№ lp_1_2_20168
File format: docx
Character count: 11340
File size: 2097 KB
Regulatory guidance outlining required supporting documents, record management practices, and inspection points applied during document-based conformity inspections of non-clinical studies for medical device approval applications in Japan.
Prepared by:
Office of Non-clinical and Clinical Compliance, Pharmaceutical and Medical Devices Agency
Organization:
Pharmaceutical and Medical Devices Agency
Country:
Japan
Date of preparation:
January 26, 2017
Version:
1.0
Subject area:
Medical devices regulation
Topic:
Non-clinical studies
Document type:
Regulatory guidance
Inspection type:
Document-based conformity inspection
Legal basis:
Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
Target materials:
Supporting data and documents for approval applications
Scope:
Non-clinical studies of medical devices
Intended users:
Applicants for medical device approval and inspection personnel
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Guiding Question:
How did President Roosevelt and his New Deal programs try to ease the economic hardships of the Depression for many, but not all, Americans?
Time Period:
1930s
Historical Context:
Great Depression
Geographic Focus:
United States
Type of Document:
Educational document-based writing activity
Primary Sources Included:
Letters, photograph, radio address excerpt
Programs Referenced:
Home Owner’s Loan Corporation; Civilian Conservation Corps; Works Progress Administration; federal migrant camps
Key Themes:
Government relief; economic recovery; public works; discrimination; unequal distribution of aid
Intended Audience:
Students
Tasks:
Document analysis; note-taking; analytical writing
Writing Assignment:
Two analytical paragraphs using evidence from documents
Skills Emphasized:
Source analysis; perspective comparison; evidence-based writing
Year:
1215
Region:
England
Theme:
Political History / Legal Documents
Document Type:
Educational Worksheet / Historical Text
Institution:
Freshman Global Studies Program
Author:
Roger B. Beck et al. (adapted)
Target Audience:
High school students
Historical Period:
Reign of King John (1199–1216)
Primary Source:
Magna Carta text excerpts
Topics Covered:
Feudal law, liberties of free men, limits on royal authority, legal protections, taxation rules
Note:
Year
Topic:
Regulatory compliance, human subject research
Document type:
Checklist
Organization / Institution:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Year:
2023
Note:
Region / City
Topic:
Research Protocol
Document Type:
Template
Organization / Institution:
DF/HCC
Target Audience:
Investigators, Research Institutions
Note:
Year
Year:
2020
Region / city:
Colorado
Topic:
Behavioral Health
Document Type:
Award Nomination
Organization / Institution:
Colorado Behavioral Healthcare Council (CBHC)
Author:
CBHC
Target Audience:
Community Behavioral Health Organizations
Period of Validity:
Until award announcement
Approval Date:
2020
Date of Changes:
N/A
Year:
2026
Region / City:
Bedford, Luton
Theme:
Healthcare, Sexual Health, Substance Use
Document Type:
Freedom of Information Request
Organization / Institution:
Bedfordshire Hospitals NHS Foundation Trust
Author:
FOI Officer
Target Audience:
Healthcare professionals, policy makers, and researchers
Period of Action:
Not specified
Approval Date:
02/02/2026
Date of Changes:
None
Year:
2023
Region / City:
Ireland
Theme:
Digital Mental Health and Wellbeing Programmes
Document Type:
Referral Form
Organization / Institution:
ISPCC
Author:
ISPCC
Target Audience:
Non-clinical referrers (parents, carers, and teachers)
Effective Period:
Ongoing
Approval Date:
Not specified
Revision Date:
Not specified
Note:
Contextual Description
Year:
2026
Organization:
NHS Professionals
Type of document:
Request Form
Target audience:
Hospital and Trust staff
Location:
United Kingdom
Departments:
Various wards and care groups
Required approvals:
Finance Manager verification, Non-Clinical Consultant review
Fields included:
Contact details, placement dates, hours, working pattern, staff number, system knowledge, assignment code, job description attachment, CV review, interview requirement, DBS requirement
Purpose:
Requesting non-clinical staff placement
Program Name:
Click or tap here to enter text
Year:
2025
Organization:
American Physical Therapy Association (APTA)
Document Type:
Faculty Qualifications Chart
Target Audience:
Program administrators and faculty members
Last Updated:
07/07/2025
Contact:
[email protected]
Instructions Included:
Yes
Data Fields:
Faculty Name, Academic Credentials, Certifications/Memberships, Program Responsibilities, Qualifications, Mentor Qualifications, Professional Development
Year:
2024
Region / City:
N/A
Subject:
Dream research, semantic analysis
Document Type:
Research Protocol
Organization / Institution:
DREAMSEMANTICS.ORG
Author:
N/A
Target Audience:
Researchers, professionals in psychology and dream studies
Effective Period:
N/A
Approval Date:
27 December 2024
Date of Changes:
N/A
Year:
2002
Region / City:
Manchester
Topic:
Safety, Hazard Assessment, Chemical Risk
Document Type:
Risk Assessment Guidelines
Organization / Institution:
University of Manchester
Author:
Not specified
Target Audience:
Safety Officers, Laboratory Managers, Researchers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Region / City:
Pinal County, Arizona
Subject:
Public hearing, variance application
Document type:
Public notice
Organ / institution:
Pinal County Development Services Department
Author:
Pinal County Development Services Department
Target audience:
Residents of Pinal County
Period of validity:
Not specified
Approval date:
December 29, 2025
Amendment date:
Not specified
Context:
Public notice related to a variance application for a land use case in unincorporated Pinal County, Arizona, for the purpose of reducing the minimum required lot area.
Year:
2021
Region / City:
Philippines
Topic:
Recovery Plans
Document Type:
Guidance Paper
Organization / Institution:
Bangko Sentral ng Pilipinas (BSP)
Author:
World Bank
Target Audience:
BSP Bank Supervisors
Period of Application:
April 2021
Approval Date:
8 April 2021
Date of Changes:
-
Year:
2025
Region / City:
Oskaloosa, Iowa
Theme:
Public Works, City Planning
Document Type:
Agenda Memo
Institution:
City Council
Author:
Sean Murphy
Target Audience:
City Council Members, Public Works Department
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2024
Region / city:
Monaco
Topic:
Environmental protection, radioactive substances, marine environment
Document type:
Terms of Reference
Organ / institution:
OSPAR Radioactive Substances Committee (RSC)
Author:
OSPAR
Target audience:
Contracting Parties, Observers, Environmental professionals
Period of validity:
2024–2026
Approval date:
February 2024
Modification date:
Not specified
Note:
Year
Topic:
Health and Safety, Construction Design and Management
Document Type:
Guidance
Target Audience:
Land managers, Designers, Contractors
Year:
2017
Region / City:
California
Subject:
Energy, Distributed Energy Resources, Rulemaking
Document Type:
Rulemaking Order
Issuing Authority:
Public Utilities Commission of the State of California
Target Audience:
Utility companies, regulatory bodies, stakeholders in the energy sector
Period of Effect:
Ongoing
Approval Date:
July 13, 2017
Amendment Date:
None