№ files_lp_4_process_3_139969
File format: docx
Character count: 424
File size: 649 KB
Summary of workshop discussions and practices regarding quality risk management in pharmaceutical development and the product lifecycle.
Year:
2026
Region / City:
International
Topic:
Quality Risk Management in Pharmaceuticals
Document Type:
Workshop Overview
Organization / Institution:
ICH
Author:
Not specified
Intended Audience:
Pharmaceutical professionals and quality managers
Related Guidelines:
ICH Q9, ICH Q10
Content Focus:
Risk assessment, risk control, risk communication, risk review, managing subjectivity and bias, use of data and knowledge
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.
Document type:
Regulatory guidance
Subject:
Pharmacovigilance reporting
Regulatory framework:
ICH E2F
Scope:
Clinical trials of investigational medicinal products
Reporting obligation:
Annual safety reporting
Intended recipients:
Regulatory authorities, ethics committees, sponsors
Key entities referenced:
Medicines and Healthcare Products Regulatory Agency (MHRA)
Covered document sections:
Executive summary, safety actions, cumulative exposure, adverse event reporting
Confidentiality status:
Contains confidential and unblinded safety data
Applies to:
Non-commercial sponsors
Year:
2016
Region / city:
Not specified
Subject:
Clinical trial regulations, GCP compliance
Document type:
Checklist
Institution:
Not specified
Author:
Not specified
Target audience:
Investigators, trial staff
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Document type:
Regulatory guidance
Subject area:
Nonclinical pharmacology summaries
CTD module:
Module 2.6.3
Standard referenced:
ICH M4S — The CTD Safety
Submission format:
eCTD
Regulatory framework:
Common Technical Document
Issuing organizations referenced:
International Council for Harmonisation, U.S. Food and Drug Administration
Referenced guidance dates:
August 2001
Content elements:
Primary pharmacodynamics, secondary pharmacodynamics, safety pharmacology, pharmacodynamic drug interactions
Technical requirements:
INN usage, GLP compliance identification, study numbering, CTD location referencing
Source type:
Guidance with annotated sample tables
Note:
Year
Subject:
Intangible Cultural Heritage (ICH)
Document Type:
Questionnaire
Target Audience:
Communities involved in ICH practices, researchers, organizations
Contextual description:
A model questionnaire for identifying elements of intangible cultural heritage when creating inventories.
Note:
Year
Contextual Description:
International ethical and scientific standards for conducting clinical trials with human subjects, outlining compliance with ICH-GCP Guidelines and additional requirements for NYU’s HRPP.
Year:
2024
Region / City:
Paris
Theme:
Disaster Risk Reduction, Intangible Cultural Heritage
Document Type:
Lesson Plan
Organization:
UNESCO
Author:
UNESCO
Target Audience:
Stakeholders involved in the inventorying, safeguarding, and mobilization of intangible cultural heritage in disaster contexts
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2026
Region:
European Union / Non-EU agencies
Subject:
Pharmaceutical quality assessment
Document type:
Regulatory submission form
Organization:
European Medicines Agency
Author:
Not specified
Target audience:
Regulatory affairs professionals
Period covered:
Not specified
Date issued:
2026
Reference standard:
ICH Common Technical Document
Subject Area:
Clinical research regulation
Document Type:
Regulatory document review worksheet
Related Standards:
ICH GCP Guidelines; 45 CFR 46; 21 CFR 50; 21 CFR 312
Institution / Authority Referenced:
Division of Microbiology and Infectious Diseases (DMID)
Regulatory Authority Referenced:
U.S. Food and Drug Administration (FDA)
Ethics Oversight Reference:
Office for Human Research Protections (OHRP)
Purpose:
Guidance for completion, review, and maintenance of essential regulatory documents for clinical trials
Document Structure:
Tier-based classification of regulatory documents with section and page references
Document Tiers:
Tier 1A; Tier 1B; Tier 2; Closeout Documents
Key Forms Referenced:
Form FDA 1572; Investigator of Record Form; Financial Disclosure Form
Key Roles Referenced:
Principal Investigator; Sub-Investigator; Clinical Site Monitor
Oversight Bodies Referenced:
Institutional Review Board (IRB); OHRP
Applicable Study Types:
DMID-supported IND and IDE clinical studies
Primary Users:
Site staff conducting DMID supported studies; clinical site monitors; DMID contractors
Core Documentation Covered:
Investigator credentials, IRB approvals, informed consent documentation, laboratory certifications, regulatory compliance records
Compliance Focus:
Verification of adherence to Good Clinical Practice and applicable federal regulations
Year:
2012–2021
Region / City:
Washington State, USA
Document Type:
Membership roster
Organization:
SACH (State Advisory Council on Homelessness), ICH (Interagency Council on Homelessness)
Positions Included:
Local Government Representatives, Non-Profit Representatives, Housing Authority Representative, Philanthropic Representative, Federal Government Representative, Homeless Person Representatives, Business Representative, ICH Agency Representatives, Youth Representative
Appointments:
Various dates 2012–2017
Expirations:
Various dates 2018–2021
Contact Information:
Included for each member and agency representative
Affiliated Agencies:
Kitsap County Department of Human Services, Washington State Coalition Against Domestic Violence, Okanogan County Community Action Council, Lower Columbia Community Action Program, Kennewick Housing Authority, Campion Foundation, U.S. Department of Housing and Urban Development, Department of Commerce, DSHS divisions, Employment Security Department, Department of Veterans Affairs, Health Care Authority, Office of Superintendent of Public Instruction, State Board of Community and Technical Colleges, Department of Corrections, Governor’s Executive Policy Office
