№ lp_1_20283
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Character count: 25505
File size: 363 KB
The document is a detailed post-market clinical follow-up plan for a medical device, outlining the methods and procedures for ensuring the ongoing safety and performance monitoring of the device after its market release.
Year:
YYYY
Region / City:
[City/Region]
Topic:
Medical Device Safety and Performance Monitoring
Document Type:
PMCF Plan
Organization:
[Manufacturer Name]
Author:
[Author Name]
Target Audience:
Regulatory Authorities, Medical Device Manufacturers
Validity Period:
YYYY/MM/DD to YYYY/MM/DD
Approval Date:
DD/MM/YYYY
Revision Date:
XXXX
Date of Changes:
YYYY/MM/DD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
XXXX
Region / city:
XXXX
Topic:
Medical Device Safety and Performance Evaluation
Document Type:
Evaluation Report
Organization / Institution:
XXXX
Author:
XXXX
Target Audience:
Regulatory Bodies, Medical Device Manufacturers
Period of Effectiveness:
XXXX
Approval Date:
XXXX
Date of Changes:
XXXX
Year:
2015
Region / city:
International
Topic:
Medical Device Regulation
Document Type:
Official Report
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
National Competent Authority Report Working Group
Target Audience:
Medical Device Regulators, Public Health Authorities
Period of validity:
Ongoing
Approval Date:
26 March 2015
Date of amendments:
None
Year:
2016-2017
Region / city:
Australia
Topic:
Life Saving Drugs Program, Rare Diseases, Health Policy
Document type:
Government Report
Organization / institution:
Australian Government
Author:
Australian Government
Target audience:
Health policymakers, healthcare professionals, stakeholders in rare disease treatment
Period of validity:
Ongoing
Date of approval:
2014-04-09
Date of amendments:
None
Year:
2023
Region / City:
Australia
Subject:
Smoking cessation, pharmaceutical benefits
Document Type:
Report
Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Unknown
Target Audience:
Healthcare providers, policymakers
Period of Effect:
Ongoing
Approval Date:
Unknown
Date of Changes:
Unknown
Year:
2021
Region / City:
Australia
Topic:
Smoking cessation, medicines cost-effectiveness, Pharmaceutical Benefits Scheme
Document type:
Report
Organization:
Pharmaceutical Benefits Advisory Committee
Author:
Centre for Health Economics, Monash University
Target audience:
Health professionals, policy makers, Pharmaceutical Benefits Advisory Committee members
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Purpose:
Post-market review, cost-effectiveness evaluation
Clinical issue:
Smoking cessation treatment
Proposed changes to PBS restrictions:
Yes
Market size:
Pharmacological assisted quit attempts
Treatment costs and co-payments:
Yes
Market growth:
Change in quit attempts
Health outcomes:
Quit rates, relapse rates, smoking-related diseases
References:
Yes
Note:
Contextual description
Year:
2023
Region / City:
Australia
Topic:
Opioid Dependence Treatment, Pharmaceutical Benefits Scheme
Document Type:
Government Report
Organization:
Australian Government Department of Health and Aged Care
Author:
Australian Government Department of Health and Aged Care
Target Audience:
Stakeholders, policymakers, healthcare providers, public
Effective Period:
2023-07-01 and onwards
Approval Date:
2023-03-01
Modification Date:
N/A
Interim Review Outcomes Date:
2023-03-01
Note:
Contextual Description
Year:
2019
Region / Country:
Australia
Subject:
Pulmonary arterial hypertension medicines and subsidy policy
Document Type:
Policy review agenda item and briefing
Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Program:
Pharmaceutical Benefits Scheme (PBS)
Topic:
Post-Market Review (PMR) of PAH medicines
Medicines Mentioned:
bosentan, ambrisentan, macitentan, sildenafil, tadalafil, iloprost, riociguat, epoprostenol
Medical Classification Referenced:
WHO Functional Class II–IV pulmonary arterial hypertension
Guidelines Referenced:
2015 European Society of Cardiology / European Respiratory Society Guidelines for the diagnosis and treatment of pulmonary hypertension
Stakeholders:
PAH Reference Group, medicine sponsors including Actelion, GlaxoSmithKline, and Pfizer
Regulatory Focus:
Revision of PBS prescribing restrictions and subsidy conditions
Key Policy Changes Considered:
Extension of subsidised monotherapy to WHO Functional Class II patients, updated PAH definition, inclusion of additional WHO Group 1 PAH subtypes, removal of calcium channel blocker trial requirement, strengthened diagnostic role of right heart catheterisation
Consultation Process:
Pre-PBAC consultation with sponsors and reference group
