№ lp_1_2_50796
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Character count: 15579
File size: 86 KB
Contractual agreement defining roles, responsibilities and regulatory obligations of sponsor, manufacturer and importer for investigational medicinal products used in clinical trials.
Document type:
Quality Technical Agreement
Subject:
Manufacture, overlabelling, importation, release and distribution of investigational medicinal products
Applicable regulations:
GMP, GDP, Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), ICH Good Clinical Practice, Declaration of Helsinki 1996
Parties:
Sponsor Organisation; Manufacturing Organisation; Importing Organisation
Geographic scope:
Great Britain
Intended use:
Clinical trials
Term:
Up to five years from final signature
Review frequency:
Every five years
Annexes:
Drug products and services; Responsibilities of each Party; Key Contact Persons; List of Subcontractors; Technical Agreement Approval; Version History
Providing organisation:
The Newcastle upon Tyne Hospitals NHS Foundation Trust Quality Assurance Pharmacy Team
Source type:
Contractual regulatory document governing quality responsibilities in clinical research supply chains
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2019
Region / City:
New Zealand
Subject:
Plant protection
Document type:
Notification
Agency / Organization:
Ministry for Primary Industries
Author:
N/A
Target audience:
All trading partners
Period of validity:
N/A
Date of approval:
25/01/2019
Date of amendments:
N/A
Year:
2016
Region / city:
South Africa
Topic:
Animal import regulations
Document type:
Information document
Organization / institution:
Directorate Veterinary Services
Author:
Directorate Animal Health
Target audience:
Pet owners, animal importers, veterinary professionals
Period of validity:
Indefinite
Approval date:
12/04/2016
Date of last update:
12/04/2016
Context:
Provides guidelines for the importation of dogs and cats into South Africa, including health requirements, quarantine regulations, and necessary documentation.
Year:
2020
Region / City:
Hawaii
Topic:
Animal Importation, Research Permits, Animal Behavior
Document Type:
Official Request
Agency / Institution:
Hawaii Department of Agriculture
Author:
Lise Madson
Target Audience:
Advisory Committee on Plants and Animals, Research Community
Period of Action:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Context:
Request for the importation of a Vasa parrot for research on animal cognition and behavior, with a focus on Tellington Touch methods for rehabilitation and research in avian species.
Year:
20__
Region / city:
Makati City, Philippines
Theme:
Importation of used vehicles
Document type:
Application form
Organization / institution:
Fair Trade Enforcement Bureau
Author:
Not specified
Target audience:
Importers of used vehicles
Period of validity:
Not specified
Date of approval:
Not specified
Date of amendments:
Not specified
Year:
2020
Region / City:
New Zealand
Subject:
Plant protection
Document type:
Import health standard
Responsible agency:
Ministry for Primary Industries
Notifying member:
New Zealand
Target audience:
Importers of nursery stock
Entry into force:
22 July 2020
International standard reference:
ISPM No. 13, International Plant Protection Convention
Contact authority:
National Notification Authority, National Enquiry Point
Contact details:
Mrs Sally Jennings, Coordinator, SPS New Zealand, PO Box 2526, Wellington, New Zealand, Tel: +(644) 894 0431, Fax: +(644) 894 0733, E-mail: [email protected]
, Website:
https://www.mpi.govt.nz/importing/overview/access-and-trade-into-new-zealand/world-trade-organization-notifications/
Available documents:
Full text available from National Notification Authority and National Enquiry Point
Invoice Number:
………………………………
Declaration Number:
………………………………
Competent Authority:
………………………………
Consignment Description:
………………………………
Embarkation Place:
………………………………
Date of Embarkation:
………………………………
Transporter Identification:
………………………………
Destination Place and Emirate:
………………………………
Harvest/Processing Date Confirmation:
Before 11 March 2011
Origin Prefecture Confirmation:
Not from restricted prefectures
Compliance Assessment:
Ingredients meet UAE requirements
Authorized Representative:
………………………………
Date of Declaration:
………………………………
Year:
2022
Region / City:
United States, Pennsylvania
Subject:
Public health and animal importation
Document type:
Official letter
Organization:
Centers for Disease Control and Prevention
Author:
Christopher Braden, MD
Recipient:
Lisa Jones-Engel, Ph.D
Purpose:
Guidance on nonhuman primate importation and incident response
Incident date:
January 21, 2022
Quarantine duration:
31 days
Species involved:
Cynomolgus macaques
Number of animals:
100
Outcome:
Three macaques euthanized, 97 survived
Health monitoring:
Tuberculosis testing and zoonotic disease surveillance
Regulatory reference:
42 CFR part 71.53
Year:
2017
Regulation:
EU No 536/2014
Document type:
Template
Topic:
Investigational Medicinal Products (IMP)
Regulatory reference:
Article 62(1) of Regulation (EU) No 536/2014
Manufacturer:
Not specified
Certification authority:
Qualified Person (QP)
Target audience:
Manufacturers, sponsors, regulatory bodies
Purpose:
Harmonisation of batch release certification
Approval date:
Not specified
Modification date:
Not specified
Context:
Template for certification of investigational medicinal products batch release for clinical trials, ensuring compliance with EU regulations on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Year:
2023
Region / city:
EU
Topic:
Medical Device Safety
Document Type:
Checklist
Organization:
European Commission
Author:
European Commission
Target Audience:
Medical device manufacturers
Effective Period:
Ongoing
Approval Date:
2023
Revision Date:
Not specified
Year:
2016
Region / city:
EU
Theme:
Pharmaceutical Regulation
Document Type:
Guideline
Organization:
EFPIA
Author:
Sini Eskola
Target audience:
Regulatory authorities, pharmaceutical professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Note:
Year
Document type:
Accountability log
Scope:
Clinical investigation site
Subject matter:
Investigational medical devices
Regulatory framework:
EU Regulation 2017/745 on Medical Devices (MDR)
Applicable date:
26 May 2021
Version date:
18 August 2021
Responsible organization:
Kliniska Studier Sverige
Responsible network:
National network for clinical investigations with medical devices within Clinical Studies Sweden
Geographical context:
Sweden
Intended setting:
Clinical investigation site(s)
Signatory role:
Principal Investigator
Source category:
Clinical research documentation
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.
Year:
2023
Region / City:
Portland
Topic:
Clinical Research
Document Type:
Form
Author:
VA Portland Health Care System
Target Audience:
Researchers, Investigators, IRB Members
Period of Action:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Global
Subject:
Clinical trials, Teletrial Model, Investigational Medicinal Product
Document Type:
Standard Operating Procedure (SOP)
Institution:
Teletrial Primary Site Pharmacy
Author:
Not specified
Target Audience:
Clinical trial staff, Teletrial site personnel
Period of validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2019
Region / city:
EU
Theme:
Clinical trials, Genetic modification
Document type:
Application form
Organization / institution:
European Union
Author:
Not specified
Target audience:
Regulatory authorities, developers of medicinal products
Validity period:
Not specified
Approval date:
October 2019
Amendment date:
December 2020
Year:
2023
Region / City:
United States
Topic:
Clinical trials, Regulatory documentation
Document type:
Checklist
Organization / Institution:
NIMH
Author:
NIMH
Target Audience:
Principal Investigators, study team members
Period of validity:
Ongoing
Approval Date:
Not specified
Date of changes:
Not specified