№ lp_1_2_49942
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Character count: 27525
File size: 70 KB
This document provides a template for creating Periodic Safety Update Reports (PSURs) for medical devices, summarizing post-market surveillance activities and related data.
Year:
2022
Note:
Region / City
Theme:
Post-market surveillance, safety reporting
Document Type:
Template
Author:
MDCG
Target Audience:
Manufacturers of medical devices
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Year:
2025
Region / city:
European Union
Topic:
Pharmacovigilance, PSUR Follow-Up
Document Type:
Report
Organ / institution:
CMDh
Author:
Lead Member State
Target Audience:
Health authorities, pharmaceutical companies, regulatory bodies
Period of validity:
February 2025 onwards
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Contextual description:
A regulatory submission form for post-marketing safety updates on human medicines, including details of the product, safety variations, and exposure data for Switzerland and worldwide.
Year:
2015
Type of document:
Assessment report template
Subject:
Pharmacovigilance, Periodic Safety Update Reports (PSUR)
Organization:
European Medicines Agency (EMA)
Target audience:
Lead Member States, MAHs, PRAC members
Procedure number:
Not specified
Data lock point:
Not specified
Status:
Guidance and procedural template
References:
GVP Module V, VII, VIII; Variations Classification guideline Commission Regulation 1234/2008; HMA/EMEA recommendations EMEA/743133/2009
Year:
2016
Note:
Region / city
Subject:
Post-audit functionality, Notifications, API
Document Type:
Release Notes
Organization:
EMA
Target Audience:
NCA users, MAHs, EMA
Date of Changes:
06 Jan 16
Year:
2026
Organization:
European Medicines Agency (EMA)
Document Type:
Account Request Form
Target Audience:
NCA Staff
Purpose:
Request access to PSUR Repository
Data Protection Compliance:
Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EC) No 45/2001
Contact Email:
[email protected]
Instructions:
Fill personal and work information, specify account use and user type, agree to ECD policy
Year:
2020
Country:
Mongolia
Document type:
Periodic report
Issuing body:
Committee on Economic, Social and Cultural Rights / United Nations Economic and Social Council
Date received:
9 July 2021
Language:
English
Coverage:
Social and economic rights, labor and employment, social welfare, minimum wage, public sector salaries, vulnerable populations
Programs mentioned:
Food and Nutrition Programme for Poorest Families, Age Benefit Programme
Target groups:
Civil servants, teachers, doctors, nurses, cultural and art workers, poor households, seniors
Legal framework referenced:
Law on Civil Service (2017), Social Welfare Law, Law on Seniors
Salary data period:
2016–2020
Budget allocations:
MNT 159.8 billion for salary increase (2020), MNT 302.5 billion for employment duration payment, additional MNT 15.5 billion for food support during COVID-19 lockdown
Year:
2025
Region / City:
United Kingdom
Topic:
Nuclear safety review
Document Type:
Report
Organization / Institution:
Office for Nuclear Regulation (ONR)
Author:
EDF Nuclear Generation Ltd
Target Audience:
Regulatory bodies, nuclear safety authorities
Period of validity:
2025-2035
Approval date:
January 2025
Date of amendments:
N/A
Year:
XXXX
Region / City:
XXX
Theme:
Post-market Surveillance
Document Type:
Report
Organization:
XXX
Author:
XXX
Target Audience:
Regulatory Authorities, Healthcare Professionals
Period of Validity:
[start date] - [end date]
Approval Date:
YYYY-MM-DD
Revision Date:
YYYY-MM-DD
Year:
2023
Region / City:
United States
Subject:
Calibration, Standards, Metrology
Document Type:
Policy Recommendations
Author:
National Institute of Standards and Technology (NIST)
Target Audience:
State laboratories, metrologists, policy makers
Period of Validity:
Ongoing
Approval Date:
2023
Amendment Date:
Not specified
Year:
Not specified
Region / City:
Not specified
Topic:
Atomic radius, electronegativity, ionization energy, periodic trends
Document type:
Educational material
Author:
Not specified
Target audience:
Students studying chemistry
Effective date:
Not specified
Modification date:
Not specified
Context:
Educational material for students to analyze periodic trends using graphs based on the periodic table.
