№ lp_1_2_16444
File format: docx
Character count: 5434
File size: 654 KB
Administrative document outlining requirements, disclosures, and data fields for submitting an abbreviated application for the assessment of medicinal products by the Scottish Medicines Consortium within the NHSScotland framework.
Document type:
Submission form
Subject:
Abbreviated submission of medicinal products
Jurisdiction:
Scotland
Regulatory framework:
Freedom of Information (Scotland) Act 2002
Intended authority:
Scottish Medicines Consortium
Submission format:
Electronic
Confidentiality classification:
Commercial-in-Confidence and Academic-in-Confidence
Applicable sector:
Healthcare and pharmaceuticals
Target submitters:
Pharmaceutical companies
Review scope:
NHSScotland
Date referenced:
September 2024
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
1989
Region / city:
Munich
Subject:
Electrical Engineering
Document Type:
Seminar Paper
Author:
Analog Devices
Target Audience:
Engineers, researchers in electrical power
Approval Date:
1989
Date of Changes:
N/A
Year:
2018
Region / City:
Philadelphia
Subject:
Information Technology, Project Management
Document Type:
Course Description
Organization / Institution:
Community College of Philadelphia
Author:
Barbara Anne Hearn
Target Audience:
Students pursuing a career in IT Project Management
Period of Validity:
Fall 2019 and onward
Approval Date:
November 28, 2018 (updated February 13, 2019)
Date of Changes:
February 13, 2019
Year:
2010
Region / City:
Kumasi
Theme:
Land administration, resettlement
Document type:
Final report
Organization:
Ministry of Lands and Natural Resources (MLNR), Government of Ghana
Author:
Praisel Consulting Limited
Target Audience:
Government agencies, World Bank, stakeholders involved in land administration and resettlement
Effective period:
2010-2011
Approval date:
October 2010
Date of amendments:
Not specified
Year:
1993-1995
Region / City:
California
Theme:
Environmental Science, Communications, Media
Document Type:
Curriculum Vitae
Organization / Institution:
California State University
Author:
Gregory M. Popejoy
Target Audience:
General Public, Academic Professionals
Effective Period:
2008-present
Approval Date:
1/20
Year:
2025
Region / City:
Philadelphia, PA
Field:
Health Studies, Recreational Therapy
Document Type:
CV
Organization / Institution:
Temple University
Author:
Heather R. Porter, PhD, CTRS, FDRT
Target Audience:
Academics, Researchers, Healthcare professionals
Period of Action:
From 1992–Present
Date of Approval:
April 2025
Date of Changes:
N/A
Note:
Year
Theme:
Medical Emergency, CPR, AED
Document Type:
Emergency Response Plan
Organization:
School
Target Audience:
School staff
Non-Emergency Responsibilities:
School nurse
Year:
1989
Region / City:
Munich
Topic:
Analog Design
Document Type:
Seminar Paper
Institution:
Analog Devices GmbH
Author:
Don Lancaster, A. Grütz, H. Huneus
Target Audience:
Electrical Engineers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Date
Faculty:
Faculty of Medicine
Current Affiliations:
Health Authority:
Current Rank:
Since:
Note:
Date
Year:
2018
Region / City:
Lusaka
Subject:
Resettlement Action Plan
Document Type:
Report
Organization:
Ministry of Water Development, Sanitation and Environmental Protection
Author:
Litumelo Mate, Pilila Chongo
Target Audience:
Project Affected Persons, Government Agencies, Stakeholders
Effective Period:
2018
Approval Date:
10-11-2018
Date of Changes:
Not specified
Year:
2023
Region / City:
Not specified
Topic:
Health research, COVID-19 trial
Document Type:
Research report, supplementary material
Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, health professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Document Type:
Institutional Review Board (IRB) checklist
Subject:
Criteria for approval of research involving an abbreviated Investigational Device Exemption (IDE)
Related Document:
HRP-314 - WORKSHEET - Criteria for Approval
Applicable To:
IRB Chairs, Vice Chairs, designees, Research Compliance Administrators
Purpose:
Documentation of regulatory determinations and protocol-specific findings
Scope:
Initial reviews, modifications, and continuing reviews with changed determinations
Responsible Office:
IRB Office
Key Topics:
Significant Risk Device Study; Non-Significant Risk Device Study; Risk determination rationale
Regulatory Basis:
Applicable federal regulations governing investigational device studies
Record Retention:
Maintained in the protocol file
Year:
2026
Region / City:
Nottingham, UK
Subject:
Dry powder inhaler testing, aerodynamic particle size distribution
Document Type:
Research article
Institution:
Copley Scientific Ltd
Authors:
Ben Bradley, Mark Copley
Target Audience:
Scientists and laboratory technicians in pharmaceutical R&D and quality control
Tested Devices:
Symbicort® Turbohaler®
Experimental Methods:
Andersen Cascade Impactor (ACI), Next Generation Impactor (NGI), Fast Screening Andersen (FSA), Fast Screening Impactor (FSI)
Key Variables:
Flow rate rise-time, flow resistance, apparatus volume
Study Purpose:
To match flow rate rise-time profiles of abbreviated and full resolution impactors using a variable volume and flow resistance compensator
Year:
2023
Region / City:
N/A
Subject:
Proposal submission requirements
Document Type:
Instructional
Organization / Institution:
DARPA
Author:
N/A
Target Audience:
Proposers to DARPA
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2026
Region / City:
United States
Topic:
Federal procurement and contract management
Document Type:
Policy/Guidance
Agency / Institution:
GSA (General Services Administration)
Author:
GSA
Target Audience:
Contractors, Government Agencies
Period of Validity:
Ongoing
Approval Date:
N/A
Modification Date:
N/A
Year:
Not specified
Region / City:
Not specified
Topic:
Corporate Experience, Relevant Project Experience
Document Type:
Solicitation Guidelines
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Contractors, Offerors
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
KiwiSaver, default provider, investment mandate, responsible investment
Document type:
Submission template