№ lp_2_1_17703
File format: docx
Character count: 2681
File size: 394 KB
Year:
2025
Region / City:
Haifa, Israel
Topic:
Quality Management System Regulation (QMSR)
Document Type:
Training Overview
Organization:
Not specified
Author:
Dr. Sivan Luder
Target Audience:
Professionals in the medical device industry (Quality, Regulatory, R&D, Manufacturing, Engineering, Clinical teams)
Effective Period:
Until 2026
Approval Date:
Not specified
Modification Date:
Not specified
Context:
Training document on the new U.S. FDA QMSR regulation, aimed at helping professionals in the medical device industry prepare for its full implementation.
Price: 8 / 10 USD
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Year:
2025
Region:
Asia Pacific
Country:
Timor-Leste
Project Type:
Full Sized Project (FSP)
Duration Planned (months):
72
Duration Elapsed (months):
25
GEF ID:
10713
Grant ID:
S1-32LDL-000062
GEF Focal Areas:
Climate Change Adaptation, Land Degradation
GEF Financing Amount:
$9,845,662
Co-financing Amount:
$33,100,000
Date of CEO Endorsement:
2023-05-17
UNEP Project Approval Date:
2023-10-02
Start of Implementation:
2023-10-02
Date of First Disbursement:
2024-05-02
Total Disbursement as of 30 June 2025:
$500,000
Total Expenditure as of 30 June 2025:
$50,139
Expected Completion Date:
2030-06-30
Implementing Division:
Ecosystems Division
Executing Agency:
Directorate of Climate Change – State Secretary for the Environment
Co-implementing Agency:
UNDP
Other Project Partners:
RIKOLTO, Progreso Foundation, PT Profil Mitra Abadi, Sucafina, UNEP, GCF UNDP Project
UNEP Portfolio Manager:
Kavita Sharma
UNEP Task Manager:
Bunchin Bazartsaren
UNEP Finance Officer:
Pricillah Kaara
Project Manager:
Carion Da Costa
Finance Manager:
Benjamin Pinto
Session:
Janvier 2023 – 1er semestre
Titulaire(s) du cours:
Mme Juliette Ringeisen-Biardeaud et Mme Claire Wrobel
Durée de l’épreuve:
1h30
Document(s) autorisé(s):
Aucun
Périodité:
1 semestre
Lieu:
Paris
Type de document:
Examen
Contexte:
Examen portant sur l’adaptation du droit commun aux enjeux contemporains et à l’ère numérique.
Note:
Publication Date
Year:
2019
Region / City:
USA
Topic:
Outcome measurement, library services
Document Type:
Report
Organization / Institution:
Association of College & Research Libraries, Public Library Association
Author:
Eric Ackermann, Sara Goek, Emily Plagman
Target Audience:
Library professionals, researchers, academic libraries
Implementation Period:
2018-2019
Approval Date:
2019
Date of Changes:
N/A
Year:
2025
Region / city:
Cameroon
Topic:
Cyber-physical security, energy sector, continuous verification
Document type:
Research study
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, energy sector professionals
Period of applicability:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023-2024
Type of document:
Master Thesis
Author:
Cal Hofman
Supervisors:
Joost de Laat & Joep Keuzenkamp
Keywords:
adaptation aid, climate financing, donor behaviour, aid models
JEL codes:
C32, F35, Q54
Institution:
Utrecht University
Target audience:
Researchers, policymakers in climate finance and development aid
Period studied:
2010-2021
Data sources:
OECD adaptation aid projects, Clist’s 4Ps framework
Methodology:
Double hurdle regression model
Focus region:
Low-income and Least Developed Countries (LDCs)
Analysis perspective:
Bilateral donor allocation of climate adaptation aid
Year:
2021
Event:
Surveys & Insights Conference
Date:
28 April 2021
Deadline for submissions:
28 January 2021
Location:
Virtual (Advance HE platform)
Theme:
Higher education student experience, survey insights, adapting to challenges
Document type:
Call for proposals / Conference guide
Target audience:
Academics, practitioners, student experience specialists, policymakers, research professionals
Conference streams:
Keynote sessions, panel sessions, virtual workshops, on-demand presentations, virtual posters
Focus areas:
Student engagement, quality of learning, BAME student experience gap, student wellbeing
Submission formats:
On-demand oral presentation, live workshop session, virtual poster presentation
Year:
2014
Region / City:
Sacramento, CA
Subject:
Criminal Justice, Mental Health, Law Enforcement
Institution:
California State University, Sacramento
Author:
Kimberly Lorraine Vester
Target Audience:
Law enforcement professionals, criminal justice practitioners, mental health experts
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Revision:
Not specified
Year:
2023
Region / City:
Edinburgh
Theme:
Curatorial Concept, Exhibition Design, Rural Art
Document Type:
Blog Post
Institution:
University
