№ lp_1_2_35714
File format: docx Character count: 107371 File size: 789 KB
The document provides supplementary guidance to MedDRA users with detailed explanations on specific topics of regulatory importance related to MedDRA use.
Year: 2024
Region / City: Global
Topic: MedDRA, Data Quality, Medication Errors, Product Quality, Manufacturing Issues
Document Type: Guide
Organization / Institution: ICH
Author: ICH Management Committee
Target Audience: MedDRA users, Regulatory bodies, Industry members
Effective Period: Ongoing
Approval Date: September 2024
Date of Changes: Not specified
Price: 8 / 10 USD
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MedDRA® TERM SELECTION: POINTS TO CONSIDERICH-Endorsed Guide for MedDRA UsersRelease 4.2425March 2024
Year: 2024
Region / city: Global
Topic: MedDRA term selection, regulatory activities, medical terminology
Document type: Guide
Organization / institution: International Council for Harmonisation (ICH)
Author: ICH Working Group
Target audience: MedDRA users, regulatory bodies, industry professionals
Validity period: Annual updates (March release)
Approval date: March 2024
Amendment date: Not specified
Topics: DOCUMENTICH-Endorsed 30September UsersRelease