№ lp_1_2_43601
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This document provides instructions and requirements for submitting a cover letter when transitioning clinical trials from Directive 2001/20/EC to Regulation (EU) No 536/2014, listing necessary changes and document approval information.
Year:
2023
Region / City:
European Union
Topic:
Clinical Trials, Medical Regulation
Document Type:
Cover Letter
Organization:
European Commission
Author:
European Commission
Target Audience:
Pharmaceutical Companies, Clinical Trial Sponsors
Action Period:
Transition of Clinical Trials from Directive 2001/20/EC to Regulation (EU) No 536/2014
Approval Date:
N/A
Amendment Date:
N/A
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Document type:
Regulatory guidance
Regulatory framework:
Directive 2001/20/EC; Regulation (EU) No 536/2014
Subject:
Transition of clinical trials from CTD to CTR
Applicable documents:
Protocol; Investigator’s Brochure; Investigational Medicinal Product Dossier
Regulatory authorities involved:
National Competent Authorities; Ethics Committees
Geographical scope:
European Union Member States
Related systems:
CTIS; EudraCT
Intended user:
Sponsor of multinational clinical trials
Referenced guidance:
EudraLex Volume 10; CTCG Best Practice Guide; European Commission Q&A
Document status:
Informational requirements for transition applications
Scope of changes addressed:
Non-substantial changes; harmonised and consolidated documents; auxiliary medicinal products; IMPD-Q submissions
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).
Document type:
Regulatory guidance
Regulatory framework:
Directive 2001/20/EC; Regulation (EU) No 536/2014
Subject:
Transition of clinical trials from CTD to CTR
Applicable documents:
Protocol; Investigator’s Brochure; Investigational Medicinal Product Dossier
Regulatory authorities involved:
National Competent Authorities; Ethics Committees
Geographical scope:
European Union Member States
Related systems:
CTIS; EudraCT
Intended user:
Sponsor of multinational clinical trials
Referenced guidance:
EudraLex Volume 10; CTCG Best Practice Guide; European Commission Q&A
Document status:
Informational requirements for transition applications
Scope of changes addressed:
Non-substantial changes; harmonised and consolidated documents; auxiliary medicinal products; IMPD-Q submissions
Year:
2022
Region / City:
Not specified
Subject:
Nuclear safety, regulatory compliance
Document Type:
Technical Guide
Organization:
Office for Nuclear Regulation (ONR)
Author:
Nuclear Equivalence Inspector
Target Audience:
ONR inspectors, licensees
Period of Validity:
Until Dec-2025
Approval Date:
Dec-2022
Revision Date:
Not specified
Document Reference:
NS-INSP-GD-012
Record Reference No.:
2022/72622
Year:
2017-2020
Region / City:
Ballymount, Dublin
Theme:
Waste Management
Document Type:
Application Form
Organization:
Circol ELT Ltd
Author:
Circol ELT Ltd
Target Audience:
Waste collectors, companies seeking registration
Period of validity:
2017-2020
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Country:
Australia
Type of document:
Application form
Issuing authority:
Therapeutic Goods Administration (TGA)
Intended audience:
Medical practitioners
Purpose:
Application to become an authorised prescriber of unapproved medicines or medical devices
Regulatory reference:
Therapeutic Goods Regulations 1990, Regulation 12B(1B)
Required attachments:
Ethics committee or specialist college approval/declaration (if applicable)
Information collected:
Personal details of medical practitioner, patient consent, product information, prescribing details
Submission method:
Email or fax to TGA
Year:
2024
Region / City:
European Union
Topic:
Vehicle Authorization, Regulatory Changes
Document Type:
Notification Form
Agency:
European Union Agency for Railways
Author:
European Commission
Target Audience:
Entities managing vehicle authorization changes
Period of Validity:
From 1 October 2024
Approval Date:
Not specified
Date of Changes:
1 October 2024
Context:
A notification form used by entities to inform the European Union Agency for Railways about changes to an already authorized vehicle, following regulatory guidelines and requirements for new authorizations under EU regulations.
Year:
2015
Type of document:
Assessment report template
Subject:
Pharmacovigilance, Periodic Safety Update Reports (PSUR)
Organization:
European Medicines Agency (EMA)
Target audience:
Lead Member States, MAHs, PRAC members
Procedure number:
Not specified
Data lock point:
Not specified
Status:
Guidance and procedural template
References:
GVP Module V, VII, VIII; Variations Classification guideline Commission Regulation 1234/2008; HMA/EMEA recommendations EMEA/743133/2009
Year:
2023
Region / City:
United Kingdom
Subject:
Medical treatment, Court of Protection
Document Type:
Practice Guidance
Institution:
Court of Protection
Author:
Mr Justice Hayden
Target Audience:
Legal professionals, healthcare providers, commissioners of clinical services
Period of Validity:
Until superseded by revised MCA Code
Approval Date:
Not specified
Date of Amendments:
Not specified
Effective date:
1 August 2006
Document type:
Administrative mandate
Sector:
General Ophthalmic Services
Regulatory framework:
GOS Terms of Service
Subject:
Authorised signatories for GOS1 forms
Jurisdiction:
United Kingdom
Signatory requirements:
Practitioner and Contractor signatures under specified circumstances
Scope:
Financial and regulatory responsibilities for GOS claims
Supersedes:
All previous practice mandates
Change procedure:
New mandate required for any change in signatories
Note:
Date
Year:
2020
Region / City:
Australia
Topic:
Paramedicine
Document Type:
Template
Organization / Institution:
Paramedicine Board of Australia
Author:
Paramedicine Board of Australia
Target Audience:
Paramedics required to undertake supervised practice
Effective Date:
27 November 2020
Period of Supervision:
Varies based on individual plan
Date of Approval:
27 November 2020
Date of Changes:
Not specified
Institution:
University of West London
Department:
Compliance Team
Document Type:
Administrative form
Subject:
Authorised absence during term time
Applicable To:
Student Visa holders
Regulatory Framework:
UK Visas and Immigration regulations
Maximum Approved Period:
Two weeks
Required Evidence:
Documentary evidence (UK registered medical practitioner for health issues)
Approval Process:
Personal Tutor or Course Leader signature and Compliance Team approval
Submission Method:
Email to [email protected]
Related Authority:
UK Border Agency
Note:
Year
Topic:
Gas market settlement
Document type:
Form
Agency / Institution:
AEMO