver behind non-ICH clinical requirements.
Source : http://www.iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/2013-Feb-13/Presentations/February%2013%20-%20Plenary%20Keynote%20-%20Honig.pptx
Presentation Summary : TOWARDS ICH HARMONISATION History of the ICH Rapid increase in laws, regulations and guidelines for reporting & evaluating data on safety, quality & efficacy ...
Source : http://www.imsa.org.za/download/policy_and_reports_medicines/ICH_0104.ppt
Presentation Summary : Fundamentals of ICH and GCP Marybeth Devine BSRT, CNMT Sr. Clinical Program Manager Lantheus Medical Imaging So you are going to run a clinical trial…
Source : http://www.snm.org/docs/CTN/MWM10/DEVINE_SNMMidWinter_CTN_2Feb10_FundamentalsOfICHandGCP.ppt
Presentation Summary : ICH GCP Guideline Protocol requirements for data recording 6.4.9 The identification of any data to be recorded directly on the CRF’s (i.e., ...
Source : http://www.raninstitute.com/PDF_PP_Docs/Can%20Less%20Really%20Be%20More%20ACRP%20April%206,%202005.ppt
Presentation Summary : Tool: Training Presentation: Investigator Responsibilities and Good Clinical Practice (GCP) Based on ICH . E6. GCP Guidance (Sections1.24 & 6) and 45
Source : http://www.nidcr.nih.gov/NR/rdonlyres/A80BF3F8-C860-4CB7-B584-217C0F3F21F6/0/Investigator_Responsibilities_ICHGCP_TSS_approved_v20_20130326.pptx
Presentation Summary : ICH is there as a constant reminder of what are the implications of Non GCP Next slide Started in the US following a number of accidents about purity of drugs.
Source : http://www.itsqa.com/acdm.ppt