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This document serves as a companion guide to the MedDRA Points to Consider documents, providing additional details and specific examples on coding and analysis for MedDRA users in the pharmaceutical industry and regulatory bodies.
Year:
2020
Region / City:
International
Subject:
MedDRA, Data Quality, Medication Errors, Product Quality
Document Type:
Guide
Organization / Institution:
International Council for Harmonisation (ICH)
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA users, regulatory bodies, pharmaceutical companies
Effective Period:
Ongoing
Approval Date:
October 2020
Revision Date:
N/A
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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
Year:
2015
Region / city:
Global
Subject:
MedDRA Term Selection Changes
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA Users
Period of validity:
Not specified
Approval date:
1 March 2015
Date of changes:
March 2015
Year:
2014
Region / city:
International
Subject:
MedDRA terminology
Document Type:
Guide
Organization / Institution:
ICH (International Council for Harmonisation)
Author:
Working Group of ICH Steering Committee
Target Audience:
MedDRA users
Period of validity:
Since September 2014
Approval Date:
1 September 2014
Date of Changes:
September 2014
Contextual description:
Guide detailing changes and updates in MedDRA Term Selection for users, including updates for congenital and acquired conditions, medication errors, and examples based on MedDRA version 17.1.
Year:
2022
Region / city:
International
Theme:
Medical terminology, Regulatory activities
Document type:
Guide
Organization:
International Council for Harmonisation (ICH)
Author:
ICH Management Committee
Target audience:
MedDRA users, healthcare professionals, regulatory authorities
Effective period:
March 2022
Date of approval:
March 2022
Date of changes:
Annually updated
Endorsements:
ICH-endorsed
License:
Public license with copyright acknowledgment
Copyright:
ICH
Modification:
Content adaptation allowed with proper acknowledgment
Summary:
A guide for selecting terms from the MedDRA terminology, aimed at users in the regulatory and medical fields.
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
Year:
2025
Region / City:
Global
Topic:
MedDRA Term Selection
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH Working Group
Target Audience:
Regulatory professionals, MedDRA users
Period of validity:
Until the next update (Annual)
Approval Date:
March 2025
Date of changes:
N/A
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
Year:
2015
Region / city:
Global
Subject:
MedDRA Term Selection Changes
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA Users
Period of validity:
Not specified
Approval date:
1 March 2015
Date of changes:
March 2015
Year:
2014
Region / city:
International
Subject:
MedDRA terminology
Document Type:
Guide
Organization / Institution:
ICH (International Council for Harmonisation)
Author:
Working Group of ICH Steering Committee
Target Audience:
MedDRA users
Period of validity:
Since September 2014
Approval Date:
1 September 2014
Date of Changes:
September 2014
Contextual description:
Guide detailing changes and updates in MedDRA Term Selection for users, including updates for congenital and acquired conditions, medication errors, and examples based on MedDRA version 17.1.
Year:
2025
Region / City:
Global
Topic:
MedDRA Data Retrieval and Presentation
Document Type:
Guide
Organization:
International Council for Harmonisation (ICH)
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA users, industry professionals, regulatory bodies
Period of Effectiveness:
March 2025
Approval Date:
March 2025
Revision Date:
N/A
Year:
2020
Region / City:
Global
Subject:
Medical Terminology, Data Retrieval
Document Type:
Guide
Organization:
International Council for Harmonisation (ICH)
Author:
ICH Working Group
Target Audience:
Regulatory Authorities, Pharmaceutical Industry Professionals
Validity Period:
Ongoing
Approval Date:
March 2020
Modification Date:
N/A
Year:
2022
Region / city:
International
Theme:
Medical terminology, Regulatory activities
Document type:
Guide
Organization:
International Council for Harmonisation (ICH)
Author:
ICH Management Committee
Target audience:
MedDRA users, healthcare professionals, regulatory authorities
Effective period:
March 2022
Date of approval:
March 2022
Date of changes:
Annually updated
Endorsements:
ICH-endorsed
License:
Public license with copyright acknowledgment
Copyright:
ICH
Modification:
Content adaptation allowed with proper acknowledgment
Summary:
A guide for selecting terms from the MedDRA terminology, aimed at users in the regulatory and medical fields.
Year:
2014
Region / Organization:
International (ICH, EU, Japan, USA, Canada)
Subject:
Regulatory terminology for medical products
Document type:
Guidance document
Authority:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Authors:
ICH Points to Consider Working Group, MedDRA Maintenance and Support Services Organization (MSSO), Japanese Maintenance Organization
Version:
4.7
Based on MedDRA Version:
17.0
Intended audience:
MedDRA users in regulatory and industry settings
Date of release:
March 2014
Content:
Guidance on selection of MedDRA terms for reporting adverse events, diagnoses, and related clinical information
Scope:
Covers term selection principles, use of medical judgment, and special cases including congenital conditions, neoplasms, medication errors, overdose, device-related terms, and off-label use
References:
MedDRA browsing tools and related regulatory documentation