Associated Meetings:
PBAC meetings in November 2018, March 2019, and planned July 2019 review discussion
Related Policy Activity:
Planned stakeholder meeting on PAH combination therapy scheduled for May 2019
Note:
Year
Topic:
Suicide Prevention
Document Type:
Survey
Organization / Institution:
GLS
Target Audience:
Participants of GLS funded training activities
Duration:
6 or 12 months after initial training
Year:
2023
Region / city:
United States
Topic:
Training Evaluation
Document type:
Template
Institution:
Centers for Disease Control and Prevention
Author:
CDC Training and Evaluation Team
Target Audience:
Training developers, evaluators, and learners
Duration:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2024
Region / City:
California
Subject:
Occupational Safety and Health, State Program Evaluation
Document Type:
Report
Institution:
U.S. Department of Labor, Occupational Safety and Health Administration
Author:
U.S. Department of Labor Occupational Safety and Health Administration
Target Audience:
Government agencies, occupational safety professionals
Period of Action:
October 1, 2023 – September 30, 2024
Approval Date:
May 1, 1973
Program Certification Date:
August 19, 1977
Date of Last Revision:
N/A
Year:
2024
Region / City:
Brazil
Subject:
Human Rights
Document Type:
Report
Organization:
Inter-American Commission on Human Rights (IACHR)
Author:
IACHR
Target Audience:
Governments, human rights organizations, international bodies
Effective Period:
2024
Approval Date:
2024
Date of Changes:
Not specified
Year:
2025
Region / city:
European Union
Topic:
Pharmacovigilance, PSUR Follow-Up
Document Type:
Report
Organ / institution:
CMDh
Author:
Lead Member State
Target Audience:
Health authorities, pharmaceutical companies, regulatory bodies
Period of validity:
February 2025 onwards
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
XXXX
Region / city:
XXXX
Topic:
Medical Device Safety and Performance Evaluation
Document Type:
Evaluation Report
Organization / Institution:
XXXX
Author:
XXXX
Target Audience:
Regulatory Bodies, Medical Device Manufacturers
Period of Effectiveness:
XXXX
Approval Date:
XXXX
Date of Changes:
XXXX
Year:
2023
Region / city:
Kasane, Republic of Botswana
Subject:
Safeguarding of Intangible Cultural Heritage
Document Type:
Official Report
Institution:
Intergovernmental Committee for the Safeguarding of the Intangible Cultural Heritage
Author:
Intergovernmental Committee for the Safeguarding of the Intangible Cultural Heritage
Target Audience:
Member States, Relevant Stakeholders
Period of Validity:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2023
Region / City:
Global
Theme:
Racism, Racial Discrimination, Xenophobia
Document Type:
Report
Body / Institution:
United Nations
Author:
Ashwini K.P, Special Rapporteur on contemporary forms of racism, racial discrimination, xenophobia and related intolerance
Target Audience:
Governments, Civil Society, United Nations entities, Academic Institutions, National Human Rights Institutions
Period of Implementation:
2022 - ongoing
Approval Date:
18 October 2023
Date of Last Update:
N/A
Year:
2021
Region / city:
East and North Hertfordshire
Topic:
Pain Management
Document Type:
Patient Information Leaflet
Institution:
East and North Hertfordshire NHS Trust
Author:
Not specified
Target Audience:
Patients seeking pain management follow-up
Period of validity:
9 months
Approval Date:
2021/12/15
Review Date:
2025/01/01
Publication Date:
2021/12/15
Contact Information:
01438 288616
Office Hours:
Monday to Friday, 9am to 4pm
Circumstances for Appointment:
Change in treatment, side effects, pregnancy planning
End of Service:
9 months from initiation of PIFU
Description:
A patient information leaflet detailing the process and conditions for patient-initiated follow-up (PIFU) regarding pain management services.
Year:
2012
Region / City:
Not specified
Subject:
Reimbursements, Symposium Recommendations, Educational Documents, Communication with OHRP
Document Type:
Memo
Organization / Institution:
ACM
Author:
Jo
Target Audience:
Symposium Participants
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Region / City:
Zoetermeer
Topic:
Rail Interoperability, Technical Assistance
Document Type:
Working Document
Organization:
European Union Agency for Railways, Panteia Consortium
Author:
Panteia Consortium
Target Audience:
Public Authorities, Rail Sector Stakeholders
Period of validity:
2020–2021
Approval Date:
1 February 2022
Date of changes:
N/A
Note:
Year
Organization / Institution:
Rehabilitation Services Administration
Target Audience:
Project Director
Note:
Year