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Displaying ich PowerPoint Presentations



ICH Q9 Quality Risk Management PPT

Presentation Summary : Risk Management ICH Q9 Annex I: Methods & Tools 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/Tools/Q9_Tools_-_overall_notes.ppt

ICH Q9 Principles and Challenges - Food and Drug Administration 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

LEARNING OBJECTIVES - inglasia Pharma Solutions for Quality ... PPT

Presentation Summary : LEARNING OBJECTIVES. Awareness of ICH / EMA / other Stability Guidelines. Understand . minimum requirements for . Routine Stability study . of . marketed products (for

Source : http://inglasia.com/wp-content/uploads/2013/04/020-Post-Approval-Stability-Testing.pptx

Differences in OHRP, FDA and ICH Regulations/Guidelines 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

Guidelines - World Health Organization PPT

Presentation Summary : 1-7.The ICH Q8 “Minimal Approach” to Pharmaceutical Development Satish Mallya January , 2011 Pharmaceutical Development Q8(R2) The aim of pharmaceutical ...

Source : http://apps.who.int/prequal/trainingresources/pq_pres/Training_PQAssessment-2011/presentations/1-7_ICH-Q8.ppt

What Impact can ICH Q8 have on ICH Q6A Decision Trees? 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

Research Informed Consent - MD Anderson 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

Guidelines - World Health Organization 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

ICH Q8 + Q9 - Presentation for IPA-EDQM Workshop PPT

Presentation Summary : Title: ICH Q8 & Q9 - Presentation for IPA-EDQM Workshop Subject: 29.Nov.07 Author: BABU Last modified by: Babu Suri Created Date: 1/25/2007 1:55:36 AM

Source : http://ipapharma.org/events/ppt/K.%20S.%20BABU.ppt

Intracranial Hemorrhage - University of Illinois at Chicago PPT

Presentation Summary : Title: Intracranial Hemorrhage Author: Marc Dorfman, MD, FACEP, MACP Last modified by: FERNE Created Date: 5/26/2000 6:35:20 PM Document presentation format

Source : http://www.uic.edu/com/ferne/pps/acep_dc_0905/ferne_acep_dc_0905_dorfman_ich_path.pps

Guidelines - World Health Organization 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

DETERMINATION OF RELATED SUBSTANCES + IMPURITIES IN DRUGS BY ... PPT

Presentation Summary : determination of related substances & impurities in drugs by ich guide lines by m.paul richards introduction analytical procedures. residual solvents ich guidelines ...

Source : http://memberfiles.freewebs.com/49/71/47557149/documents/RICHIE%20ICH.ppt

International Conference on Harmonization (ICH) and the ... PPT

Presentation Summary : ICH Update: Developments and Future Directions IV Pan American Conference on Drug Regulatory Harmonization Boca Chica, Dominican Republic 2-4 March, 2005

Source : http://www.vpmthane.org/adc/DRA_Presentations/ICH_Review_Gangal.ppt

Company name DEPARTMENT Quality Systems - inglasia Pharma ... PPT

Presentation Summary : The Overview. The Quality System. Quality Systems and Inspections. How ICH Q 10 can and will contribute. How to Set-up a Good Quality System. Recommendations for the ...

Source : http://inglasia.com/wp-content/uploads/2012/04/013-Quality-Systems-ICH-Q101.pptx

DO THE CODES APPLY TO MY RESEARCH? - The Department of Bioethics 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

MISTIE for ICH and IVH - Issam Awad PPT

Presentation Summary : Title: MISTIE for ICH and IVH Author: Issam Awad Last modified by: Issam Awad Created Date: 7/30/2006 8:31:32 PM Document presentation format: On-screen Show

Source : http://www.issamawad.com/powerpoint/ClinicalResearch.ppt

Can Less Really Be More? Source Documentation in Clinical ... PPT

Presentation Summary : Can Less Really Be More? Source Documentation in Clinical Trials Ruth Ann Nylen, PhD The RAN Institute, Inc & David A. Lepay, MD PhD (and Stan Woollen)

Source : http://www.raninstitute.com/PDF_PP_Docs/Can%20Less%20Really%20Be%20More%20ACRP%20April%206,%202005.ppt

Prosthetic Valve; Anticoagulation After ICH PPT

Presentation Summary : Lobar hemorrhage or cerebral amyloidangiopathy - higher risk of anticoagulant related ICH recurrence than thromboembolic events – No anticoagulants.

Source : http://cardiologycmc.in/PPT/Anticoagulation%20after%20ICH-Dr%20Thahsin.pptx

Fraud at Investigator Sites - P. Below Consulting 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

“So You Think You Know GCP ...” - P. Below Consulting PPT

Presentation Summary : “So You Think You Know GCP ...” Professional Development Session S049 Sunday, 15 April 2012 FDA Regulations (21 CFR 312/812) and Guidance (ICH GCP) specify the ...

Source : http://www.pbelow-consulting.com/power_point/so_you_think_know_gcp_AMS_03-2012.ppt

ICH-GCP update - prognosis.org 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

Safety Pharmacology for Oncology Pharmaceuticals at CDER PPT

Presentation Summary : Questions For the Safety Pharmacologists Will ICH S9 change the safety pharmacology package you currently conduct? How do you decide what the package should contain?

Source : http://safetypharmacology.org/SPS_Oncolytics_webinar.ppt

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