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.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
An exploration of the topic of Data Integrity including consequences of international regulatory collaboration on the subject, highlights of recent overseas and international guidance documents, as well as common misconceptions.
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.
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
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
An exploration of the topic of Data Integrity including consequences of international regulatory collaboration on the subject, highlights of recent overseas and international guidance documents, as well as common misconceptions.
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.
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
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
Presentation: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
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
Presentation: What's trending in medicines regulation? A January 2017 reflectionTGA Australia
This presentation provides a local perspective on recent developments in the medical technology and pharmaceutical landscape, and the future of the TGA in a global context.
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
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
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'.
Expert review of medicines and medical devices regulation: Prescription medic...TGA Australia
This presentation outlines proposals for implementation of several recommendations from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports.
TGA presentation: Codeine Industry Forum - Regulatory options for up-schedulingTGA Australia
To provide sponsors of OTC codeine products with information on how to submit an application to change the class of their product from OTC to prescription medicine
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
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: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
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
Presentation: What's trending in medicines regulation? A January 2017 reflectionTGA Australia
This presentation provides a local perspective on recent developments in the medical technology and pharmaceutical landscape, and the future of the TGA in a global context.
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
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
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'.
Expert review of medicines and medical devices regulation: Prescription medic...TGA Australia
This presentation outlines proposals for implementation of several recommendations from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports.
TGA presentation: Codeine Industry Forum - Regulatory options for up-schedulingTGA Australia
To provide sponsors of OTC codeine products with information on how to submit an application to change the class of their product from OTC to prescription medicine
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
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.
International regulatory cooperation: more important than everTGA Australia
The presentation was given by the TGA at the 2014 ARCS Scientific Congress, and covers the importance and future of international regulatory cooperation
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: 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.
A Rare International Dialogue (Saturday May 11, 2019)
Drivers of Drug Development – Regulatory Collaboration
European regulatory approaches to drugs for rare diseases - Daniel O’Connor, European Medicines Agency/Medicines and Healthcare products Regulatory Agency, UK
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
Regulatory Update Panel
An overview of all Health Canada policies supporting access to Drugs for Rare Diseases, including regulatory pathways and support for innovation, patient engagement, Special Access Programs, aligned HC/CADTH/INESSS, international harmonization, post-market monitoring, support for patient registries, current status and relevance of biosimilars for rare disease patients
Rare Disease Day Conference 2020 March 9-10
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.
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
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
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: 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.
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.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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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
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.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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.
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
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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!
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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.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
The world of Regulatory convergence: an Australian reflection
1. The world of Regulatory convergence: an
Australian reflection
John Skerritt
National Manager, TGA / Deputy Secretary, Department of Health
ARCS conference, May 2015
2. • I’ve spoken at the 2013 and 2014 ARCS meetings on convergence but now it’s really
gaining momentum!
• PM’s announcement in October 2014
• Future directions of international regulatory convergence activities will depend on the
Government’s response to recommendations of the Expert Review of Medicine and
Medical Device Regulation
• Several issues were raised in the review discussion paper on regulatory convergence,
and use of other evaluations
• Work underway – medicines and devices
• New collaborations and some concrete results
1
3. Expert Review of Medicine and Medical Device Regulation
• First report (prescription and OTC medicines, devices) was reported to Government
on March 31 2015 and the next steps are under now consideration by Government
• Second report (complementary medicines and advertising) will be submitted to
Government by June 30 2015
• Collaboration with international regulators featured heavily in the Review Panel’s
discussion paper of November 2014
• Strong focus on international cooperation follows PM’s statement in October 2014
2
4. PM’s Media release
14 October 2014
“ if a system, service or product has been approved under a trusted international
standard or risk assessment, then our regulators should not impose any additional
requirements for approval in Australia, unless it can be demonstrated that there is a
good reason to do so…….
As an important first step, the Government will enable Australian manufacturers of
medical devices the option of using EU certification in place of TGA certification.”
3
5. Some questions raised on international convergence in
the Nov 2014 discussion paper
• Should Australia recognise other international regulators as ‘trusted’ for medicines
and device approvals ?
– how to determining whether an overseas regulator is “trusted” ?
– how would their evaluations or decisions be used in practice ?
• Should accelerated or provisional approvals be implemented ?
