№ lp_1_2_11660
File format: docx
Character count: 70185
File size: 106 KB
Year:
2016
Region / city:
Europe
Topic:
Good Manufacturing Practice for Advanced Therapy Medicinal Products
Document type:
Consultation response
Organization / institution:
EBE/EFPIA
Author:
EBE/EFPIA
Target audience:
Pharmaceutical industry, Regulatory authorities
Period of validity:
Indefinite
Approval date:
28-Jun-2016
Modification date:
N/A
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / city:
United Kingdom
Topic:
Good Manufacturing Practice, Advanced Therapy Medicinal Products (ATMPs)
Document type:
Consultation response
Organization / institution:
NHS Advanced Therapy Medicinal Products Working Party
Author:
Anne Black
Target audience:
Pharmaceutical professionals, regulatory bodies, academic researchers
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2024
Region / City:
European Union
Theme:
Health Technology Assessment
Document Type:
Guidance Document
Author:
HTA Coordination Group (HTACG)
Target Audience:
Health Technology Developers, Regulatory Authorities, Medical Researchers
Period of Validity:
Ongoing
Approval Date:
28 November 2024
Date of Last Change:
N/A
Context:
Guidance document for filling in the joint clinical assessment (JCA) dossier template for medicinal products, intended for use by health technology developers and regulatory bodies.
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).
Note:
Year
Theme:
Medicinal product registration
Document type:
Application form
Organization:
Swissmedic
Target audience:
Pharmaceutical companies, Regulatory authorities
Year:
Not specified
Jurisdiction:
South Africa
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Document type:
Regulatory validation checklist
Document format:
eCTD
Subject area:
Medicinal product variations
Product type:
Human medicinal products
Application type:
Variation application
Intended submitter:
Holder of certificate of registration
Submission scope:
Administrative, technical, and business validation
Regulatory modules referenced:
CTD Modules 1–5
Use context:
Initial and follow-up eCTD sequences
Approval status fields:
Included
Language:
English
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:
Quality Technical Agreement
Year:
2022
Region / City:
European Union
Theme:
Orphan medicinal products, market exclusivity
Document type:
Template
Organization:
European Medicines Agency
Author:
CMDh
Target Audience:
Applicants for marketing authorization of orphan medicinal products
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
July 2022
Note:
Region / City
Document Type:
Validation Checklist
Contextual description:
A validation checklist for medicinal product applications within the Decentralized Procedure (DCP) process.
Year:
2024
Region / city:
EU
Subject:
Health Technology Assessment
Document type:
Annex
Organization:
HTA CG
Author:
European Commission
Target audience:
Health Technology Assessment bodies, regulatory bodies
Effective period:
October 2024
Approval date:
28 November 2024
Modification date:
None
Year:
2025
Region / city:
Switzerland
Theme:
Medicinal product authorisation
Document type:
Regulatory submission form
Organisation / institution:
Swissmedic
Author:
Swissmedic
Target audience:
Pharmaceutical companies
Period of validity:
From 01.10.2025
Approval date:
Pending
Amendment date:
N/A
Year:
2025
Region / City:
Switzerland
Topic:
Medicinal Product Authorisation
Document Type:
Application Form
Institution:
Swissmedic
Author:
Not specified
Target Audience:
Regulatory authorities, Pharmaceutical companies
Period of validity:
From 01.01.2025
Approval Date:
Not specified
Date of Changes:
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:
2024
Region / city:
Europe
Theme:
Health Technology Assessment, Medicinal Products
Document type:
Template
Organization:
European Medicines Agency (EMA), HTACG
Author:
Not specified
Target audience:
Health Technology Developers (HTD), European regulatory bodies
Period of validity:
Not specified
Date of approval:
28 November 2024
Date of revisions:
Not specified
Job Title:
Machinist
Document Number:
JD-22
Department:
Manufacturing
Department Code:
1670
Employment Status:
Non-Exempt
Location:
Martin-Baker America Inc., Johnstown, PA, USA
Reports To:
CNC Supervisor
Direct Reports:
No
Organization:
Martin-Baker America Inc.
Job Purpose:
Setup and independent operation of CNC and conventional machining equipment to produce parts to blueprint dimensions and tolerances
Key Responsibilities:
CNC milling and turning operations, machine setup, programming, inspection coordination, tool and offset management, preventive maintenance participation
Education Required:
High school diploma
Experience Required:
CNC and conventional machine setup and operation; CNC programming
Skills and Competencies:
Critical thinking, communication, results orientation, reliability, GD&T, fixture design, root cause analysis, CMM interpretation
Physical Requirements:
Routine lifting up to 25 pounds; standing, sitting, walking, bending throughout the facility
Work Environment:
Manufacturing areas requiring personal protective equipment
Security Clearance Requirement:
None
Equal Employment Statement:
Commitment to diversity and equal employment opportunity; veteran priority consideration
Year:
2026
Region / city:
United Kingdom
Topic:
Good Manufacturing Practice, Advanced Therapy Medicinal Products (ATMPs)
Document type:
Consultation response
Organization / institution:
NHS Advanced Therapy Medicinal Products Working Party
Author:
Anne Black
Target audience:
Pharmaceutical professionals, regulatory bodies, academic researchers
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2026
Region / City:
Coventry
Industry:
Additive Manufacturing, Engineering
Document Type:
Job Description
Organization:
Manufacturing Technology Centre (MTC)
Author:
Manufacturing Technology Centre
Target Audience:
Potential job applicants
Period of validity:
Indefinite
Approval Date:
N/A
Amendment Date:
N/A
Year:
2025
Region / City:
EAST JAKARTA, DKI JAKARTA
Subject:
Company Data, Corporate Changes, Business Activities
Document Type:
Company Report
Organization:
YAMAHA INDONESIA MOTOR MANUFACTURING
Author:
N/A
Target Audience:
Stakeholders, investors, legal entities
Period of Validity:
Unlimited
Approval Date:
September 25, 2025
Amendment Date:
July 8, 2025
Year:
2025
Country:
United Kingdom
Region:
Ellesmere Port, Cheshire
Site:
Stanlow Manufacturing Complex
Operator:
Essar Oil (UK) Limited
Regulatory framework:
Environmental Permitting Regulations 2016
Directive:
Industrial Emissions Directive
BAT reference:
Refining of Mineral Oil and Gas BAT Conclusions (2014/7/738/EU)
Derogation subject:
BAT Conclusion 52
Derogation period:
Until 31/10/2025
Pollutants covered:
Non-methane volatile organic compounds; Benzene
BAT-AELs referenced:
NMVOC 10 mg/Nm3; Benzene 1 mg/Nm3
Permit type:
Environmental permit variation
Decision status:
Draft
Purpose:
Record of decision-making and consultation considerations
Activities regulated:
Refining mineral oils; Oil movements; Chemical activities; Incineration; Combustion; Waste recovery or disposal; Carbon capture for geological storage
Competent authority role:
Assessment of application and setting of permit conditions
Source type:
Draft regulatory decision document