ICH GCP

PAREXEL International Clinical Research
PAREXEL International Clinical ResearchPAREXEL International Clinical Research
••
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?
 
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ICH GCP

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PAREXEL International Clinical Research
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ICH GCP

  • 1. Overview of ICH GCP Syed Sarfaraz Uddin e-mail: syed.sarfaraz.uddin@gmail.com
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  • 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:
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  • 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.
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Hinweis der Redaktion

  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.