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Displaying ich PowerPoint Presentations



Quality Risk Management ICH Q9 PPT

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

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

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

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

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

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

Guidelines - World Health Organization 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

ICH-GCP + FDA Regulations Differences - University of Louisville PPT

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/advising/humansubjects/ICH%20GCP%20-%20FDA%20Regulations%20Differences_4-20-09.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

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

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

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

STABILITY STUDIES - World Health Organization PPT

Presentation Summary : ... of Interest FDC Fixed-Dose Combination FPP Finished Pharmaceutical Product GMP Good Manufacturing Practices ICH International Conference on Harmonization ...

Source : http://www.who.int/prequal/trainingresources/pq_pres/workshop_China_Jan2006/StabilityStudies.ppt

Regulatory Harmonisation – Industry Perspective PPT

Presentation Summary : Established harmonisation initiatives: ICH. International Conference on Harmonisation. European Union. European Medicines Agency, European Commission and Heads of ...

Source : http://www.iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/2013-Feb-13/Presentations/February%2013%20-%20Plenary%20Keynote%20-%20Honig.pptx

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

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

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

Presentation Summary : ICH GCP Guideline Additional documentation within the text of GCP: ICH GCP 4.1.5: The investigator should maintain a list of appropriately qualified persons to ...

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

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

ICH - a Key Contributor in Developing Tourism 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

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

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