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ICH guideline E11A on pediatric extrapolation

Published by

Paediatric Investigation Plan Paediatric Submission

The guidance outlines the main steps to take in preparation for submission and a list of documents required for the main1 types of paediatric submissions.

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UNESCO. International Declaration on Human Genetic Data, 2003.

Published by Unesco

UNESCO Genetic Data

The purpose of the Declaration is to ensure the respect of human dignity and protection ofhuman rights and fundamental freedoms in the collection, processing, use and storage ofhuman genetic data, in keeping with the requirements of equality, justice and solidarity

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Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

Published by United Nations

Genetic Resources Nagoya Protocol

The Protocol provides
a strong basis for greater legal certainty and transparency for both providers
and users of genetic resources. It also promotes the use of genetic resources and associated traditional knowledge, strengthens the opportunities for fair and equitable sharing of benefits from their use.

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World Health Organization. HUMAN GENOME EDITING: RECOMMENDATIONS. 2021

Published by World Heath Organization

Genome Editing WHO World Health Organization

The WHO provide the first global recommendations to help establish human genome editing as a tool for public health, with an emphasis on safety, effectiveness and ethics.

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Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2)

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Regulatory Authorities Internatonal Council for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.

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Clinical Trials Facilitation and Coordination Group Guidance document for sponsors for a Voluntary Har

Published by EMA

Clinical Trials

The main objectives of the assessment of the CT are to ensure the quality of the IMP and the safety of the trial subjects.

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CIOMS Cumulative Pharmacovigilance GLOSSARY. Version 1.1

Published by CIOMS

Pharmacovigilance CIOMS

This document makes a list of Glossary about Cumulative Pharmacovigilance of : Council for International
Organizations of Medical Sciences (CIOMS)

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Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans. 2016.

Published by Council for International Organizations of Medical Sciences (CIOMS)

Clinical Trials Observational Research Biobanking Epidemiological Studies

The Working Group decided to broaden the scope of the 2002 Guidelines from “biomedical research”
to “health-related research”. The Working Group considered biomedical research too narrow since that
term would not cover research with health-related data.

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World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects

Published by JAMA

Research Ethics Human Subjects

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

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ICH HARMONISED GUIDELINE. GENERAL CONSIDERATIONS FOR Clinical Studies. E8(R1)

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Rights Clinical Study Data Sources

This document provides guidance on the clinical development lifecycle, including designing quality into Clinical Studies, considering the broad range of clinical study designs and data sources used.

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ICH guideline E11A on pediatric extrapolation

UNESCO. International Declaration on Human Genetic Data, 2003.

Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

World Health Organization. HUMAN GENOME EDITING: RECOMMENDATIONS. 2021

Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2)

Clinical Trials Facilitation and Coordination Group Guidance document for sponsors for a Voluntary Har

CIOMS Cumulative Pharmacovigilance GLOSSARY. Version 1.1

Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans. 2016.

World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects

ICH HARMONISED GUIDELINE. GENERAL CONSIDERATIONS FOR Clinical Studies. E8(R1)

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