SlideShare a Scribd company logo
1 of 48
Overview   of  ICH GCP Syed Sarfaraz Uddin e-mail: syed.sarfaraz.uddin@gmail.com
What is ICH? ,[object Object]
How did it evolve? ,[object Object],[object Object],[object Object],[object Object],[object Object]
History ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
When did it begin?   ,[object Object],[object Object],[object Object],Industry Academia Ministry of health
ICH parties ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Key objective ,[object Object]
The result? ,[object Object],[object Object],[object Object],[object Object]
ICH Guidelines: examples ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The ICH Story Through the development of science-based, international guidelines and standards How: Reduce unnecessary duplication and thereby contribute to the efficiency of  drug development and registration for  new  pharmaceuticals Why: Regulatory authorities and research-based industry of the EU, US and Japan; WHO, EFTA and Canada observers Who:
What is GCP? ,[object Object]
Why is it needed?   ,[object Object],[object Object]
The ICH GCP guideline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ICH GCP guideline ,[object Object]
ICH GCP guideline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ICH GCP guideline ,[object Object],[object Object],[object Object],[object Object],[object Object]
Principles of ICH GCP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Principles of ICH GCP ,[object Object],[object Object],[object Object],[object Object],[object Object]
Principles of ICH GCP ,[object Object],[object Object],[object Object],[object Object],[object Object]
Principles of ICH GCP ,[object Object],[object Object],[object Object]
Principles of ICH GCP ,[object Object],[object Object],[object Object]
Principles of ICH GCP ,[object Object],[object Object]
Concerns about ICH ,[object Object],[object Object],[object Object]
ICH vs. non-ICH ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Indian GCP guidelines   ,[object Object],[object Object],[object Object]
Issues in Developing Countries ,[object Object],[object Object],[object Object],[object Object]
ROLE OF GCP ? ,[object Object],[object Object],[object Object]
INTERNATIONAL ETHICAL STANDARDS ,[object Object],[object Object],[object Object]
Fundamental Ethical Principles Guiding Protection Of Human Subjects In Biomedical Research ,[object Object],[object Object],[object Object]
PRINCIPLES BEHIND GCP ,[object Object],[object Object],[object Object]
ETHICAL REVIEW SHOULD DEFINE JUSTIFIABLE BOUNDARIES BETWEEN THE RIGHTS OF THE SUBJECT AND THE BENEFITS THAT MIGHT ACCRUE TO SOCIETY THROUGH SCIENTIFIC INFORMATION DEVELOPED IN CLINICAL TRIALS. Regulations have been established internationally, to ensure ethical & scientific conduct of trials
GOALS OF INTERNATIONAL HARMONIZATION OF REGULATORY REQUIREMENTS ,[object Object],[object Object],[object Object],[object Object],[object Object]
STAKEHOLDERS & THEIR RELATIONSHIPS MONITOR DATA SUBJECT REGULATORY AUTHORITY SPONSOR ETHICS COMMITTEE INVESTIGATOR
ROLE OF ETHICS COMMITTEES ,[object Object],[object Object],[object Object],[object Object],[object Object]
Protection of Human Subjects Prior To Study Start ,[object Object],[object Object],[object Object],[object Object],[object Object]
Protection of Human Subjects   During the study ,[object Object],[object Object],[object Object]
RESPONSIBILITIES OF THE INVESTIGATOR ,[object Object],[object Object],[object Object],[object Object],[object Object]
RESPONSIBILITIES OF THE SPONSOR ,[object Object],[object Object],[object Object]
MEDICAL CARE OF TRIAL SUBJECTS ,[object Object],[object Object]
Protection of Human Subjects Informed Consent ,[object Object],[object Object],[object Object],[object Object],[object Object]
Study Documentation Before the study starts ,[object Object],[object Object],[object Object]
Study Documentation During the study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Medical Records ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Study Documentation After the study ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],INVESTIGATIONAL PRODUCT
MONITORING ,[object Object],[object Object],[object Object],[object Object]
Questions?
 

