TGA - SME Assist ‘Navigating therapeutic goods regulation‘

• 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 goods what constitutes an advertisement what responsibilities a sponsor has when advertising product how the world of social media, including hash tags and testimonials ties into advertising some tips and pointers for those working in this space advertising 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:              [email protected] 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.au The advertising hub https://www.tga.gov.au/hubs/advertising-therapeutic-goods The Australian regulatory guidelines for advertising therapeutic goods https://www.tga.gov.au/publication/australian-regulatory-guidelines-advertising-therapeutic-goods-argatg Therapeutic goods advertising code https://www.tga.gov.au/publication/therapeutic-goods-advertising-code Compliance management https://compliance.tga.gov.au/ Advertising enforcement and outcomes https://www.tga.gov.au/advertising-enforcement-and-outcomes Learning resources for advertisers https://www.tga.gov.au/learning-resources-advertisers Can I advertise this therapeutic good to the public? https://www.tga.gov.au/can-i-advertise-therapeutic-good-public Mandatory 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

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• 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 important what Good Manufacturing Practice (GMP) is how this applies to manufacturers of medicines and biologicals the inspection process how 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:              [email protected] 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.au Manufacturing therapeutic goods https://www.tga.gov.au/manufacturing-therapeutic-goods Manufacturing inspections https://www.tga.gov.au/manufacturing-inspections Manufacturing basics https://www.tga.gov.au/manufacturing-basics Good manufacturing practice - an overview https://www.tga.gov.au/good-manufacturing-practice-overview What 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

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• 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 there what and how we test therapeutic goods the current face mask testing program tips 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:              [email protected] 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.au TGA Laboratories https://www.tga.gov.au/tga-laboratories Testing of face masks and respirators https://www.tga.gov.au/testing-face-masks-and-respirators Guidance 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-aspects Testing of therapeutic goods https://www.tga.gov.au/testing-therapeutic-goods Database of TGA laboratory testing results https://www.tga.gov.au/ws-labs-index   Host: Dr Jayne Foster Guests: Dr Lisa Kerr and Lucan Baillie

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• 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-19 how these are regulated where to start if considering supplying these products in Australia how the features of a product can impact how it’s regulated tools and information helpful for those new to supplying therapeutic goods the 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:              [email protected] 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.au The ARTG https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg Disinfectants, sterilants and sanitary products https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-products COVID-19 landing page https://www.tga.gov.au/collection/covid-19 Australian regulatory guidelines for medical devices (ARGMD) https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd Australian regulatory guidelines for OTC medicines (ARGOM) https://www.tga.gov.au/publication/australian-regulatory-guidelines-otc-medicines-argom-0 Is my product a therapeutic good? https://www.tga.gov.au/sme-assist/my-product-therapeutic-good Is my product a medical device? https://www.tga.gov.au/my-product-medical-device What classification is my medical device? https://www.tga.gov.au/sme-assist/what-classification-my-medical-device   Host: Steven Smith-Fleury Guest: Brian Chamberlain

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• 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 TGA what a therapeutic good is the Australian Register of Therapeutic Goods how the COVID-19 pandemic has impacted operations at TGA accessing 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:              [email protected] 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.au The ARTG https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg What is a therapeutic good? https://www.tga.gov.au/what-are-therapeutic-goods Software based medical devices https://www.tga.gov.au/regulation-software-based-medical-devices Risk based approach to regulation https://www.tga.gov.au/tga-regulatory-framework#risk Special Access Scheme (unapproved goods) https://www.tga.gov.au/form/special-access-scheme Authorised Prescribers (unapproved goods) https://www.tga.gov.au/form/authorised-prescribers Medicinal cannabis https://www.tga.gov.au/medicinal-cannabis Advertising hub https://www.tga.gov.au/hubs/advertising-therapeutic-goods Compliance and enforcement hub https://www.tga.gov.au/hubs/compliance-and-enforcement COVID-19 landing page https://www.tga.gov.au/collection/covid-19   Host: Dr Jayne Foster Guest: Gillian Mitchell

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