Presentation: Conformity assessment evidenceTGA Australia
An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
Presentation: Conformity assessment evidenceTGA Australia
An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
Presentation: Spotlight on prescription medicines reformsTGA Australia
An overview of initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines as well as orphan drugs and developments for eCTD and the new MedSearch app.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Online Clinical Trial Notification (CTN)TGA Australia
This presentation provides a brief background on the TGA's role in the regulation of clinical trials as well as guidance on using the new online Clinical Trial Notification form
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The presentation outlines how the TGA’s new priority review pathway for prescription medicines works and how medicines might be deemed to be a priority for Australian patients. We discuss how the provisional approval pathway contributes to early access and how to judge when early data seems promising.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
Presentation: Spotlight on prescription medicines reformsTGA Australia
An overview of initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines as well as orphan drugs and developments for eCTD and the new MedSearch app.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
Online Clinical Trial Notification (CTN)TGA Australia
This presentation provides a brief background on the TGA's role in the regulation of clinical trials as well as guidance on using the new online Clinical Trial Notification form
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The presentation outlines how the TGA’s new priority review pathway for prescription medicines works and how medicines might be deemed to be a priority for Australian patients. We discuss how the provisional approval pathway contributes to early access and how to judge when early data seems promising.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
Q1 Medical Devices Regulation - practical consequences for manufacturersErik Vollebregt
Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry
The world of Regulatory convergence: an Australian reflectionTGA Australia
This presentation provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods.
Presentation: Device vigilance - local challenges & global trendsTGA Australia
This session will examine some of the hot topic in this areas including a presentation from TGA covering some of the challenges they are seeing locally as well as an industry perspective on global hot topics and trends in device vigilance
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
This presentation on AFAO's submission regarding rapid testing and the TGA Review of Medicines and Devices Regulation was given by Ben Wilcock, AFAO Health promotion Officer, at the AFAO Members Forum – May 2015.
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Similar to Presentation: Spotlight on medical device MMDR reforms (20)
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Presentation Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TG...TGA Australia
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Presentation: Spotlight on medical device MMDR reforms
1. Spotlight on Medical Device MMDR Reforms
Dr Cheryl McRae
Assistant Secretary
Medical Devices Branch, TGA
2017 ARCS Annual Conference
August, 2017
2. Expert Panel Review (MMDR)
• Two reports released during 2015
– Medicines and Devices
– Complementary medicines and Advertising
• Review included discussion papers, submissions and interviews,
followed by stakeholder workshops and other meetings
• Department considered feedback and advised Minister, who took
preferred position to Cabinet
• Government intent released in May 2016 budget - full response
released on 15 September 2016
– Government accepted 56 of the 58 Recommendations
Spotlight on Medical Device MMDR Reforms
1
3. Overarching principles for regulation
As endorsed by Government
• The Australian Government retains responsibility for approving
the inclusion of therapeutic goods in the ARTG
– Rather than automatically accepting international approvals
– However need to make much greater use of overseas evaluations
• Need to introduce greater flexibility in approval pathways
• TGA could more appropriately align level of regulation with the
actual risk posed by the products in certain areas
Spotlight on Medical Device MMDR Reforms
2
4. MMDR medical device projects
• Key projects
• Designation of conformity assessment bodies in Australia
• Expedited review process for certain ‘novel’ devices
• Use of approvals from comparable overseas regulators
• Harmonisation with the European Union
• Strengthening of post market monitoring
Spotlight on Medical Device MMDR Reforms 3
5. MMDR medical device projects
Other relevant projects
• Further reviews - including review of the range of low-risk devices included in the ARTG
• TGA advisory committees – includes new Advisory Committee on Medical Devices
Related projects
• Simplified and more effective regulation of advertising
• Streamlined regulation of Patient-Specific Access
• SME regulatory assistance
Spotlight on Medical Device MMDR Reforms 4
6. Designation of conformity assessment bodies
Implementation scheduled for January 2018
• Legislative change in progress:
– Therapeutic Goods Amendment (2016 Measures No 1) Act 2017) – Royal Assent 19 June 2017
– Further legislative change in a further Bill for passage in the Spring 2017 sittings
– Regulations also required
• Key processes being designed:
– TGA as designating authority - Roles and responsibilities, composition, structure, cost recovery and
competitive neutrality
– Conformity assessment bodies - Roles and responsibilities, requirements and market potential
– Designation process - Framework and criteria
Spotlight on Medical Device MMDR Reforms
5
7. Designation of conformity assessment bodies
Implementation will be complex
• Few commercial conformity assessment bodies
currently exist in Australia.