More Related Content

What's hot

Roles and Responsibilities of sponsor in conducting clinical trials as per GC...
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Roles and Responsibilities of sponsor in conducting clinical trials as per GC...
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
 
Documentation clinical trial
Documentation clinical trialDocumentation clinical trial
Documentation clinical trialankit sharma
 
Clinical trial study team
Clinical trial study teamClinical trial study team
Clinical trial study teamBharatPatil42
 
Preparation of Clinical Trial Protocol of India.
Preparation of Clinical Trial Protocol of India.Preparation of Clinical Trial Protocol of India.
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
 
Indian gcp ppt cr by ann
Indian gcp ppt cr by annIndian gcp ppt cr by ann
Indian gcp ppt cr by annAnjali Rarichan
 
Essential Documents of Clinical Trials_2
Essential Documents of Clinical Trials_2Essential Documents of Clinical Trials_2
Essential Documents of Clinical Trials_2heba rashed
 
Clinical Studies -- Overview of FDA Regulation
Clinical Studies -- Overview of FDA RegulationClinical Studies -- Overview of FDA Regulation
Clinical Studies -- Overview of FDA RegulationMichael Swit
 
Role and responsibility of principal investigator
Role and responsibility of principal investigatorRole and responsibility of principal investigator
Role and responsibility of principal investigatorSurabhi Vaghela Kirtane
 
ICH GCP guidelines
ICH GCP guidelinesICH GCP guidelines
ICH GCP guidelinesrx_sonali
 
Good clinical practices(GCP)
Good clinical practices(GCP)Good clinical practices(GCP)
Good clinical practices(GCP)Fardan Qadeer
 
New drugs and Clinical Trials Rule in india 2019
New drugs and Clinical Trials Rule in india 2019New drugs and Clinical Trials Rule in india 2019
New drugs and Clinical Trials Rule in india 2019Arya V Devi
 
Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
 
SAE REPORTING TIMELINE AND COMPENSATION 2019
SAE REPORTING TIMELINE AND COMPENSATION 2019SAE REPORTING TIMELINE AND COMPENSATION 2019
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
 
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
 
Essential documents
Essential documentsEssential documents
Essential documentsRajeev Sahai
 
Differences between indian gcp and ich-gcp
Differences between indian gcp and ich-gcpDifferences between indian gcp and ich-gcp
Differences between indian gcp and ich-gcpUpendra Agarwal
 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)Turacoz Skill Development Program
 

What's hot (20)

Roles and Responsibilities of sponsor in conducting clinical trials as per GC...
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Roles and Responsibilities of sponsor in conducting clinical trials as per GC...
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...
 
Good Clinical Practice
Good Clinical PracticeGood Clinical Practice
Good Clinical Practice
 
Documentation clinical trial
Documentation clinical trialDocumentation clinical trial
Documentation clinical trial
 
Clinical trial study team
Clinical trial study teamClinical trial study team
Clinical trial study team
 
Preparation of Clinical Trial Protocol of India.
Preparation of Clinical Trial Protocol of India.Preparation of Clinical Trial Protocol of India.
Preparation of Clinical Trial Protocol of India.
 
Indian gcp ppt cr by ann
Indian gcp ppt cr by annIndian gcp ppt cr by ann
Indian gcp ppt cr by ann
 
Essential Documents of Clinical Trials_2
Essential Documents of Clinical Trials_2Essential Documents of Clinical Trials_2
Essential Documents of Clinical Trials_2
 
Clinical Studies -- Overview of FDA Regulation
Clinical Studies -- Overview of FDA RegulationClinical Studies -- Overview of FDA Regulation
Clinical Studies -- Overview of FDA Regulation
 
Role and responsibility of principal investigator
Role and responsibility of principal investigatorRole and responsibility of principal investigator
Role and responsibility of principal investigator
 
ICH GCP guidelines
ICH GCP guidelinesICH GCP guidelines
ICH GCP guidelines
 
Good clinical practices(GCP)
Good clinical practices(GCP)Good clinical practices(GCP)
Good clinical practices(GCP)
 
New drugs and Clinical Trials Rule in india 2019
New drugs and Clinical Trials Rule in india 2019New drugs and Clinical Trials Rule in india 2019
New drugs and Clinical Trials Rule in india 2019
 
ICH-GCP Introduction
ICH-GCP IntroductionICH-GCP Introduction
ICH-GCP Introduction
 
Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...
 