– would this alter how decisions by other regulators should be used ?
• Are there aspects of safety, quality or efficacy that need to be considered in the
Australian context ?
• Should we maintain Australian specific requirements with respect to labelling and post
market monitoring?
4
7. How greater international medicines collaboration could work
in practice?
Issues in the discussion paper and review submissions
• Predicated on the Australian applicant providing full data package and full, unredacted copies
of evaluation reports to TGA
• What Australia-specific work would be done – e.g. Aust medicine use patterns, RMPs,
pregnancy classification, labelling, AusPARS ?
• More straightforward if overseas submission is for same product and clinical context - what
about similar but not identical products?
• Sponsors should not be compelled to use an overseas evaluation - in a number of cases this
would delay registration
• Retention of sovereign decision making by Australia
• Recognition that Australia needs to contribute evaluation reports and participate in worksharing
initiatives too 6
8. Current major medicines collaborations
• ICH (International Conference on Harmonisation…)
• PIC/S (Pharmaceutical Inspection Coop’n Scheme)
• International Generic Drug Regulators Pilot
• ACSS (Australia, Singapore, Switzerland, Canada) and Australia - Canada Regulatory
Cooperation:
‒ Manufacturing compliance and enforcement
‒ Generic medicines
‒ Good review practices
‒ Risk benefit assessment / communication methodology
‒ Secure portal for information exchange
‒ OTC medicines (Australia-Canada)
7
9. International Coalition of Medicines Regulatory Agencies –
formed Dec 2013
• First regulatory coalition at agency head level
– 23 countries plus EMA, EU and WHO
• Leverage/strategic oversight of existing initiatives
• Initial priorities:
– Better information sharing mechanisms between regulators (e.g. IT systems, commercial-in-
confidence)
– United industry engagement
– GMP Inspection worksharing
– Generic medicines convergence and worksharing
– Capacity building of emerging regulators
8
10. Generic medicines collaboration
• Access to generics very important in managing health care
costs
• But there are increasing numbers of submissions and
complexity of products
• So need to increase the efficiency of regulatory review
– More consistent dossier/ product requirements across
countries
– Collaboration between regulators on aligned submissions
could provide faster evaluation times and reduced fees
– Potential for move away from requirement for local reference
products
9
11. Response: a new, integrated approach
International Generic Drug Regulator’s Programme (IGDRP)
• Senior scientific staff of 13 regulators
• Convergence of specific technical requirements e.g. bioequivalence, biowaivers, choice of foreign
reference products
• Assessment of drug master files and report structures so that the evaluations of other regulators
can be used in worksharing
International Coalition of Medicines Regulatory Authorities
• Generics project focuses on strategic issues to establish a framework for routinely exchange
evaluation reports:
‒ Regulator business processes/ confidential information
‒ Legal frameworks
‒ Secure platforms for sharing confidential information
‒ Analysis to identify additional opportunities for worksharing
10
12. Pilots being implemented by TGA
• Information exchange on medicines which either have recently received market
authorisation (share reports) OR under consideration and suitable for worksharing
• EU Centralised and Decentralised Procedure on evaluation of generic drug
applications
– an application submitted under EU DCP will be submitted at the same time to TGA
– offers applicants the potential to seek market authorisation in a number of markets at the same
time
– Australian registration decision is made by TGA
• ACSS and TGA-Canada Collaboration
– Collaborated on over a dozen applications in 2014/15
– Collaboration on complementary medicines ingredients
11
14. Some specific devices questions raised in the Review
discussion paper
• Should the TGA undertake its own assessment of the competence of European Notified
Bodies?
– i.e. “go it alone” vs “piggybacking” on EU assessments
• How could concerns about the quality of some overseas conformity assessments be
managed?
• Should Australia be able to recognise decisions by FDA and “trusted” non-European
systems?
• Should Australia adopt the EU classification system for devices?
13
15. The European System: a quick recap
• European Union ‘directives’ = Therapeutic Goods legislation and regulations
• Independent commercial entities (Notified Bodies) are designated (authorised) by the
government regulator in each EU country to apply conformity assessment procedures
(examine safety and efficacy information, assess clinical data)
• Conformity assessment certification leads to a “CE mark”, which provides authority to
market within Europe, but TGA undertakes application audits of higher risk devices
• New, more stringent EU regulations may be adopted as soon as 2016 – but 31 countries
are involved in negotiations!
