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
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
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
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
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 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
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
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
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: 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
Complying with Wearable Health Device RegulationTGA Australia
Complying with Wearable Health Device Regulation
• Which devices does the TGA regulate?
• How are devices approved?
• How does the TGA regulate devices once they are on the market?
Presentation: Conformity assessment evidenceTGA Australia
An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.
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
Presentation: Recall of Therapeutic GoodsTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
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: 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.
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: 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
Complying with Wearable Health Device RegulationTGA Australia
Complying with Wearable Health Device Regulation
• Which devices does the TGA regulate?
• How are devices approved?
• How does the TGA regulate devices once they are on the market?
Presentation: Conformity assessment evidenceTGA Australia
An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.
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
Presentation: Recall of Therapeutic GoodsTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
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: 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.
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.
The Kenya Pharmaceutical Regulatory Compliance Conference – July 25 – 26, 2017 at the Radisson Blu Hotel, Nairobi.
Compliance in the pharmaceutical industry is a critical issue, particularly in Kenya. Pharmaceutical companies across the globe face unparalleled challenges in the dynamically changing clinical, regulatory and business landscape. As regulatory scrutiny of the Pharmaceutical industry continues to intensify, compliance teams face increasingly complex challenges related to Legal Frameworks and Compliance, Effective Third Party Compliance Strategies, Best Practice Compliance Strategies, Internal Controls and Risk Management, Complexities of HCP interactions.
The inaugural edition of the Kenya Pharmaceutical Regulatory Compliance Conference will provide a venue for industry experts, policymakers, manufacturers, distributors, retailers and inventors to discuss and debate the challenges they face as well as explore new strategies.
Compliance in the pharmaceutical industry is a critical issue, particularly in Kenya. Pharmaceutical companies across the globe face unparalleled challenges in the dynamically changing clinical, regulatory and business landscape. As regulatory scrutiny of the Pharmaceutical industry continues to intensify, compliance teams face increasingly complex challenges related to Legal Frameworks and Compliance, Effective Third Party Compliance Strategies, Best Practice Compliance Strategies, Internal Controls and Risk Management, Complexities of HCP interactions.
The inaugural edition of the Kenya Pharmaceutical Regulatory Compliance Conference will provide a venue for industry experts, policymakers, manufacturers, distributors, retailers and inventors to discuss and debate the challenges they face as well as explore new strategies.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
Australia Patient Support Programs (PSP) Market Report 2022 to 2030Insights10
This report presents a strategic analysis of the Australia Patient Support Programs (PSP) Market and a forecast for its development in the medium and long term. It provides a broad overview of the market dynamics, trends and insights, growth drivers and restraints, segmentation, competitive landscape, healthcare policies, and regulatory framework, reimbursement scenario, challenges, and future outlook. This is one of the most comprehensive reports about the Australia Patient Support Programs (PSP) Market, offering unmatched value, accuracy, and expert insights.
Pharma Policy 2017 - Read it in MedicinMan September 2017 IssueAnup Soans
1. Draft Pharma Policy: The Good, The Bad and The Ugly...............................................1
Interview with Sunil Attavar
2. Career Brand Plan: A Career Stepping
Stone..........................................................9
Soham Wagh
3. Succeeding as Country GM at GSK: A Whitepaper..............................................12
Sundar Ramachandran
4. Role of Digital in the Customer Journey ....................................................................21
Salil Kallianpur
5. Executive Function Disorder .................24
Vivek Hattangadi
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
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.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Presentation: Advertising therapeutic goods to consumers TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
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.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- 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
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
1. SME Assist
Help to navigate the regulatory maze
Avi Rebera
Assistant secretary
Regulatory Engagement and Planning Branch
ARCS conference, Sydney
8 August 2019
2. Disclaimer
This material is provided to you solely for the purpose of providing a record of
what TGA representatives spoke about today.
The papers are not legislative in nature and should not be taken to be
statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part)
advises that:
a) the papers should not be relied upon in any way as representing a
comprehensive description of regulatory requirements, and
b) cannot guarantee, and assumes no legal liability or responsibility for, the
accuracy, currency or completeness of the information contained in this
paper.
