№ files_lp_3_process_7_105207
File format: docx
Character count: 35414
File size: 104 KB
Official meeting minutes documenting the discussions, objectives, and planned actions of an international expert working group on updating guidance for benefit-risk assessment of medicinal products across their full lifecycle.
Year:
2019
Dates:
17–18 September 2019
Location:
Geneva, Switzerland
Venue:
Best Western Chavannes De Bogis, Chemin des Champs-Blancs 70B, 1279 Chavannes-de-Bogis
Document Type:
Meeting minutes
Organising Body:
CIOMS (Council for International Organizations of Medical Sciences)
Working Group:
CIOMS Working Group XII
Subject:
Benefit-risk balance assessment for medicinal products
Related Guidance:
CIOMS IV (published 1998)
Chair:
Lembit Rägo
President (Opening):
Hervé Le Louët
Rapporteur:
Panos Tsintis
Participants:
Representatives from regulatory authorities, industry, academia, and international organizations
Main Topics:
Update of CIOMS IV guidance; qualitative and quantitative benefit-risk assessment; regulatory perspectives; industry perspectives; patient preferences; real-world evidence; post-marketing evaluation; risk communication; lifecycle approach to benefit-risk
Meeting Outcome:
Agreement on objectives, drafting structure, subgroup formation, and planning of future work for new CIOMS XII guidance
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.
Year:
2021
Region / City:
Global
Topic:
Vaccine Benefit-Risk Assessment
Document Type:
Standardized Template
Organization / Institution:
Brighton Collaboration
Author:
Brighton Collaboration Working Groups
Target Audience:
Vaccine developers, regulatory authorities, public health professionals
Period of validity:
Indefinite
Date of approval:
N/A
Date of changes:
N/A
Year:
2022
Organization:
CIOMS (Council for International Organizations of Medical Sciences)
Event Type:
General Assembly meeting
Format:
Virtual meeting
Location:
Online / Virtual
Participants:
Representatives of international medical and pharmacovigilance organizations
Topics:
CIOMS activities during 2021, publications, conferences, working groups, student engagement, website monitoring, proposed budget for 2022
Key Publications:
Clinical Research in Resource-limited Settings (June 2021), Cumulative Pharmacovigilance Glossary
COVID-19 Impact:
All meetings virtual, adaptations to remote work
Awards:
Best Scientific Paper in pharmacovigilance, product development, and research ethics (2021 recipient: Gilbert Lazarus, Indonesia)
Collaborations:
WHO, UNESCO, ICH, Uppsala Monitoring Centre, IFMSA
Financial Overview:
2021 budget performance, proposed 2022 budget, currency considerations (CHF/USD)
Document Type:
Meeting minutes / official record
Year:
2023
Organization:
3rd Generation Partnership Project (3GPP)
Technical Group:
Technical Specification Group Radio Access Network
Document Type:
Technical Specification
Version:
V17V18.30.0
Scope:
Applicability of NGAP messages and procedures to non-3GPP access
References:
3GPP TS 38.413, 3GPP TS 23.501, 3GPP TS 23.502, 3GPP TS 23.316, 3GPP TS 24.502
Trademarks:
UMTS™, 3GPP™, LTE™, GSM®
Access Points:
N3IWF, TNGF, TWIF, W-AGF
Procedures:
PDU Session Management, UE Context Management, Transport of NAS Messages, Interface Management, UE TNLA Binding
Status:
For development purposes only, not approved for implementation
Contextual Description:
Technical specification detailing the NGAP message procedures and their application to various non-3GPP access network nodes in the 5G system.
Year:
2026
Dates:
January 17–18, 2026
Biblical Text:
2 Corinthians 8:6–9 (ESV)
Series:
2 Corinthians
Week:
36
Message Number:
26-03
Preacher:
Dr. Mike Fabarez
Church:
Compass Bible Church
Document Type:
Sermon outline and study guide
Associated Ministry:
Focal Point
Related Format:
Audio and video sermon
Included Sections:
Sermon outline, Application Questions, Related Sermons, Recommended Reading, Daily Bible Reading Schedule
Contact Information:
[email protected]
Note:
; (949) 540-0699
Primary Themes:
Christian generosity, grace, love, stewardship, spiritual growth
Sermon outline and study guide presenting exposition of 2 Corinthians 8:
6–9 with application questions, related resources, and a coordinated Bible reading schedule for congregational study.
