№ lp_1_2_41286
File format: docx
Character count: 3520
File size: 23 KB
The document provides guidance on the implementation of new requirements and regulatory changes for high-risk implantable and cardiac invasive medical devices in first-in-human clinical trials, as reviewed by the TGA.
Year:
2024
Region / city:
Australia
Theme:
Medical devices, Clinical trials
Document type:
Guidance
Institution:
Therapeutic Goods Administration (TGA)
Target audience:
Clinical trial sponsors, Medical device manufacturers
Effective period:
From 20 March 2024
Approval date:
14 March 2024
Changes date:
14 March 2024
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2019
Region / City:
Wales
Topic:
Medical procedures, End-of-life care, ICD deactivation
Document type:
Operational document
Organization / Institution:
NHS Wales
Author:
Not specified
Target Audience:
Healthcare professionals, Patients, Carers
Period of validity:
Not specified
Approval date:
February 2019
Date of amendments:
Not specified
Note:
Date of change
Type of service:
Remote monitoring
Clinical Category:
Support List (DI)
Procedure Type:
Type C
New item 11736:
Implanted loop recording via remote monitoring
New item 11737:
Implanted electrocardiogram loop recording via remote monitoring
MBS fee:
$36.75
Benefit:
75% = $27.56, 85% = $31.24
Overview:
Introduction of new Medicare Benefits Schedule (MBS) items for remote monitoring of cardiac implantable loop recorder devices, effective 1 November 2022.
Year:
2023
Region / City:
Not specified
Subject:
Cardiovascular implantable electronic devices, MRI
Document Type:
Form
Organization / Institution:
OHI
Author:
Not specified
Target Audience:
Medical professionals, healthcare providers
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Year
Region / city:
Canberra
Subject:
Anticoagulant medicines, High-Risk Medicines
Document type:
Procedure
Organization / institution:
Canberra Health Services
Target audience:
Health professionals involved in prescribing, dispensing, and administering anticoagulants
Context:
This document provides guidelines on the safe management of high-risk anticoagulant medicines in Canberra Health Services to prevent prescription, dispensing, and administration errors.
Note:
Year
Region / city:
Canberra
Topic:
High-Risk Medicines, Insulin Administration
Document Type:
Procedure
Institution:
Canberra Health Services
Target Audience:
CHS Employees (Medical, Nursing, Midwifery, Pharmacy, Allied Health)
Year:
2023
Region / City:
Victoria
Subject:
Medication Safety, High-Risk Medicines
Document Type:
Guidance
Organization:
Victorian Department of Health
Author:
eHealth High Risk Medicine Safety Advisory Group
Target Audience:
Healthcare professionals, Clinical staff
Period of validity:
Ongoing
Approval Date:
2023
Date of Changes:
None
Year:
Not specified
Region / City:
Australia
Topic:
Health, Safety, Environment
Document Type:
Framework / Policy Guidance
Organization:
Telstra
Audience:
Suppliers of services and high-risk products
Scope:
Suppliers of services and high-risk products to Telstra
References:
Telstra HSE Standards, AS/NZ 3745
Attachments:
Definitions (Attachment 1)
Requirements:
Legal and contractual obligations of suppliers, mandatory HSE elements including Asbestos, Gas Detection, Special Work Locations, Electromagnetic Energy
Emergency Planning:
Compliance with AS/NZ 3745 for facilities management
Monitoring:
Managed and reviewed by Telstra designated contact, network induction mandatory for suppliers and visitors
Risk Management:
Includes hazard identification, inspections, risk assessment, and control measures
Environmental Considerations:
Energy impact, recycling, waste management, visual and flora/fauna protection
Note:
Year
Subject:
Travel and safety regulations
Document Type:
Waiver Application
Organization / Institution:
University of Connecticut
Target Audience:
University students participating in travel programs
Document type:
Emergency rescue plan
Scope:
High-risk work activities
Related high-risk work:
Confined space entry; use of safety harness; excavation and trenching; energised fault finding
Emergency phone numbers:
000; 112; (07) 3270 4040
Country:
Australia
Region:
Queensland
Emergency communication:
Phone; radio channel (if applicable)
Rescue scenarios:
Engulfment; falls; hazardous atmosphere; hazardous chemicals; fire; electrical
Required rescue equipment:
Harness; first aid kit; breathing apparatus; rescue lines; stretchers; oxygen resuscitation equipment; tripod or davit; lighting; firefighting equipment; gas detector; defibrillator; ventilation equipment; crane
Participants:
Rescue party members; spotters; qualified rescuers
Preconditions:
Rescue equipment set up and tested prior to work; briefing completed before commencement
Intended audience:
Workers and rescue personnel involved in high-risk work
Year:
2021
Region / city:
Australia
Theme:
Biosecurity
Document type:
Regulatory list
Organization / institution:
Australian Government Department of Agriculture, Water and the Environment
Target audience:
Importers and stakeholders in agriculture and biosecurity
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Note:
Year
Contextual description:
A research paper providing advanced imaging analysis methods for refining risk assessment in high-risk neuroblastoma patients.
