TGA - SME Assist ‘Navigating therapeutic goods regulation‘

SME Assist

Helping small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia. read less
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Episodes

Advertising therapeutic goods in Australia
Jul 14 2021
Advertising therapeutic goods in Australia
In this episode, we be speak with Leanne McCauley, Director of the Advertising and Compliance, Education and Policy Section at TGA about: what you can and can’t do when advertising therapeutic goodswhat constitutes an advertisementwhat responsibilities a sponsor has when advertising producthow the world of social media, including hash tags and testimonials ties into advertisingsome tips and pointers for those working in this spaceadvertising compliance, including what constitutes a breach, potential penalties and how to make a report This podcast series is presented by the SME Assist team at the TGA. SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly. Phone:            1800 020 653 Email:              sme.assist@tga.gov.au Social Media: https://www.tga.gov.au/social-media TGA BLOG:      https://www.tga.gov.au/blogs/tga-topics   Links and useful information TGA website tga.gov.auThe advertising hub https://www.tga.gov.au/hubs/advertising-therapeutic-goodsThe Australian regulatory guidelines for advertising therapeutic goods https://www.tga.gov.au/publication/australian-regulatory-guidelines-advertising-therapeutic-goods-argatgTherapeutic goods advertising code https://www.tga.gov.au/publication/therapeutic-goods-advertising-codeCompliance management https://compliance.tga.gov.au/Advertising enforcement and outcomes https://www.tga.gov.au/advertising-enforcement-and-outcomesLearning resources for advertisers https://www.tga.gov.au/learning-resources-advertisersCan I advertise this therapeutic good to the public? https://www.tga.gov.au/can-i-advertise-therapeutic-good-publicMandatory information required in advertising for therapeutic goods https://www.tga.gov.au/mandatory-information-required-advertising-therapeutic-goods   Host: Dr Jayne Foster Guest: Leanne McCauley
Australian  manufacturing licences and GMP for medicines and biologicals
Jul 14 2021
Australian manufacturing licences and GMP for medicines and biologicals
Join us for this episode as we speak with Nadia Saleh, Inspector in the Manufacturing Quality Branch at TGA and discuss: what role TGA plays in ensuring quality manufacturing practices and why this is importantwhat Good Manufacturing Practice (GMP) ishow this applies to manufacturers of medicines and biologicalsthe inspection processhow COVID-19 has affected the way we work We also learn about some of the innovative ways TGA is working with manufacturers of medicines and biologicals including some of the technology being used for remote inspections. This podcast series is presented by the SME Assist team at TGA.  SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly. Phone:            1800 020 653 Email:              sme.assist@tga.gov.au Social Media: https://www.tga.gov.au/social-media TGA BLOG:      https://www.tga.gov.au/blogs/tga-topics   Links and useful information TGA website tga.gov.auManufacturing therapeutic goods https://www.tga.gov.au/manufacturing-therapeutic-goodsManufacturing inspections https://www.tga.gov.au/manufacturing-inspectionsManufacturing basics https://www.tga.gov.au/manufacturing-basicsGood manufacturing practice - an overview https://www.tga.gov.au/good-manufacturing-practice-overviewWhat type of GMP application do I require? https://www.tga.gov.au/good-manufacturing-practice-application-decision-tree   Host: Steven Smith-Fleury Guest: Nadia Saleh
Role of the TGA Laboratories
Jul 13 2021
Role of the TGA Laboratories