Year:
2025
Dates of session:
17–18 September 2025
Place:
Brussels
Institution:
European Economic and Social Committee
Session number:
599th plenary session
Document type:
Annex to official minutes
Event:
End-of-Mandate Ceremony
Main themes:
Social Europe; competitiveness and sustainability; youth participation; civil society; EU enlargement
Key initiatives mentioned:
Youth Test; Youth Advisory Council
Participants:
Members of the European Economic and Social Committee; representatives of EU institutions; social partners; civil society; Enlargement Candidate Members
Geographical scope:
European Union and enlargement candidate countries
Year:
2023
Event dates:
17–18 June 2023
Document date:
15 February 2023
Event name:
FARR 1020 National Championships
Document type:
Notice of Race
Organising authority:
Bucklands Beach Yacht Club
Venue:
Bucklands Beach Yacht Club, 21 Ara-Tai, Half Moon Bay, Auckland 2012
Racing area:
Vicinity of Northern Leading Light, bounded by Rangitoto Island, Browns Island and Bean Rock
Class:
Farr 1020
Divisions:
Open; Non-spinnaker
Number of races:
Up to 7 races
Minimum races for series:
5 races
Entry fee:
$100 (late fee additional $75)
Eligibility requirements:
Financial membership of recognised club; current membership of Farr 1020 Class Owners’ Association
Insurance requirement:
Marine third-party liability insurance with minimum cover of $5,000,000 per incident
Prizes:
National Championship title and places; handicap prizes
National Race Officer:
Hamish Tait
Contact email:
[email protected]
Governing rules:
The Racing Rules of Sailing; YNZ Safety Regulations Part II Category 4; Farr 1020 Class Rules
Date:
17 June 2025
Event:
Exercise Blyth
Type of document:
Observer programme
Subject:
Offshore renewables emergency response exercise
Organising body:
HM Coastguard, Maritime and Coastguard Agency
Coordinating body:
Offshore Renewable Energy Emergency Forum
Exercise director:
Pete Lowson
Location:
Offshore locations and coordination centres in the United Kingdom
Time zone:
British Summer Time (BST) / UTC+1
Related event:
Exercise Sancho (2022)
Participants:
HM Coastguard, Ocean Winds, Police Scotland, Esvagt, emergency services and industry partners
Format:
Virtual session via Microsoft Teams
Contact:
[email protected]
Note:
/ +44 (0) 7772 352612
Audience:
International industry representatives and emergency services observers
Event:
The University of Hong Kong Centenary Celebrations Presidents Summit – East Meets West
Dates:
December 17–18, 2011
Location:
Hong Kong
Organizer:
The University of Hong Kong
Document type:
Participant list
Arrangement:
Alphabetical order
Participants:
University presidents, vice-chancellors, rectors, provosts, vice-presidents, and senior administrators
Institutions represented:
Universities and higher education institutions from Asia, Europe, North America, and Australia
Related documents:
Seating Plan for Opening, Panel Discussion and Conclusion
Year:
2025
Country:
New Zealand
Region / City:
Not specified
Facility:
Home of St Barnabas
Legal Entity:
Home of St Barnabas Trust
Type of Document:
Surveillance audit report
Audit Standard:
Ngā paerewa Health and disability services standard (NZS8134:2021)
Auditing Agency:
BSI Group New Zealand Ltd
Supervising Authority:
Manatū Hauora (Ministry of Health)
Legislation:
Health and Disability Services (Safety) Act 2001
Services Audited:
Rest home care (excluding dementia care)
Audit Start Date:
17 December 2025
Audit End Date:
18 December 2025
Beds Occupied at Time of Audit:
36
Maximum Capacity:
41 residents
Sections of Standard Assessed:
Ō tātou motika; Hunga mahi me te hanganga; Ngā huarahi ki te oranga; Te aro ki te tangata me te taiao haumaru; Te kaupare pokenga me te kaitiakitanga patu huakita; Here taratahi
Audit Scope:
Review of policies and procedures, resident and staff files, observations, and interviews with residents, family/whānau, staff, general practitioner, and management
Governance Structure:
Board of trustees with general manager and care management team
Key Finding Areas:
resident rights, governance and workforce structure, care planning, medication management, quality and risk systems
Surveillance audit report documenting compliance assessment of Home of St Barnabas rest home services against the Ngā paerewa Health and disability services standard (NZS8134:
2021) during an on-site evaluation conducted in December 2025.
Year:
2014
Region / School:
St Peters Middle School, Queensland, Australia
Event type:
Portfolio Conference and Art Exhibition
Target audience:
Parents of Middle School students
Dates:
17–18 September 2014
Location:
PAC (Performing Arts Centre)
Coordinators:
Mr Wayne Gauld, Ms Joanne Pearn
Specialist teachers involved:
Jenny Flottmann, Tim Stoll, Evelin Cutts, Wes Meurant, Julie Zhu, Sylvia Sanjurjo, Anne Tetley-Jones, Peter Dawson, Kerry Schreiber, Melissa Young, Renata Rankin, Katherine Austin, Fiona Dagott, Jo Belchamber
Purpose:
Sharing student learning progress and showcasing selected student artworks
Communication method:
Email contact for specialist teachers and online feedback survey