№ lp_1_2_45071
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This document provides a template for briefing submissions to the CHMP, detailing the structure for product development, scientific advice requests, and regulatory status.
Year:
2026
Region / City:
EU
Theme:
Regulatory Affairs, Pharmaceuticals
Document Type:
Template
Organization:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Pharmaceutical companies, regulatory affairs professionals
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Price: 8 / 10 USD
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Organisation:
European Medicines Agency
Committee:
Committee for Medicinal Products for Human Use
Document type:
Assessment report template and procedural guidance
Procedure scope:
Initial marketing authorisation and EUM4All applications
Geographical scope:
European Union
Language variant:
British English
Intended contributors:
Rapporteurs, Co-Rapporteurs, PRAC Rapporteurs, EMA Procedure Assistants
Regulatory framework:
EU medicines regulatory procedure
Document status:
Living document updated across procedural milestones
Source type:
Regulatory guidance and internal procedural template
Year:
2023
Region / City:
Amsterdam
Subject:
Request for extension of clock stop duration in the centralized marketing authorization process
Document Type:
Request template
Organization / Institution:
European Medicines Agency
Author:
EMA
Target Audience:
Marketing Authorization Holders, Applicants
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Year
Region / city:
Amsterdam
Type of document:
Assessment report
Committee / organization:
Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC)
Procedure number:
EMEA/H/C/
Rapporteurs:
CHMP Rapporteur, PRAC Rapporteur
Product type:
Generic/hybrid medicinal product
Confidential information included:
Yes / No
Organisation:
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Type of document:
Early market engagement briefing
Sector:
Healthcare
Specialty:
Orthopaedics
Geographic scope:
North West England
Location:
Wrightington Hospital, Wigan
Year:
2024
Purpose:
Exploration of partnership opportunities for private orthopaedic patient services
Partnership model:
Strategic multi-phase public–private partnership
Current private provision:
John Charnley Wing
Private patient income:
£6.6 million (2024/25)
Strategic framework:
Wrightington Strategy 2023–2030
Regulatory context:
NHS Foundation Trust
Market focus:
UK private orthopaedic healthcare market
Target partners:
Experienced private healthcare providers
Source type:
Institutional briefing and market engagement material
Year:
2022
Region / City:
RBKC
Subject:
Asset Management, Housing Maintenance
Document Type:
Tender Briefing
Organization:
RBKC Housing Management
Author:
Not specified
Target Audience:
Service Providers
Period of Validity:
Not specified
Approval Date:
May 2022
Date of Revisions:
Not specified
Year:
2025
Region / City:
Brooklyn
Topic:
SAS, Visual Analytics, Skills Transfer
Document Type:
Request for Proposal (RFP)
Organization:
SARS
Author:
SARS
Target Audience:
Service Providers, SAS Experts
Period of Validity:
12 months
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / city:
European Union
Topic:
Pharmaceutical technology development
Document type:
Briefing document
Organization:
European Medicines Agency
Author:
Not specified
Target audience:
Pharmaceutical experts, regulatory authorities
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
This document is a briefing source for discussing pharmaceutical technology and regulatory aspects at a QIG 1:
1 meeting.
