№ lp_1_36064
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File size: 251 KB
This document specifies the Thai Module 1 schema and regional information for eCTD submissions to the Thai FDA, guiding the preparation of regulatory dossiers in eCTD format.
Year:
2015
Region / City:
Thailand
Topic:
eCTD Specification, Regulatory Submission, Pharmaceutical Industry
Document Type:
Technical Specification
Organization / Institution:
Thai FDA
Author:
Thai FDA
Target Audience:
Pharmaceutical companies, regulatory professionals
Validity Period:
Ongoing
Approval Date:
01/12/2015
Date of Changes:
Not specified
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Topic:
eCTD, registration dossier, Ministry of Health of Ukraine
Document Type:
Order
Organization / Institution:
Ministry of Health of Ukraine
Target Audience:
Regulatory authorities, applicants for medicinal product registration
Year:
2009
Region / city:
South Africa
Subject:
Registration of medicines
Document type:
Guideline
Organization / institution:
South African Health Products Regulatory Authority (SAHPRA)
Author:
Not specified
Target audience:
Applicants for registration of medicines
Period of validity:
Ongoing
Date of approval:
Not specified
Date of amendments:
May 2019
Version:
7
Date of implementation:
June 2011
Deadline for comment:
September 30, 2010
Year:
Not specified
Jurisdiction:
South Africa
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Document type:
Regulatory validation checklist
Document format:
eCTD
Subject area:
Medicinal product variations
Product type:
Human medicinal products
Application type:
Variation application
Intended submitter:
Holder of certificate of registration
Submission scope:
Administrative, technical, and business validation
Regulatory modules referenced:
CTD Modules 1–5
Use context:
Initial and follow-up eCTD sequences
Approval status fields:
Included
Language:
English
Year:
2024
Region / City:
European Union
Topic:
eCTD Implementation
Document Type:
Technical Guide
Organization / Institution:
Health Level Seven (HL7)
Author:
Not specified
Target Audience:
Regulatory bodies, developers, and industry professionals involved in eCTD implementation
Effective Period:
2024
Approval Date:
March 2024
Date of Changes:
March 2024
Version:
1.2
Date:
4th of October 2024
OID:
2.16.840.1.113883.3.989.5.1.1.6.1.2
Document Change History:
2012-2024
Year:
2024
Region / City:
EU
Theme:
Electronic submission, regulatory requirements
Document Type:
Technical Guide
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Regulatory bodies, pharmaceutical industry
Effective Period:
2024 and beyond
Approval Date:
4th October 2024
Modification Date:
N/A
Year:
2001
Type of document:
Regulatory guidance
Scope:
Pharmacokinetics data reporting for nonclinical studies
Applicable region:
International (ICH)
Referenced guidelines:
M4 Organization of the Common Technical Document, M4S: The CTD — Safety and Safety Appendices
Target audience:
Pharmaceutical industry, regulatory affairs professionals
Document format:
Templates and tables for data presentation
Key topics:
Absorption, distribution, metabolism, excretion, plasma protein binding, study in pregnant or nursing animals
Year:
N/A
Region / City:
N/A
Subject:
Pharmaceutical Documentation, eCTD
Document Type:
Regulatory Guidance
Organization / Institution:
FDA
Author:
N/A
Target Audience:
Pharmaceutical Industry
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2023
Region / City:
South Africa
Topic:
eCTD validation for new registration of medicinal products
Document Type:
Template
Organization:
SAHPRA
Author:
Not specified
Target Audience:
Applicants submitting new registration applications for medicinal products in eCTD format
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
Note:
Year
Topic:
ICT Products and Services
Document Type:
Order Form
Year:
2026
Region / City:
Canton, MA, USA
Document Type:
Installation Specification
Organization:
Sika Corporation
Author:
Sika Corporation Technical Services
Target Audience:
Roofing Applicators, Licensed Electricians
Scope:
Installation of Sarnafil adhered roofing system with SSM-2 PV module racking system, including membrane, flashings, insulation, and related components
Warranty:
Sika Corporation Warranty, Roofing Applicator Warranty
Standards Compliance:
ASCE 7, FM Global 4470, UL 2703, UL 1703
Safety Guidelines:
OSHA regulations, SDS handling instructions
Storage Conditions:
Temperature 4°C–27°C for adhesives, protection from moisture and fire hazards
Note:
Year
Document Type:
KB Article
Year:
2023
Region / City:
Freiburg
Subject:
Higher Education, Curriculum Development
Document Type:
Template
Organization / Institution:
University of Freiburg, Higher Education Didactics and Digital Learning and Teaching Development unit
Author:
Lisa Hüther-Pape, Nele Koehler, Sonja Hinterseh, Carolin Wagner
Target Audience:
Academic institutions, faculty, students involved in module handbook creation
Validity Period:
Not specified
Approval Date:
Not specified
Revision Date:
June 2019
Year:
11
Region / city:
New South Wales
Subject:
Physics
Document type:
Educational module
Organ / institution:
NSW Education Standards Authority (NESA)
Author:
Not specified
Target audience:
High school students, teachers
Period of validity:
2017
Approval date:
2017
Date of changes:
Not specified
Year:
2017
Region / city:
New South Wales
Subject:
Earth and Environmental Science
Document type:
Curriculum guide
Authority / institution:
NSW Education Standards Authority (NESA)
Author:
NESA
Target audience:
Students and educators
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
Not specified
Theme:
Automotive Power Modules, Reliability, Qualification
Document Type:
Presentation
Organization / Institution:
Wolfspeed
Author:
Robert Shaw
Target Audience:
Automotive manufacturers, power electronics suppliers, reliability engineers
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2018–2019
Region / city:
New South Wales, Australia
Subject:
Physics
Module:
Electromagnetism
Course level:
Year 12, Stage 6
Type:
Educational syllabus guide
Publisher / Institution:
NSW Education Standards Authority
Target audience:
Teachers and Year 12 students
Related modules:
Motion, light, atomic theory, universe
Skills emphasized:
Working scientifically, data analysis, practical investigations
Core concepts:
Electric fields, magnetic fields, electromagnetic induction, motor effect
Teaching strategies:
Inquiry-based learning, addressing misconceptions, extended concepts
Resources:
Websites, studies, papers, SI revision documents
Appendices:
Pre-tests, investigations, past exam questions, right-hand rules
Year:
2018-2019
Region / City:
New South Wales, Australia
Topic:
Chemistry
Document Type:
Educational Guide
Organization / Institution:
NSW Department of Education
Author:
NSW Department of Education
Target Audience:
Teachers of Year 12 Chemistry
Effective Period:
2018-2019
Approval Date:
Not specified
Date of Changes:
Not specified