ICH Working Groups

E555147

ICH Working Groups are expert committees within the International Council for Harmonisation that develop and revise harmonized technical guidelines for the safety, quality, and efficacy of pharmaceuticals.

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ICH Working Groups canonical 1

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Predicate Object
instanceOf ICH body
expert committee
technical working group
coordinatedBy ICH Secretariat NERFINISHED
country International
develops ICH E-series guidelines
ICH M-series guidelines
ICH Q-series guidelines
ICH S-series guidelines
training materials for guideline implementation
field biostatistics
clinical research
drug development
nonclinical safety assessment
pharmaceutical regulation
pharmacovigilance
quality assurance
regulatory science
followsProcess ICH guideline 5-step process
geographicScope regions of ICH regulatory members and observers
hasMember academic expert
observer organisation expert
pharmaceutical industry expert
regulatory authority expert
hasSubgroup Discussion Group
Expert Working Group NERFINISHED
Implementation Working Group NERFINISHED
Informal Working Group NERFINISHED
language English
operatedBy ICH Assembly NERFINISHED
partOf International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED
purpose to develop harmonised technical guidelines for pharmaceuticals
to facilitate more efficient drug development and registration
to improve the safety, quality and efficacy of pharmaceuticals
to reduce duplication of clinical and nonclinical studies
to revise existing ICH guidelines
to support global regulatory convergence for medicines
reportsTo ICH Assembly NERFINISHED
selectionCriteria technical expertise in relevant guideline topic
shortName ICH Working Groups NERFINISHED
topic efficacy of pharmaceuticals
multidisciplinary issues in pharmaceutical regulation
quality of pharmaceuticals
safety of pharmaceuticals
usesDocumentType ICH Guideline NERFINISHED
business plan
concept paper
step 2 draft guideline
step 4 final guideline
website https://www.ich.org

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ICH Assembly hasAuthorityOver ICH Working Groups