Author:
[Not specified]
Target Audience:
Art Students, Curators, Academics
Period of Activity:
Week 4
Approval Date:
[Not specified]
Modification Date:
[Not specified]
Year:
2016
Region / City:
United States
Topic:
Electronic Informed Consent (eIC)
Document Type:
Guidance
Agency / Institution:
Office for Human Research Protection (OHRP), Food and Drug Administration (FDA)
Author:
Office for Human Research Protection (OHRP), FDA
Target Audience:
Researchers, IRBs, Clinical Investigators, and Study Participants
Period of Validity:
Ongoing
Approval Date:
December 2016
Date of Revisions:
Not specified
Year:
2013–2019
Region:
United States
Subject:
Medical device regulatory submissions
Document type:
Regulatory guidance
Program:
FDA Q-Submission (Q-Sub) Program
Regulatory authority:
U.S. Food and Drug Administration
Centers:
Center for Devices and Radiological Health; Center for Biologics Evaluation and Research
Submission types covered:
Pre-Submission; Submission Issue Request; Study Risk Determination; Informational Meeting
Format requirements:
eCopy
Effective requirement date for eCopy:
January 1, 2013
Final rule date for electronic submissions:
December 13, 2019
Intended audience:
Medical device sponsors and applicants
Scope:
Premarket submissions including IDE, 510(k), PMA, HDE, and De Novo requests
Administrative timeline:
15 calendar days acceptance review; meeting scheduling prior to day 75
Year:
2005
Issuing Organization:
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Division of Immunology and Hematology Devices
Document Type:
Guidance Document
Target Audience:
Industry and FDA Staff
Subject:
AFP-L3% Immunological Test Systems, In Vitro Diagnostic Devices, Class II Special Controls
Date Issued:
October 4, 2005
Contact:
Donna Roscoe, [email protected]
Note:
, 301-796-6183
Year:
2023
Region / City:
Duke University
Theme:
Medical Device Regulation
Document Type:
Instructional Document
Organization / Institution:
Duke Office of Regulatory Affairs and Quality
Author:
Duke University
Target Audience:
Medical device developers, regulatory affairs professionals
Period of validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.
Note:
Year
Topic:
Health, Pharmaceuticals
Document Type:
Informational Resource
Organization / Institution:
U.S. Food and Drug Administration
Target Audience:
Consumers, Healthcare Providers, Information Professionals, Researchers
Year:
2025
Region / city:
Massachusetts
Subject:
Tobacco product sales regulations
Document type:
Guidance Document
Organization / institution:
Massachusetts Association of Health Boards
Author:
Cheryl Sbarra, Esq., Executive Director and Senior Staff Attorney, Massachusetts Association of Health Boards; Christohper Banthin, Esq., Program Manager, Public Health Advocacy Institute; Lisa Stevens-Goodnight, Esq., Tobacco Control Director, Massachusetts Municipal Association; Sarah McColgan, Tobacco Control Director, Massachusetts Health Officers Association
Target audience:
Tobacco retailers and permit applicants
Effective period:
2025
Approval date:
12.30.25
Date of changes:
N/A
Year:
2021
Region / city:
United States
Topic:
Drug and Biologic Submission Forms
Document Type:
Regulatory Document
Organization:
U.S. Food and Drug Administration (FDA)
Author:
Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER)
Target Audience:
Pharmaceutical industry professionals, regulatory submission staff
Effective Period:
2021 and onwards
Approval Date:
Not specified
Modification Date:
Not specified
Date:
December 1, 2025 - January 27, 2026
Region / city:
USA
Topic:
Research oversight, FDA guidance updates
Document type:
Regulatory update
Institution:
FDA
Target audience:
Research professionals, oversight committees, investigators, research organizations
Period of validity:
December 1, 2025 - January 27, 2026
Approval date:
December 1, 2025
Modification date:
January 27, 2026
Year:
2018
Jurisdiction:
Rwanda
Document type:
Regulation
Governing body:
Rwanda Food and Drugs Authority (Rwanda FDA)
Approval date:
09/02/2018
Revision date:
11/08/2025
Version:
1
Scope:
Processed food products and related items
Articles:
64
Chapters:
7
Regulated activities:
Manufacturing, licensing, inspection, import/export, registration, promotion, advertisement
Applicable standards:
GMP, GSP, GDP
Year:
Not specified
Region / City:
Not specified
Topic:
Clinical research documentation
Document type:
Standard Operating Procedure
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Study Investigators, Study Coordinators, Regulatory Affairs, Sponsors
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified