№ files_lp_3_process_7_052982
File format: docx
Character count: 9956
File size: 42 KB
Year:
2023
Region / City:
Europe
Topic:
Pharmaceutical Regulation
Document Type:
Position Paper
Organization / Institution:
EFPIA (European Federation of Pharmaceutical Industries and Associations)
Author:
EFPIA
Target Audience:
Regulatory authorities, pharmaceutical industry stakeholders
Effective Period:
Ongoing evaluation
Approval Date:
Not specified
Amendment Date:
Not specified
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Date:
26/06/2020
Version:
Final
Reference:
PA/PH/Exp. MG/T (19) 23 ANP
Year:
2020
Region / City:
Europe
Topic:
Nitrosamine impurities in pharmaceutical substances
Document type:
Response to a proposal
Organization / Institution:
EFPIA
Author:
EFPIA
Target audience:
Regulatory bodies, pharmaceutical industry professionals
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2015
Organization:
EFPIA
Author:
Pär Tellner
Document type:
Consultation feedback
Region:
European Union
Target audience:
CMDh, National Competent Authorities, pharmaceutical industry
Period covered:
up to 2020
Date submitted:
27 November 2015
Communication method:
Electronic submission, Word format
Date:
12 May 2025
Document Number:
EMA/152360/2016 rev.1
Modules:
2.5, 2.7.1, 2.7.2, 2.7.3, 2.7.4, 5.3.x.x
Type:
Regulatory submission template
Purpose:
Clinical overview, biopharmaceutical studies, clinical pharmacology, efficacy, safety, CSR body, CSR appendices
Applicant/MAH:
Not specified
Regulatory Agency:
European Medicines Agency
Confidentiality Guidance:
Annex 3 of POLICY/0070
Period:
2025
Year:
Not specified
Region / Country:
Not specified
Subject:
Conflicts of Interest and Confidentiality
Document type:
Declaration form
Organization / Institution:
European Medicines Agency (EMA)
Intended audience:
EMA Experts, Patients involved in EMA activities
Sections included:
Personal Details, Declaration of Interests, Confidentiality Undertaking
Time frame for declaration:
Last 3 years and any executive/lead roles in career
Format:
Electronic completion
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
Year:
2025/2026
Region / City:
West Dunbartonshire
Subject:
Education Maintenance Allowance (EMA)
Document Type:
Guide
Organization / Institution:
West Dunbartonshire Council
Author:
West Dunbartonshire Council
Target Audience:
Students eligible for EMA
Validity Period:
2025-2026
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2025
Region / City:
United Kingdom
Topic:
Electromagnetic Activities Research and Development
Document Type:
Prior Information Notice (PIN) Questionnaire
Organization:
Defence Science and Technology Laboratory (Dstl)
Target Audience:
Industry, academia, and suitably qualified experienced personnel (SQEP)
Period of Implementation:
Up to 5 years starting January 2025
Purpose:
Collect market feedback and insights for future EMA S&T research collaboration and development
Focus Areas:
Integration and synchronisation of EMA, Generation after Next (GAN) Electromagnetic Attack capabilities
Governance:
Leadership Team from Dstl and supplier, Consultation Group, Delivery Group
Scope:
TRL 1-6, primarily TRL 1-4 research taskings
Collaboration Model:
EMA Accelerator (EMAA) with end-to-end task management and industry/academic involvement
Year:
2019
Subject:
Nitrosamine risk assessment in pharmaceutical excipients
Document type:
Questionnaire and technical guidance
Regulatory reference:
European Medicines Agency nitrosamine review requirement
Related document:
Information on nitrosamines for marketing authorization holders (EMA/189634/2019)
Note:
Related document
Questions and answers on Information on nitrosamines for marketing authorization holders (EMA/CHMP/428592/2019 Rev. 1)
Industry sector:
Pharmaceutical manufacturing
Scope:
Evaluation of nitrosamine formation risks in excipient manufacturing processes
Prepared for:
Drug product manufacturers and Marketing Authorization Holders
Intended respondents:
Excipient suppliers and manufacturers
Regulatory authorities referenced:
European Medicines Agency, Health Canada, Therapeutic Goods Administration (Australia), Swissmedic
Key substances addressed:
Nitrites, nitrates, nitrosamines, secondary and tertiary amines
Manufacturing aspects covered:
Raw materials, intermediates, reagents, catalysts, solvents, water purification, recycled solvents, multipurpose equipment
Supporting content:
Guidance on nitrosating agents, amine sources, contamination risks, acceptable intake determination, and purge assessment principles
Year:
2017
Region / City:
N/A
Theme:
Medical Device Regulation
Document Type:
Fee List
Organization / Institution:
Notified Body XXXX
Target Audience:
Manufacturers of medical devices
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2024
Region / City:
Glen Rose, Texas
Topic:
Probate Fees
Document Type:
Notice
Organization / Institution:
Somervell County Clerk
Author:
Michelle Reynolds, County Clerk
Target Audience:
General public, legal professionals
Period of validity:
From 1/1/2024
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2025
Region / City:
Singapore
Topic:
Customs, Inter-Bank GIRO, Payment Procedures
Document Type:
Application Form
Agency / Organization:
Singapore Customs
Author:
Singapore Customs
Target Audience:
Entities with business transactions involving Singapore Customs
Effective Period:
Ongoing
Approval Date:
Not stated
Date of Amendments:
Not stated
Year:
2012
Region / City:
United States
Topic:
Corporate Social Responsibility, Audit Fees, Audit Opinions
Document Type:
Academic Paper
Institution:
George Mason University, City University of Hong Kong, The Chinese University of Hong Kong, The University of Tennessee
Authors:
Long Chen, Bin Srinidhi, Albert Tsang, Wei Yu
Target Audience:
Academics, Researchers, Auditors, Policymakers
Period of Effectiveness:
2000-2008
Approval Date:
March 30, 2012
Date of Amendments:
N/A
Court:
United States Bankruptcy Court
District:
Western District of Missouri
Document type:
Motion
Case type:
Bankruptcy
Governing rule:
Local Rule 2016-2(E)
Moving party:
Attorney for the debtor(s)
Debtor(s):
Enter debtor(s) name
Case number:
Enter Case No.
Fee categories:
Defense of motions for relief from the automatic stay; defense of motion to dismiss for failure to make plan payments; motions to suspend or abate payments; motion to vacate and reinstate following dismissal for default in plan payments; hearings; copy expenses; postage expenses
Response period:
Twenty-one (21) days from the date of notice
Filing method:
Electronic filing via ECF or mail
Court address for responses:
United States Bankruptcy Court, 400 E. 9th St., Room 1510, Kansas City, MO 64106
Certification:
Certificate of Service included
Year:
2022
Region / City:
SADC region
Topic:
Medicine Regulatory Harmonization
Document Type:
Position Paper
Organization / Institution:
SADC Medicines Regulatory Forum (SADC MRF)
Author:
T. Sithole, G. Mahlangu, S. Walker, S. Salek
Target Audience:
Regulatory authorities, pharmaceutical industry, applicants
Period of Validity:
Up to 12 months from issuance of recommendation
Date of Approval:
Not specified
Date of Amendments:
Not specified
Form Reference:
SC-A-020 (Ver 13 – 07/22)
Date:
DD/MM/YYYY
Note:
Unique Entity Number
Singapore Customs’ Bank Account Number:
001-038761-8
Processing Time:
up to 4 weeks
IBG Termination:
Bank directly
Fee for Unsuccessful IBG Deduction:
Penalty may apply
Contact Email:
[email protected]
Year:
2017
Region / city:
Kenya
Theme:
Land Registration
Document type:
Application Form
Institution:
Land Registry
Author:
Unknown
Target audience:
Applicants for land registration
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2023
Region / City:
United States
Subject:
Property Preservation Requirements and Fees for VA-Guaranteed Loans
Document Type:
Regulatory Requirements
Organization / Institution:
U.S. Department of Veterans Affairs
Author:
Not specified
Target Audience:
Loan Servicers, Property Inspectors, Real Estate Professionals
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2025
Region / City:
Rogers, Arkansas
Subject:
Development Impact Fees
Document Type:
Ordinance
Organization / Institution:
Rogers City Council
Author:
Rogers Waterworks and Sewer Commission
Target Audience:
City officials, developers, residents
Period of validity:
From October 1, 2025
Approval Date:
July 22, 2025
Date of amendments:
June 16, 2025