Purpose:
Lists appointed members and agency representatives with roles, contact details, and term information
Year:
Not specified
Region / City:
Not specified
Subject:
Laboratory biosafety
Document Type:
Manual
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Laboratory personnel, safety officers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Not specified
Topic:
Stakeholder Engagement and Information Disclosure
Document Type:
Guidance
Organization / Institution:
World Bank
Author:
Not specified
Target Audience:
Project developers, environmental and social experts, stakeholders involved in project preparation
Period of validity:
Not specified
Approval Date:
November 2023
Date of Changes:
Not specified
Year:
2017
Region / City:
Nevada
Topic:
Legal Document Requirements
Document Type:
Legal Notice
Organization / Institution:
County Recorder
Author:
Nevada Revised Statutes
Target Audience:
Individuals or entities submitting real property documents for recording
Period of Action:
Ongoing (from October 1, 2017)
Approval Date:
October 1, 2017
Date of Changes:
N/A
Year:
Not specified
Region / city:
Not specified
Topic:
Biblical studies, Life of Jesus
Document type:
Lesson plan / Bible study guide
Author:
Not specified
Target audience:
Students or Bible study participants
Scripture references:
John 19, Isaiah 53, Psalm 22, Psalm 34, Psalm 51, Psalm 69, Zechariah 12, Exodus 12, Leviticus 14, Numbers 19, Hebrews 9, Ephesians 1, 1 John 1
Purpose:
To understand the fulfillment of prophecies in the life and death of Jesus and explore the theological significance of his crucifixion and resurrection
Year:
2024
Region / City:
Vienna, Austria
Subject:
Environmental Product Declarations, Life Cycle Assessment
Document Type:
Product Category Rules (PCR)
Organization / Institution:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target Audience:
Stakeholders in the environmental product declaration process, including manufacturers and environmental professionals
Period of Validity:
Not specified
Approval Date:
2024-01-24
Date of Changes:
2024-10-10
Year:
2024
Region / City:
Vienna, Austria
Theme:
Environmental Product Declarations (EPD) for Drywall Systems
Document Type:
Product Category Rules (PCR)
Organization / Institution:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target Audience:
Manufacturers and stakeholders in the building industry
Validity Period:
Ongoing, updates as per EPD review and revisions
Approval Date:
2024-10-10
Date of Changes:
2024-10-10
Year:
2016
Region / City:
Not specified
Subject:
Video Surveillance Systems
Document Type:
Product Guide Specification
Standard:
CSI 3-Part Format, MasterFormat 2016
Manufacturer:
ZHEJIANG DAHUA VISION TECHNOLOGY CO., LTD.
Address:
No.1399, Binxing Road, Binjiang District, Hangzhou, P.R. China
Postal Code:
310053
Telephone:
+86-571-87688888 28933188
Email:
[email protected]
Website:
www.dahuasecurity.com
Warranty:
3 years for replacement and repair
Installer Experience Requirement:
Minimum 5 years
Manufacturer Experience Requirement:
Minimum 10 years
Supported Video Features:
Face detection, vehicle detection, perimeter protection, construction monitoring
Camera Resolution:
Up to 1920×1080
Power Supply:
12 VDC, 5 A ± 10%
Operating Temperature:
–20 °C to +55 °C
Protection Rating:
IP66, surge and lightning protection
Intelligence Type:
WizMind
Year:
2026
Region:
South East London, UK
Topic:
Prescribing and Shared Care Policy
Document Type:
Official Letter Template
Organization:
South East London Integrated Medicines Optimisation Committee (SEL IMOC)
Target Audience:
General Practitioners, Hospital Pharmacists
Applicable Period:
Current prescribing and shared care arrangements
Reference:
SEL Interface Policy, EL (95)5
URL:
http://www.selondonjointmedicinesformulary.nhs.uk/default.asp
Year:
2023
Region / city:
Vienna, Austria
Theme:
Environmental Product Declaration, Concrete and Concrete Elements
Document type:
Technical specification
Organization:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target audience:
Environmental professionals, construction industry stakeholders
Validity period:
2023-05-30 onwards
Approval date:
2023-05-30
Date of revisions:
2018-06-13, 2019-07-06, 2020-11-05, 2021-01-12, 2021-04-07, 2021-08-27, 2021-11-27, 2023-01-27, 2023-05-30
Scope:
Concrete, Precast concrete parts
Relevant standards:
EN 15804, ISO 14025, ÖNORM EN 206, ÖNORM B 4710-1, ÖNORM EN 13369
Type of LCA calculation:
Specific for Concrete and Concrete Elements
LCA standards:
EN 15804+A2, EN 16757
Publishing institution:
Bau EPD GmbH
Declaration holder:
To be determined by Bau EPD GmbH
Accreditation mark:
ECO Platform
Description:
Technical document outlining the requirements for creating Environmental Product Declarations (EPDs) for concrete and concrete elements, based on ISO 14025 and EN 15804 standards.
Date:
2023-09-20
Region / City:
Austria, Vienna
Topic:
Environmental Product Declarations for Drywall Systems
Document Type:
Standards and Guidelines
Organization:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target Audience:
Industry professionals, manufacturers, environmental consultants
Period of Validity:
Not specified
Date of Approval:
2023-09-20
Date of Changes:
2023-09-20
Year:
2023
Region / city:
Vienna, Austria
Theme:
Environmental Product Declarations, Construction Clay Products
Document Type:
Guidelines
Organ / Institution:
Bau EPD GmbH
Author:
Bau EPD GmbH
Target audience:
Companies and professionals in the construction industry
Validity Period:
Not specified
Approval Date:
2023-09-20
Date of Changes:
2023-09-20