Ich e6(r1)
Ich e6(r1)Ich e6(r1)
Ich e6(r1)
 
SAE REPORTING TIMELINE AND COMPENSATION 2019
SAE REPORTING TIMELINE AND COMPENSATION 2019SAE REPORTING TIMELINE AND COMPENSATION 2019
SAE REPORTING TIMELINE AND COMPENSATION 2019
 
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
 
Essential documents
Essential documentsEssential documents
Essential documents
 
Differences between indian gcp and ich-gcp
Differences between indian gcp and ich-gcpDifferences between indian gcp and ich-gcp
Differences between indian gcp and ich-gcp
 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
 

Similar to ICH GCP

GCP and EC Training (2).ppt
GCP and EC Training (2).pptGCP and EC Training (2).ppt
GCP and EC Training (2).pptgayathrivd1
 
ICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxyogesh532361
 
OVERVIEW OF ICH-GCP GUIDELINES
OVERVIEW OF ICH-GCP GUIDELINESOVERVIEW OF ICH-GCP GUIDELINES
OVERVIEW OF ICH-GCP GUIDELINESadityamalan2
 
Good clinical practise ppt
Good clinical       practise pptGood clinical       practise ppt
Good clinical practise pptkabir ahmad
 
S1 KAVANA BB MBAT-Goos clinical Pratice.pptx
S1 KAVANA BB MBAT-Goos clinical Pratice.pptxS1 KAVANA BB MBAT-Goos clinical Pratice.pptx
S1 KAVANA BB MBAT-Goos clinical Pratice.pptxVenkatesan R - 6369851191
 
Good clinical practice by vijay
Good clinical practice by vijayGood clinical practice by vijay
Good clinical practice by vijayvijaypv
 
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIALICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIALMOHAMMED FAHEEM KHAN
 
Siobhan gaynor patientclinicalresearchtalkdec15
Siobhan gaynor   patientclinicalresearchtalkdec15Siobhan gaynor   patientclinicalresearchtalkdec15
Siobhan gaynor patientclinicalresearchtalkdec15ipposi
 
C userstrishit.banerjee desktopamritaclinical research introduction phases a...
C userstrishit.banerjee desktopamritaclinical research  introduction phases a...C userstrishit.banerjee desktopamritaclinical research  introduction phases a...
C userstrishit.banerjee desktopamritaclinical research introduction phases a...AMRITABHATTACHARYA14
 
What is clinical research? Why to do it?
What is clinical research? Why to do it?What is clinical research? Why to do it?
What is clinical research? Why to do it?vsharma1087
 
GCP-Good Clinical Practice
GCP-Good Clinical PracticeGCP-Good Clinical Practice
GCP-Good Clinical PracticeANANT NAG
 

Similar to ICH GCP (20)

GCP and EC Training (2).ppt
GCP and EC Training (2).pptGCP and EC Training (2).ppt
GCP and EC Training (2).ppt
 
ICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptx
 
OVERVIEW OF ICH-GCP GUIDELINES
OVERVIEW OF ICH-GCP GUIDELINESOVERVIEW OF ICH-GCP GUIDELINES
OVERVIEW OF ICH-GCP GUIDELINES
 
ICH-GCP.pptx
ICH-GCP.pptxICH-GCP.pptx
ICH-GCP.pptx
 
Good clinical practise ppt
Good clinical       practise pptGood clinical       practise ppt
Good clinical practise ppt
 