1
3. Today’s objectives
To provide:
• information on TGA’s SME Assist and what the service offers
• details on upcoming SME Assist events
• information on where to find more help
2
4. Background
• The 2016 review of Medicines and Medical Devices Regulation
(MMDR) highlighted that small to medium enterprises (SMEs) can
find navigating the ‘regulatory maze’ a challenge
• We need to:
– make the regulation process easier to understand
– provide better support services for SMEs
• Consultations were held in 2016 with:
– Industry organisations
– Government departments
3
5. SME Assist
• Launched 9 June 2017 by the Hon Greg Hunt MP, Minister for
Health
• Targets the needs of:
– SMEs
– start-ups
– researchers
– those unfamiliar with therapeutic goods regulation
• Informs therapeutic R&D groups
• Assists users to understand their regulatory and legislative
obligations
4
6. Since launch, there has been:
116,000 visitors to the SME Assist web page
424 subscribers to SME Assist emails
32,500 uses of interactive decision tools
241 email enquiries answered
11 ‘Meeting Your Obligations’ workshops held across Australia
643 attendees at workshops
2 educational webinars
We have also worked in partnership with:
• universities (Flinders, Macquarie, QUT), industry organisations
(AusBiotech), research organisations (CSIRO, TRI) and the QLD
Government
5
8. Guidance articles
• Various introductory topics:
– basics of regulation
– market authorisation
– when to engage with TGA
– medical devices overview
– useful resources (signposting to other services)
• Case studies (e.g. herbalist, importer and researcher)
• Information is written in plain English and targeted at beginners
7
9. Interactive decision tools
• Designed to help SMEs and researchers:
– better navigate regulatory processes
– understand the regulation of specific products
• Current interactive tools include:
– Is my product a therapeutic good?
– What classification is my device?
– Which clinical trial scheme should I choose?
– What type of GMP application do I require?
(manufacturing medicines)
– What do I require to have a listed medicine in the ARTG?
8
10. Phone and email support
• Provides tailored and efficient assistance to SMEs and researchers
• Enquiries answered directly or forwarded to relevant area
Subscription service
• Keeps subscribers informed about what’s coming up and what’s new
to SME Assist, including:
– upcoming workshops, webinars and events
– new online resources and tools
– news and information relevant to SMEs
9
11. Upcoming events
• Continued rollout of ‘Meeting Your Obligations’ workshops:
– Perth (October 2019)
– Melbourne and Adelaide (November 2019)
– Sydney, Brisbane and Melbourne (2020 - dates to be confirmed)
• Addition of new guidance articles and decision tools:
– Overview of ingredients
– Researcher considerations
• Development of further webinars on specific topics
• Increased social media presence
Subscribe to SME Assist (www.tga.gov.au/sme-assist-email-list) to be
notified about dates for upcoming workshops and information about other
TGA events
10
12. Other stakeholder events
SME Assist will be providing information sessions at:
• Bio Connections Australia Conference, Melbourne August 2019
• ATSA Independent Living Expo, Canberra August 2019
• Bridge Program Symposium, Melbourne October 2019
• GMP Forum, Melbourne November 2019
11
14. Separate and distinct products have their own
ARTG entry
• Every ARTG entry is unique (separate and distinct).
• This ‘uniqueness’ is defined in a certain way depending on what type of therapeutic good you have.
• These definitions can be found in the legislation:
Product type Where to look Section
Medicines Therapeutic Goods Act 1989 16
Biologicals Therapeutic Goods Regulations 1990 11A
Medical devices Therapeutic Goods Act 1989 41BE
13
16. Australian Regulatory Guidelines
• All types of therapeutic goods have their own Australian Regulatory Guidelines to assist applicants and
sponsors with the process of applying for market authorisation.
• Note that these are guidance documents only.
ARGCM for complementary medicines
ARGOM for over-the-counter medicines
ARGPM for prescription medicines
ARGS for sunscreens
ARGMD for medical devices (currently under review)
ARGB for biologicals
ARGATG for advertising therapeutic goods (updated)
15
Disclaimer
Please note that these slides are a summary only and should not be taken as statements of law or policy.
We have established partnerships to deliver workshops and information sessions with:
universities (Flinders University, Macquarie University and The BridgeTech Program, Queensland University of Technology)
industry organisations (AusBiotech)
research organisations (CSIRO, Translational Research Institute) and
state governments (Queensland)
Last but not least, please be aware of the SME Assist pages on our website, which you can access from the front page of the TGA website under the heading ‘Industry’.
Here you’ll find a wealth of information including:
decision tools
useful links, and
upcoming events. END