№ lp_2_3_64065
File format: docx
Character count: 18137
File size: 47 KB
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.
Price: 8 / 10 USD
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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
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:
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:
2017
Region / City:
N/A
Topic:
Healthcare Integration
Document Type:
Technical Specification
Organization / Institution:
athenahealth, Inc.
Author:
N/A
Target Audience:
Healthcare Providers, IT Managers, Project Managers
Effective Period:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2025
Region / city:
Wuhan, China
Topic:
AI for 6G architecture
Document Type:
Meeting Contribution
Organization:
Huawei, China Mobile, HiSilicon, Vivo, Oppo, Boost Mobile Network, NEC, Futurewei, Deutsche Telekom, Oracle
Author:
Huawei, China Mobile, HiSilicon, Vivo, Oppo, Boost Mobile Network, NEC, Futurewei, Deutsche Telekom, Oracle
Target Audience:
Telecom industry professionals, AI researchers, 6G developers
Period of validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / City:
Geneva
Topic:
Vehicle Regulations, Driver Assistance Systems
Document Type:
Proposal
Organization:
United Nations Economic Commission for Europe
Author:
Task Force on Advanced Driver Assistance System
Target Audience:
Type Approval Authorities, Vehicle Manufacturers
Period of Validity:
Ongoing
Approval Date:
9 April 2025
Date of Changes:
N/A
Year:
2025
Organization:
United Nations Economic Commission for Europe (ECE)
Committee:
Inland Transport Committee, World Forum for Harmonization of Vehicle Regulations (WP.29/GRVA)
Document type:
Proposal / Regulatory amendment
Language:
English
Location:
Geneva, Switzerland
Session:
Twenty-first session
Dates of session:
20–24 January 2025
Topic:
Advanced Driver Assistance Systems (ADAS), Driver Control Assistance Systems (DCAS)
Submitted by:
Task Force on Advanced Driver Assistance System (ADAS) experts
Reference:
ECE/TRANS/WP.29/GRVA/2025/xx
Year:
2024
Region / city:
United Nations
Theme:
Driver Control Assistance Systems (DCAS)
Document type:
Guidance Document
Organization / institution:
United Nations Economic Commission for Europe (UNECE)
Author:
TF on ADAS Chair
Target audience:
Type Approval Authorities
Effective period:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2022
Region / city:
United States
Topic:
Medical imaging, VIX system
Document type:
Technical guide
Organization / institution:
Department of Veterans Affairs, Office of Information and Technology (OIT)
Author:
VA IT VistA Imaging Technical team
Target audience:
IT professionals in the Department of Veterans Affairs
Period of validity:
November 2022 onwards
Approval date:
November 2022
Revision date:
November 2022
Year:
2025
Date of issuance:
8 April 2025
Session:
Twenty-second session
Meeting date:
24 June 2025
Location:
Geneva
Agenda item:
6(a) Advanced Driver Assistance Systems: Driver Control Assistance Systems
Document symbol:
ECE/TRANS/WP.29/GRVA/2025/29
Distribution:
General
Original language:
English
Organization:
United Nations Economic Commission for Europe
Governing body:
Inland Transport Committee, World Forum for Harmonization of Vehicle Regulations (WP.29)
Working party:
Working Party on Automated/Autonomous and Connected Vehicles (GRVA)
Submitting body:
Task Force on Advanced Driver Assistance System
Related regulation:
UN Regulation No. 171
Subject:
Use of the secure internet database “DETA” for exchange of information on DCAS-related incidents between Type Approval Authorities
Legal framework:
1958 Agreement
Related documents:
ECE/TRANS/WP.29/2024/37; ECE/TRANS/WP.29/2024/146; ECE/TRANS/WP.29/2025/7; DETA-52-03-Rev.3; ECE/TRANS/WP.29/2022/61
Type of document:
Proposal and guidance document
Year:
2022
Date:
October 11, 2022
Series:
What the Hell Is Going On? Podcast
Episode Number:
171
Topic:
Nuclear escalation risks in the Russia–Ukraine war and U.S. political discourse
Type of Document:
Podcast transcript
Organization:
American Enterprise Institute
Hosts:
Danielle Pletka; Marc Thiessen
Guest:
Frederick Kagan
Country Focus:
United States; Russia; Ukraine
Key Figures Discussed:
Joe Biden; Vladimir Putin
Political Context:
U.S. domestic politics and the war in Ukraine
Format:
Recorded discussion transcript
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:
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
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:
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