Document Type:
Category 1 submission for Authority Required (Written) listing
Medicine:
Eflornithine (Ifinwil®) 250 mg tablet
Active Ingredient:
Eflornithine (as hydrochloride)
Sponsor:
Norgine Pty Ltd
Regulatory Authority:
Therapeutic Goods Administration (TGA)
Advisory Body:
Pharmaceutical Benefits Advisory Committee (PBAC)
Program:
Section 100 – Highly Specialised Drugs Program
Schedule:
General Schedule (Code GE – Schedule 85)
Indication:
High-risk neuroblastoma in patients aged 1 year and older in remission after prior therapy
Population:
Patients ≥1 year with high-risk neuroblastoma meeting INRG, COG, or SIOPEN criteria
Treatment Phase:
Initial and Continuing Treatment
Comparator:
Standard of care (follow-up and monitoring)
Clinical Outcomes:
Event-free survival, overall survival, safety
Dosage Form:
250 mg oral tablet
Treatment Duration:
Up to 27 cycles (2 years) or until disease progression
Orphan Drug Designation:
Granted 7 December 2022
Submission Pathway:
TGA/PBAC Parallel Process
Restriction Type:
Authority Required (Full assessment – written)
Prescriber Type:
Medical Practitioners (paediatric oncologist or haematologist for initiation)
Year:
2023
Region / City:
N/A
Subject:
Medical Research
Document Type:
Research Supplementary Figures
Institution:
N/A
Author:
N/A
Target Audience:
Medical Professionals
Action Period:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Context:
A set of supplementary figures for a study on the risk of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs) based on high-risk threshold values of hs-CRP and LDL-C, categorizing patients by these values and analyzing survival outcomes.
Year:
2026
Region:
United States
Subject:
Obstetric care, community birth
Document Type:
Clinical guideline
Issuing Organization:
Oregon Health Authority
Author:
Health Evidence Review Commission (HERC)
Target Audience:
Healthcare providers, midwives, obstetricians
Scope:
Prenatal, intrapartum, and postpartum care for low-risk pregnancies
High-Risk Conditions:
Detailed list of maternal, fetal, and pregnancy conditions requiring hospital transfer or consultation
Reference:
HERC Coverage Guidance
Year:
2026
Organization / Department:
UTM Campus PMO
Document Type:
Project Charter
Intended Audience:
Project Managers, Sponsors, Project Owners, Executives
Project ID:
Provided by PMO
Project Name:
[Enter name of project]
Project Sponsor:
[Name], [Position], [Department]
Project Owner:
[Name], [Position], [Department]
Project Manager:
[Name], [Position], [Department]
Version:
1.0
Date of Approval:
[Insert Date]
Revision History:
0.1–1.0
Budget:
[Enter estimated budget]
Scope:
High-complexity or high-risk project implementation
Deliverables:
Defined project outputs including transition plans, communication plans, and lessons learned register
Milestones:
Key project phases and expected completion dates
Key Stakeholders:
Project Sponsor, Project Manager, Project Owner, Project Team members