In this episode, we take a peek behind the curtains of the TGA laboratories with Dr Lisa Kerr, Assistant Secretary of the Laboratories Branch at TGA and Lucan Baillie, Director of the Biomaterials and Engineering section in the Laboratories Branch at TGA to discuss: the history of the TGA labs and what actually happens therewhat and how we test therapeutic goodsthe current face mask testing programtips for sponsors providing samples to TGA for testing This podcast series is presented by the SME Assist team at TGA. SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly. Phone:            1800 020 653 Email:              sme.assist@tga.gov.au Social Media: https://www.tga.gov.au/social-media TGA BLOG:      https://www.tga.gov.au/blogs/tga-topics   Links and useful information TGA website tga.gov.auTGA Laboratories https://www.tga.gov.au/tga-laboratoriesTesting of face masks and respirators https://www.tga.gov.au/testing-face-masks-and-respiratorsGuidance on medical/surgical face masks and respirator standards - key performance aspects https://www.tga.gov.au/publication/guidance-medicalsurgical-face-masks-and-respirator-standards-key-performance-aspectsTesting of therapeutic goods https://www.tga.gov.au/testing-therapeutic-goodsDatabase of TGA laboratory testing results https://www.tga.gov.au/ws-labs-index   Host: Dr Jayne Foster Guests: Dr Lisa Kerr and Lucan Baillie
Supplying certain therapeutic goods for COVID-19
Jul 12 2021
Supplying certain therapeutic goods for COVID-19
In this episode, we talk with Brian Chamberlain from the Medical Devices Authorisation Branch at TGA and explore: some of the products being supplied for COVID-19how these are regulatedwhere to start if considering supplying these products in Australiahow the features of a product can impact how it’s regulatedtools and information helpful for those new to supplying therapeutic goodsthe application process This podcast series is presented by the SME Assist team at TGA. SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly. Phone:            1800 020 653 Email:              sme.assist@tga.gov.au Social Media: https://www.tga.gov.au/social-media TGA BLOG:      https://www.tga.gov.au/blogs/tga-topics   Links and useful information TGA website tga.gov.auThe ARTG https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artgDisinfectants, sterilants and sanitary products https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-productsCOVID-19 landing page https://www.tga.gov.au/collection/covid-19Australian regulatory guidelines for medical devices (ARGMD) https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmdAustralian regulatory guidelines for OTC medicines (ARGOM) https://www.tga.gov.au/publication/australian-regulatory-guidelines-otc-medicines-argom-0Is my product a therapeutic good? https://www.tga.gov.au/sme-assist/my-product-therapeutic-goodIs my product a medical device? https://www.tga.gov.au/my-product-medical-deviceWhat classification is my medical device? https://www.tga.gov.au/sme-assist/what-classification-my-medical-device   Host: Steven Smith-Fleury Guest: Brian Chamberlain
What is the TGA and what do they do?
Jul 12 2021
What is the TGA and what do they do?
We speak with Gillian Mitchell, First Assistant Secretary of the Regulatory Practice and Support Division at TGA and learn about: the role of TGAwhat a therapeutic good isthe Australian Register of Therapeutic Goodshow the COVID-19 pandemic has impacted operations at TGAaccessing unapproved therapeutic goods like medicinal cannabis This podcast series is presented by the SME Assist team at TGA.  SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly. Phone:            1800 020 653 Email:              sme.assist@tga.gov.au Social Media: https://www.tga.gov.au/social-media TGA BLOG:      https://www.tga.gov.au/blogs/tga-topics   Links and useful information TGA website tga.gov.auThe ARTG https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artgWhat is a therapeutic good? https://www.tga.gov.au/what-are-therapeutic-goodsSoftware based medical devices https://www.tga.gov.au/regulation-software-based-medical-devicesRisk based approach to regulation https://www.tga.gov.au/tga-regulatory-framework#riskSpecial Access Scheme (unapproved goods) https://www.tga.gov.au/form/special-access-schemeAuthorised Prescribers (unapproved goods) https://www.tga.gov.au/form/authorised-prescribersMedicinal cannabis https://www.tga.gov.au/medicinal-cannabisAdvertising hub https://www.tga.gov.au/hubs/advertising-therapeutic-goodsCompliance and enforcement hub https://www.tga.gov.au/hubs/compliance-and-enforcementCOVID-19 landing page https://www.tga.gov.au/collection/covid-19   Host: Dr Jayne Foster Guest: Gillian Mitchell