№ lp_1_14751
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Collection of EMA justification table templates outlining proposed redactions of commercially confidential information in clinical study modules submitted for regulatory review.
Date:
12 May 2025
Document Number:
EMA/152360/2016 rev.1
Modules:
2.5, 2.7.1, 2.7.2, 2.7.3, 2.7.4, 5.3.x.x
Type:
Regulatory submission template
Purpose:
Clinical overview, biopharmaceutical studies, clinical pharmacology, efficacy, safety, CSR body, CSR appendices
Applicant/MAH:
Not specified
Regulatory Agency:
European Medicines Agency
Confidentiality Guidance:
Annex 3 of POLICY/0070
Period:
2025
Price: 8 / 10 USD
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Year:
Not specified
Region / Country:
Not specified
Subject:
Conflicts of Interest and Confidentiality
Document type:
Declaration form
Organization / Institution:
European Medicines Agency (EMA)
Intended audience:
EMA Experts, Patients involved in EMA activities
Sections included:
Personal Details, Declaration of Interests, Confidentiality Undertaking
Time frame for declaration:
Last 3 years and any executive/lead roles in career
Format:
Electronic completion
Year:
2024
Region / city:
Europe
Theme:
Health Technology Assessment, Medicinal Products
Document type:
Template
Organization:
European Medicines Agency (EMA), HTACG
Author:
Not specified
Target audience:
Health Technology Developers (HTD), European regulatory bodies
Period of validity:
Not specified
Date of approval:
28 November 2024
Date of revisions:
Not specified
Year:
2025/2026
Region / City:
West Dunbartonshire
Subject:
Education Maintenance Allowance (EMA)
Document Type:
Guide
Organization / Institution:
West Dunbartonshire Council
Author:
West Dunbartonshire Council
Target Audience:
Students eligible for EMA
Validity Period:
2025-2026
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / City:
Europe
Topic:
Pharmaceutical Regulation
Document Type:
Position Paper
Organization / Institution:
EFPIA (European Federation of Pharmaceutical Industries and Associations)
Author:
EFPIA
Target Audience:
Regulatory authorities, pharmaceutical industry stakeholders
Effective Period:
Ongoing evaluation
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / City:
United Kingdom
Topic:
Electromagnetic Activities Research and Development
Document Type:
Prior Information Notice (PIN) Questionnaire
Organization:
Defence Science and Technology Laboratory (Dstl)
Target Audience:
Industry, academia, and suitably qualified experienced personnel (SQEP)
Period of Implementation:
Up to 5 years starting January 2025
Purpose:
Collect market feedback and insights for future EMA S&T research collaboration and development
Focus Areas:
Integration and synchronisation of EMA, Generation after Next (GAN) Electromagnetic Attack capabilities
Governance:
Leadership Team from Dstl and supplier, Consultation Group, Delivery Group
Scope:
TRL 1-6, primarily TRL 1-4 research taskings
Collaboration Model:
EMA Accelerator (EMAA) with end-to-end task management and industry/academic involvement
Year:
2019
Subject:
Nitrosamine risk assessment in pharmaceutical excipients
Document type:
Questionnaire and technical guidance
Regulatory reference:
European Medicines Agency nitrosamine review requirement
Related document:
Information on nitrosamines for marketing authorization holders (EMA/189634/2019)
Note:
Related document
Questions and answers on Information on nitrosamines for marketing authorization holders (EMA/CHMP/428592/2019 Rev. 1)
Industry sector:
Pharmaceutical manufacturing
Scope:
Evaluation of nitrosamine formation risks in excipient manufacturing processes
Prepared for:
Drug product manufacturers and Marketing Authorization Holders
Intended respondents:
Excipient suppliers and manufacturers
Regulatory authorities referenced:
European Medicines Agency, Health Canada, Therapeutic Goods Administration (Australia), Swissmedic
Key substances addressed:
Nitrites, nitrates, nitrosamines, secondary and tertiary amines
Manufacturing aspects covered:
Raw materials, intermediates, reagents, catalysts, solvents, water purification, recycled solvents, multipurpose equipment
Supporting content:
Guidance on nitrosating agents, amine sources, contamination risks, acceptable intake determination, and purge assessment principles
Year:
2026
Region / City:
Imaginary Town
Topic:
Power Generation, Installation Documentation
Document Type:
Installation Form
Organization / Institution:
ABC electricity distribution DNO
Author:
N/A
Target Audience:
Generator and Installer
Period of Validity:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Organization:
Health Resources and Services Administration
Office:
Office of Information Technology
Program:
Program Performance Reporting Systems
System:
HRSA Electronic Handbooks
Document type:
System overview and module catalog
Version:
1.0
Date:
04/11/2024
Author:
DME
Scope:
Enterprise grants, loans, and program performance reporting systems
Audience:
HRSA staff, grantees, applicants, reviewers
Covered systems:
EHBs, NOFO Navigator, DCPaaS
Change history:
Initial draft
Internal control:
Document Control – Change History
Year:
2020
Note:
Region / City
Topic:
Power Generating Modules, Compliance Requirements
Document Type:
Form B2-1
Target Audience:
Generator, Distribution Network Operator
Year:
2022
Region / city:
South Africa
Topic:
Nuclear energy, waste tracking system
Document type:
Invitation to bid
Organization / institution:
South African Nuclear Energy Corporation SOC Ltd (Necsa)
Author:
Unknown
Target audience:
Potential bidders
Period of validity:
90 days
Approval date:
Not specified
Amendment date:
Not specified
Description:
Invitation to bid for rewriting and implementation of a waste tracking software system and adding new modules for process enhancement.
Year:
Not specified
Region / City:
United States (implied by references to states and time zones)
Subject:
Employment and Education Outcomes Survey
Document Type:
Survey Instrument / Questionnaire
Organization:
Job Corps
Target Audience:
Former Job Corps students
Modules:
Verification of initial job placements, Q4 employment/earnings, educational placement, satisfaction
Data Collection Method:
Phone interviews with respondents and alternate contacts
Timeframe:
Q4 reporting period
Includes:
Instructions for interviewers, scripts for answering machines, contact procedures, and appendices for callback and military questions
Note:
Year
Context:
Application form for connecting power generating modules to the electricity distribution network, specifying conditions and requirements for multiple customers sharing power output.
Year:
2016
Region / City:
Hull
Theme:
Higher Education, Grading Criteria
Document Type:
Academic Policy
Organization / Institution:
University of Hull
Author:
University of Hull
Target Audience:
Students, Academic Staff
Period of Validity:
From 1st September 2016
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Context:
Detailed overview of the Workday Recruiting modules, including job requisition management, candidate tracking, and recruitment process configuration.
Year:
2024
Region / City:
South Africa
Topic:
Real Estate Education
Document Type:
Course Overview
Organization / Institution:
FK Consulting
Author:
Freda Kooij, Dominique Marais
Target Audience:
Real Estate Agents
Period of Validity:
From 1 July 2024
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
N/A
Theme:
Cryptographic Testing
Document Type:
Technical Report
Organization / Institution:
NIST
Author:
N/A
Target Audience:
Security Testers
Effective Period:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Note:
Year
Contextual description:
The document is a guide to configuring ERP processes for sales and distribution modules in SAP S/4HANA using the Pen Company example, with step-by-step exercises.
Note:
Year
Contextual description:
A guide detailing SAP S/4HANA system configuration for Financial Accounting and Materials Management modules, focusing on organizational structures, company code creation, and credit control setup.