№ files_lp_3_process_9_63341
File format: docx
Character count: 79462
File size: 232 KB
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
2022
Note:
Region / City
Theme:
Post-market surveillance, safety reporting
Document Type:
Template
Author:
MDCG
Target Audience:
Manufacturers of medical devices
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:
2026
Region / City:
Helsinki, Finland
Topic:
Biocides, Wood preservatives
Document type:
Repository document
Organization:
European Chemicals Agency
Author:
European Chemicals Agency
Target audience:
Stakeholders in biocides and wood preservation
Validity period:
Not specified
Approval date:
January 2026
Amendment date:
Not specified
Organization:
National Aeronautics and Space Administration (NASA)
Program:
Space Telecommunications Radio System (STRS)
Document type:
Submittal checklist
Intended submitters:
NASA personnel; SBIR/STTR contractors
Scope:
STRS Application Repository submissions
Standards referenced:
NASA-STD-4009; NPR 7150.2; CMMI
Related systems:
STRS Application Repository; NASA Software Release System
Submission content:
Software, documentation, metadata, compliance evidence
Date:
2018-02-26
Checklist version:
v4009A
Compliance areas:
Software release, metadata, testing, licensing, platform-specific wrappers
Repository management roles:
STRS Repository Manager; submitter
Year:
2020
Region / city:
East region
Topic:
Health care data management
Document Type:
Technical specification
Organization / Institution:
TRICARE
Author:
N. Bowling
Target audience:
TRICARE contractors, healthcare providers, data analysts
Period of validity:
Ongoing
Approval Date:
12/17/2020
Date of changes:
12/17/2020
Year:
2012
Region / City:
N/A
Subject:
Historical Data Management
Document Type:
Technical Specification
Organization / Institution:
N/A
Author:
D. Sexton
Target Audience:
Developers, Data Managers
Period of Validity:
N/A
Approval Date:
01/07/2012
Date of Changes:
N/A
Year:
2019
Region / City:
United States
Subject:
Health Connect Deployment and Installation Guide
Document Type:
Guide
Organization / Institution:
Department of Veterans Affairs (VA), Office of Information and Technology (OIT)
Author:
REDACTED
Target Audience:
Stakeholders, support personnel, VA administrators
Period of Validity:
N/A
Approval Date:
June 2019
Revision Date:
June 2019
Year:
2016
Region / City:
N/A
Topic:
Data Management / System Integration
Document Type:
Technical Specification
Organization / Institution:
N/A
Author:
T. Comer
Target Audience:
System developers, data administrators
Effective Period:
N/A
Approval Date:
09/27/2016
Revision Date:
N/A
Change History:
Initial versioning
Content:
This document specifies the structure, transmission, and transformation processes for the MTF Location File within the MHS Data Repository (MDR), focusing on linking workload and personnel data from CHCS to MHS Genesis system.
Year:
2009
Original approval date:
April 6, 2005
Modification date:
June 16, 2009
Document type:
Interface Control Document
System source:
Composite Health Care System (CHCS)
Receiving system:
Military Health System Data Repository (MDR)
Managing organization:
Defense Health Services Systems Program Office
Contributing organization:
Defense Health Information Management Systems Program Office
Subject area:
Health information systems data exchange
Data type:
Appointment data
Operational scope:
Medical Treatment Facilities
Configuration control authority:
DHSS Program Office
Year:
2012
Region / City:
N/A
Topic:
Data Integration, Patient Identification
Document Type:
Technical Specification
Organization:
MHS (Military Health System)
Author:
Joe Shoemaker, Wendy Funk
Target Audience:
Developers, Data Analysts
Period of Validity:
Ongoing (Monthly Updates)
Approval Date:
07/20/2006
Revision Date:
11/07/2012
Year:
2020
Region / City:
Not specified
Topic:
Military Health System, Data Processing, Healthcare for Veterans
Document Type:
Specification
Organization / Institution:
Not specified
Author:
W. Funk, L. Hopkins
Target Audience:
Military Healthcare Personnel
Effective Period:
Ongoing
Approval Date:
Not specified
Date of Changes:
09/02/2020
Year:
2015
Region / city:
N/A
Topic:
Dental Readiness Classification
Document Type:
Technical specification
Organization / institution:
N/A
Author:
C. Kangas, W. Funk, A. Hong, D. McDonald
Target Audience:
Military healthcare personnel, data processors
Effective Period:
Monthly updates
Approval Date:
22 January 2015
Amendment Date:
01/22/2014
Background:
The Dental Readiness File (DRF) outlines the dental readiness status of Active Duty Service Members (ADSM) and Guard/Reserve members, with updates from several data sources and regular monthly processing.
Year:
2020
Note:
Region / City
Topic:
Data Processing, Field Transformation
Document Type:
Technical Specification
Author:
D. Juckett
Target Audience:
Data Analysts, System Developers
Effective Period:
From FY04 onwards
Approval Date:
26 October 2020
Year:
2026
Region / city:
Helsinki, Finland
Topic:
Biocides regulation, emission scenarios
Document type:
Repository document
Organization:
European Chemicals Agency
Author:
European Chemicals Agency
Target audience:
Biocide product manufacturers, regulatory bodies
Period of validity:
January 2026
Approval date:
January 2026
Amendment date:
N/A
Year:
2021
Region / city:
Unknown
Topic:
SMKI Repository Interface
Document type:
Technical Specification
Organization / institution:
DCC
Author:
Unknown
Target audience:
Parties, RDPs, SMKI PMA, Panel, Code Administrator
Period of validity:
Unknown
Approval date:
Unknown
Amendment date:
Unknown
Note:
Year