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.

All labels observed (2)

Label Occurrences
ICH Working Groups canonical 4
Implementation Working Group 1

How this entity was disambiguated

Statements (50)

Predicate Object
instanceOf ICH body
expert committee
technical working group
coordinatedBy ICH Secretariat
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
Implementation Working Group
linked to: ICH Working Groups

Informal Working Group
language English
operatedBy ICH Assembly
partOf International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
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
selectionCriteria technical expertise in relevant guideline topic
shortName ICH Working Groups
topic efficacy of pharmaceuticals
multidisciplinary issues in pharmaceutical regulation
quality of pharmaceuticals
safety of pharmaceuticals
usesDocumentType ICH Guideline
business plan
concept paper
step 2 draft guideline
step 4 final guideline
website https://www.ich.org

How these facts were elicited

Referenced by (5)

Full triples — surface form annotated when it differs from this entity's canonical label.

ICH Assembly hasAuthorityOver ICH Working Groups
ICH Working Groups shortName ICH Working Groups
ICH Working Groups hasSubgroup Implementation Working Group
linked to: ICH Working Groups
ICH Secretariat supportsOrganization ICH Working Groups
subject linked to: Secretariat
ICH Rules of Procedure usedBy ICH Working Groups