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 ⓘ