ICH-GCP Guidelines
ICH-GCP GuidelinesICH-GCP Guidelines
ICH-GCP Guidelines
 
S1 KAVANA BB MBAT-Goos clinical Pratice.pptx
S1 KAVANA BB MBAT-Goos clinical Pratice.pptxS1 KAVANA BB MBAT-Goos clinical Pratice.pptx
S1 KAVANA BB MBAT-Goos clinical Pratice.pptx
 
Good clinical practice by vijay
Good clinical practice by vijayGood clinical practice by vijay
Good clinical practice by vijay
 
ICH GOOD CLINICAL PRACTICE
ICH GOOD CLINICAL PRACTICEICH GOOD CLINICAL PRACTICE
ICH GOOD CLINICAL PRACTICE
 
ICH GCP.ppt
ICH GCP.pptICH GCP.ppt
ICH GCP.ppt
 
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIALICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
 
Gcp 2013
Gcp 2013Gcp 2013
Gcp 2013
 
GCP For M.Pharm
GCP For M.PharmGCP For M.Pharm
GCP For M.Pharm
 
Siobhan gaynor patientclinicalresearchtalkdec15
Siobhan gaynor   patientclinicalresearchtalkdec15Siobhan gaynor   patientclinicalresearchtalkdec15
Siobhan gaynor patientclinicalresearchtalkdec15
 
GCP guidelines
GCP guidelines GCP guidelines
GCP guidelines
 
C userstrishit.banerjee desktopamritaclinical research introduction phases a...
C userstrishit.banerjee desktopamritaclinical research  introduction phases a...C userstrishit.banerjee desktopamritaclinical research  introduction phases a...
C userstrishit.banerjee desktopamritaclinical research introduction phases a...
 
GCP ppdf
GCP ppdfGCP ppdf
GCP ppdf
 
What is clinical research? Why to do it?
What is clinical research? Why to do it?What is clinical research? Why to do it?
What is clinical research? Why to do it?
 
GCP-Good Clinical Practice
GCP-Good Clinical PracticeGCP-Good Clinical Practice
GCP-Good Clinical Practice
 
Gcp guidelines
Gcp guidelinesGcp guidelines
Gcp guidelines
 

ICH GCP

  • 1. Overview of ICH GCP Syed Sarfaraz Uddin e-mail: syed.sarfaraz.uddin@gmail.com
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10. The ICH Story Through the development of science-based, international guidelines and standards How: Reduce unnecessary duplication and thereby contribute to the efficiency of drug development and registration for new pharmaceuticals Why: Regulatory authorities and research-based industry of the EU, US and Japan; WHO, EFTA and Canada observers Who:
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31. ETHICAL REVIEW SHOULD DEFINE JUSTIFIABLE BOUNDARIES BETWEEN THE RIGHTS OF THE SUBJECT AND THE BENEFITS THAT MIGHT ACCRUE TO SOCIETY THROUGH SCIENTIFIC INFORMATION DEVELOPED IN CLINICAL TRIALS. Regulations have been established internationally, to ensure ethical & scientific conduct of trials
  • 32.
  • 33. STAKEHOLDERS & THEIR RELATIONSHIPS MONITOR DATA SUBJECT REGULATORY AUTHORITY SPONSOR ETHICS COMMITTEE INVESTIGATOR
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41.
  • 42.
  • 43.
  • 44.
  • 45.
  • 46.
  • 48.  

Editor's Notes

  1. Helsinki declaration was adopted by World Medical Assembly in 1964, amended in Tokyo in 1975, in Venice in 1983 and subsequently in Hong Kong in 1989. The most important principle being “Interests of the subject must always prevail over the interests of science and society.” However, this declaration does not necessitate informed consent for therapeutic trials and only requires documentation of reasons for not obtaining the same. The physician is obliged to preserve the accuracy of the results. Thus GCP ensures the credibility of the data.
  2. Most of the current requirements of ethical protection are as a result of reaction by the public, scientific community and politicians in response to reports of abuse of trial subjects during 1960’s and 70’s.