Year:
2022
Region / city:
Republic of Korea
Document type:
Report
Organization:
Committee on the Elimination of Discrimination against Women (CEDAW)
Author:
Republic of Korea, Ministry of Gender Equality and Family (MOGEF), Korean Women’s Development Institute
Target audience:
Governments, human rights organizations, gender equality advocates
Period of validity:
Ongoing
Approval date:
2022
Date of changes:
N/A
Year:
2024
Region / City:
Serbia
Topic:
Civil and Political Rights
Document Type:
Concluding Observations
Organ / Institution:
Human Rights Committee
Author:
United Nations Human Rights Committee
Target Audience:
Governments, NGOs, legal professionals
Period of Validity:
2024
Approval Date:
26 March 2024
Date of Last Revision:
N/A
Author:
Gregg Henriques
Type of document:
Academic essay
Field:
Philosophy of science, Behavioral science
Target audience:
Graduate students, researchers
Key concepts:
Theory of Knowledge System, Periodic Table of Behavior, behavioral complexity
Dimensions covered:
Matter, Life, Mind, Culture
Levels analyzed:
Particle, Atomic, Molecular, Genetic, Cellular, Organism, Neuroscience, Psychology, Sociobiology, Cognitive Science, Human Psychology, Social Sciences
Date:
Not specified
Note:
Year
Subject:
Covid risk management
Document type:
Report
Organization / institution:
University
Contextual description:
A report documenting the periodic review of local Covid risk management arrangements for SS1 and SS2, including updates and changes to the overarching risk assessment and related appendices.
Year:
2021
Region / City:
Whatcom County, Bellingham, WA
Theme:
Shoreline Management, Environmental Policy
Document Type:
Guide
Organization:
Whatcom County Council
Author:
Whatcom County Council
Target Audience:
County residents, Planning Commission, Department of Ecology, local stakeholders
Action Period:
2021
Approval Date:
March 9, 2021
Date of Changes:
N/A
Year:
2022
Region / city:
Azerbaijan
Topic:
Racial discrimination, Human rights, Conflict-related human rights violations
Document type:
Concluding observations
Organization / institution:
United Nations Committee on the Elimination of Racial Discrimination
Author:
United Nations Committee on the Elimination of Racial Discrimination
Target audience:
Government officials, Human rights advocates, International organizations
Period of validity:
Not specified
Date of approval:
26 August 2022
Date of amendments:
Not specified
Year:
2023
Region / City:
USA
Theme:
Research positions review
Document type:
Instruction manual
Organization:
Department of Veterans Affairs (VA)
Author:
Not specified
Target audience:
VA personnel, Research Scientists
Effective period:
Ongoing
Approval date:
Not specified
Date of changes:
Red text indicates updates
Year:
2025
Region / city:
Aotearoa New Zealand
Topic:
Human rights, racial discrimination, Indigenous rights
Document type:
Periodic review submission
Organization / institution:
Te Kāhui Tika Tangata New Zealand Human Rights Commission
Author:
Te Kāhui Tika Tangata New Zealand Human Rights Commission
Target audience:
UN Committee on the Elimination of All Forms of Racial Discrimination, human rights professionals, policymakers
Period of validity:
2018–2025
Approval date:
19 May 2025
Date of amendments:
None specified
Note:
Context
Year:
2025
Region / city:
Fiji
Theme:
Human Rights, Gender Equality, Women’s Rights, COVID-19
Document Type:
Written Submission
Organization:
Human Rights and Anti-Discrimination Commission, Fiji
Author:
Fiji Human Rights and Anti-Discrimination Commission
Target Audience:
CEDAW Committee, policymakers, human rights advocates, gender equality organizations
Period of validity:
2025
Approval Date:
4 April 2025
Date of revisions:
None
Note:
Year