14
16. How does this impact Australia?
TGA accepts CA certification from Notified Bodies to support applications for ARTG inclusion,
but highest risk devices have application audits
ARTG =
48,000
entries
Highest risk
devices (Class III
and AIMD) =
4,300
Manufactured
overseas= 4,250
(>98%)
15
17. What is confidence building?
• Recent events (e.g. PIP implants, metal-on-metal hips, gynae meshes) highlighted need
for closer scrutiny of Notified Body processes and outputs
• Australia needs to be confident that Notified Bodies have appropriate:
‒ operating procedures
‒ quality management systems
‒ data management processes
‒ evaluators with appropriate technical qualifications
• The issue is how do we go about confidence building?
16
18. Australia’s approach (pending report of Review of
Medicines and Medical Devices regulation)
• Participation by TGA staff as observers in EU joint assessments of targeted Notified
Bodies is already underway
• Continue development of clinical evidence assessment guidelines
• Enhanced effort to build confidence in clinical assessments of targeted Notified Bodies
• Policy meetings in Europe with major designating authorities (UK, Germany,
Netherlands), notified bodies, Team NB (industry representative body) and European
Commission held by TGA in November 2014
• MDSAP also contributes to confidence building (see later)
17
19. International Medical Device Regulators Forum (IMDRF)
• IMDRF was established in 2011 to build on Global Harmonisation Taskforce (GHTF)
guidance
• Adoption of GHTF guidance a facilitates mutual recognition of most areas of device
regulation across the product life-cycle
• Members:
Australia, Brazil, Canada, China, EU, Japan, Russia, USA
• Observers and Affiliates:
WHO, APEC’s Life Sciences Innovation Forum, Regulatory Harmonization Steering
Committee, Asian Harmonization Working Party, Pan American Health Organization
18
20. IMDRF work program
• Medical Device Single Audit Program
• Review system for confidential exchange of information on
serious adverse events
• Implementation of Unique Device Identification system
• Review of recognised standards for devices to increase
consistency
• Regulated Product Submission
• Software as a Medical Device
• Integrating Patient Registries and tools for enhanced device
evaluation and tracking
19
21. MDSAP
• Medical Devices Single Audit Program will allow a single regulatory audit of a medical
devices manufacturer to satisfy needs of multiple regulators (Australia, Brazil,
Canada, USA)
• Developing a standard set of requirements for auditing organizations performing
regulatory audits of medical device manufacturers’ quality management systems
• Several Notified Bodies and manufacturers have agreed to participate and several audits
already carried out
• Now encouraging more manufacturers to participate
20
22. GMP inspection collaboration
• Involvement in PIC/S
• Widespread use of GMP clearances already significantly reduces the number of
overseas inspections required
• Joint inspections with other regulators
• But better sharing of confidential information such as inspection plans and reports is
needed
21
23. Post market vigilance – the forgotten cousin of
international collaboration
• Needs to be strengthened if more product approvals made on less complete evidence,
and/or if provisional approval is adopted
• Long-established and prompt communication between regulators on incidents and
decisions but some groups now developing to discuss potential regulatory actions
• Strong media interest when regulators reach different conclusions on the need for
product withdrawal, rescheduling or change to the PI - informal communication is critical
• Opportunities for greater international collaboration - e.g. mining bigger
pharmacovigilance data sets and registry data
• New WHO ADR database (www.vigiaccess.org) valuable but does not have data on
numbers of people exposed to each drug and frequency of reporting varies by country
22
24. Different regulators may still reach different conclusions
using similar data… including on market authorisation or
particular indications
23
25. To conclude
• Increasing global cooperation between regulators is now happening, and industry is
starting to see the benefits
• The future direction of international collaboration activities and of medicine and
device regulation overall will depend on the Government’s response to recommendations
of the Expert Review
• Work is nonetheless continuing on several fronts – generic and complementary
medicines, OTC monographs, device confidence building and inspections, GMP systems
and inspections
• But establishing systems for global collaboration on New Chemical Entity evaluation
is the biggest “prize”
• Being able to share experiences with other international regulators on “what works”
is also very important 24