Year:
2025
Region / City:
Bath, UK
Subject:
Foreign Influence Registration Scheme
Document Type:
Briefing Note
Institution:
University of Bath
Author:
Unknown
Target Audience:
University staff and students
Effective Period:
From 1 July 2025
Approval Date:
Unknown
Date of Amendments:
Unknown
Year:
2025
Region / City:
Scotland
Topic:
Creative Industries
Document Type:
Sector Report
Organization:
Office of the Chief Economic Adviser
Author:
N/A
Target Audience:
Policymakers, Economists, Business Analysts
Period of Validity:
2025
Approval Date:
11 December 2025
Date of Changes:
N/A
Year:
2025
Region / country:
Global
Theme:
Land acquisition for biodiversity conservation
Document type:
Project proposal briefing
Organization:
IUCN NL
Author:
IUCN NL
Target audience:
Local NGOs, CSOs, environmental conservation organizations
Period of validity:
Until 2025
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2024
Region / City:
United Kingdom
Topic:
Pharmacy Education, Workforce Wellbeing, Leadership Development
Document Type:
Briefing
Institution:
School of Pharmacy and Medicines Optimisation
Author:
Unknown
Target Audience:
Pharmacists, Pharmacy Technicians, Healthcare Scientists, ICB leads, Employers
Period of Validity:
November 2024
Approval Date:
November 2024
Change Date:
None
Year:
2026
Document Type:
Regulatory submission packet
Target Audience:
FDA reviewers, clinical researchers
Scope:
Preclinical and clinical development planning
Therapeutic Area:
Pharmacology / Drug development
Contents:
Introduction, Clinical Background, Regulatory Background, Pharmacology, Clinical Plan, Toxicology, Chemistry, Manufacturing and Controls, Development Plans, FDA Questions, References
Note:
Year
Year:
2024
Organization:
School of Pharmacy and Medicines Optimisation, NHS England
Document type:
Briefing / Newsletter
Target audience:
Trainee pharmacists, pharmacy technicians, independent prescribers, community pharmacy leads
Topics:
Apprenticeships, National Education and Training Survey, independent prescribing supervision, community pharmacy workforce
Period:
October 2024
Key dates:
EOI closing 13 October 2024, NETS survey open until 26 November 2024
Funding:
£15,053 per trainee per year for Community Pharmacy Technician Apprenticeship Programme
Year:
2024
Region / City:
United Kingdom
Subject:
Pharmacy education and workforce development
Document type:
Informational briefing
Organization / Institution:
NHS England
Author:
School of Pharmacy and Medicines Optimisation
Target audience:
Pharmacy professionals, NHS managers, apprentices
Effective period:
September 2024 - ongoing
Approval date:
September 2024
Date of updates:
September 2024
Year:
2024
Region / City:
Scotland
Topic:
National Care Service, healthcare, social care
Document Type:
Briefing
Organization / Institution:
The Health and Social Care Alliance Scotland (the ALLIANCE)
Author:
Not specified
Target Audience:
Not specified
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Appendix 2 Version 2 of Passes Policy Guidelines: Briefing for Security Passes and Permit Applicants
Reference:
KAA/9/50/20 VOL. 34
Document type:
Policy guideline appendix
Subject:
Airport security passes and access permits
Regulatory basis:
KCASRs, 2020 Regulation 62
Issuing authority:
Issuing Authority
Sector:
Aviation security
Geographic scope:
Airport restricted and landside areas
Conditions of use:
Display, access limitations, surrender, and loss reporting
Penalties:
Fine up to KES 500,000, imprisonment up to six months, or both
Applicable personnel:
Airport employees, contractors, visitors, and permit holders
Includes declaration:
Yes
Year:
2020
Region / City:
Denver
Theme:
Environmental Regulation
Document Type:
Briefing Paper
Agency:
National Park Service (NPS) - Denver Service Center (DSC)
Author:
Unknown
Target Audience:
Federal development project planners, environmental compliance officers
Effective Period:
Ongoing
Approval Date:
04-10-2020
Amendment Date:
N/A
Year:
2020-2027
Region / City:
Southern Company Gas
Subject:
DIMP Capital Budget and Pipe Replacements
Document Type:
Proposed Budget Report
Organization / Institution:
Southern Company Gas
Author:
Steven Murphy, Vice President, Engineering & Construction, Southern Company Gas; Donald Carter, Vice President, Compliance & Technical Services, Southern Company Gas
Target Audience:
Stakeholders involved in DIMP program and budget approval
Effective Period:
2020-2027
Approval Date:
2020
Date of Changes:
None provided
Year:
2024
Region / City:
Not specified
Topic:
MHHS Qualification
Document Type:
Qualification Assessment Document
Organization / Institution:
BSC and REC Code Bodies
Author:
Elexon and REC Performance Assurance
Target Audience:
Programme Participants
Effective Period:
2024
Approval Date:
18/09/2024
Modification Date:
29/08/2024