• Is the market big enough to justify setting up Australian
notified bodies?
• Cost and logistics for TGA in being a designating
authority as well as a conformity assessment body.
• Flow on impacts of competitive neutrality requirements
for TGA conformity assessment.
Spotlight on Medical Device MMDR Reforms
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8. Expedited review process - certain ‘novel’ devices
Implementation scheduled for January 2018
• Legislation in place (regulations also required)
• ‘Front of queue’ approach with normal assessment requirements
– Must still comply with EPs, conformity assessment procedures, etc.
– Compliance with Clinical Evidence Guidelines critical for fast assessment
• Reason for accelerated assessment would be based on health outcomes:
– prevents, diagnoses or treats a life threatening or seriously debilitating disease or condition
– addresses an unmet clinical need
– breakthrough technology
Spotlight on Medical Device MMDR Reforms
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9. Expedited review process - certain ‘novel’ devices
Implementation will be complex
• Need to define strict criteria to warrant expedited evaluation
– Will be similar, but not identical, to US FDA criteria
include devices that can ‘prevent diseases and conditions’
include ‘seriously debilitating’ rather than ‘irreversibly debilitating’ conditions
• Designation process will be under 6 weeks
– eligible sponsor must submit application within 3 months
• Impacts on other assessments need to be managed
• Rejection by a foreign regulator and failure to continue meeting
eligibility criteria can result in loss of status
Spotlight on Medical Device MMDR Reforms
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10. Comparable overseas regulators
Implementation scheduled for January 2018
• Legislation and regulations required
– Legislative change in MMDR Bill for passage in the Spring 2017 sittings
• Consultation closed 30 June 2017
– Submissions being considered (17 received)
• Proposed criteria:
– Scope
– Operational alignment
– IMDRF member
– Life cycle approach
– Communication and cooperation
– Expertise
Spotlight on Medical Device MMDR Reforms
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11. Comparable overseas regulators
Implementation will be complex
• International device regulations different to Australia
• Comparable overseas regulators will need to be identified
• Regulations undergoing significant change in Europe
• Sponsors need to provide submissions and evaluation
reports to TGA
Spotlight on Medical Device MMDR Reforms
10
12. Harmonisation with Europe
New European regulations came into effect from 25 May 2017
• MMDR Recommendation 20 accepted by Government:
“The regulation of medical devices by the Australian NRA is, wherever possible, aligned with the European
Union framework…Should the Australian NRA seek to apply specific requirements, there must be a clear
rationale to do so.”
• Consultation has recently commenced on two specific aspects (closes 25 August 2017):
– Up-classification of surgical mesh from Class IIb to Class III
– Requirement for patient medical device ID cards (patient implant cards)
Aim to be in place by end of 2017 (with transition aligned with Europe)
• Further consultations on harmonisation with Europe will be released in 2018
Spotlight on Medical Device MMDR Reforms
11
13. Post market monitoring recommendations
• Better integration and timely analysis of available datasets
• Electronic reporting of adverse events
• Enhanced information-sharing with overseas regulators
• Implementation of registries for all high risk implantable devices
Accepted by Government
Deferred
Spotlight on Medical Device MMDR Reforms
12
14. Post market monitoring
Enhanced Post Market Monitoring and Analytics (EPMMA)
• TGA has embarked on a project aimed at establishing
enhanced post market monitoring and analytics
– has already delivered enhanced analytics for medical devices
• The next stages in the project will deliver:
– electronic data interchange (EDI) for reporting of medical device incident
reports
– improved TGA adverse event report management systems (AEMS).
Spotlight on Medical Device MMDR Reforms
13
15. Post market monitoring
Electronic Data Interchange (EDI)
• Currently, details of adverse events and incidents are
manually entered in an online TGA form (via the TGA’s
Business Services portal).
• EDI will enable sponsors (and other users) to submit the
required information directly from their own information
management / investigation systems.
• Expected to be launched early 2018.
Spotlight on Medical Device MMDR Reforms
14
16. Low risk product review
Consultation closed May 2017 – over 1000 submissions
• Part of review includes Class I medical devices:
– does not recommend changing the current Australian classification system for
medical devices
– no specific products have been singled out under this review
• Proposed next steps
– Systematic review of ARTG to identify non therapeutic goods
– Engage with States and Territories Health department procurement branches
– Update the Excluded Goods Order
– Review the Class I medical device ARTG entry process
Spotlight on Medical Device MMDR Reforms
15