TGA - SME Assist ‘Navigating therapeutic goods regulation‘
What is the TGA and what do they do?

What is the TGA and what do they do?

July 12, 2021

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:              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

 

Host: Dr Jayne Foster

Guest: Gillian Mitchell

Supplying certain therapeutic goods for COVID-19

Supplying certain therapeutic goods for COVID-19

July 12, 2021

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:              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

 

Host: Steven Smith-Fleury

Guest: Brian Chamberlain

Role of the TGA Laboratories

Role of the TGA Laboratories

July 13, 2021

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:              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

 

Host: Dr Jayne Foster

Guests: Dr Lisa Kerr and Lucan Baillie

Australian  manufacturing licences and GMP for medicines and biologicals

Australian manufacturing licences and GMP for medicines and biologicals

July 14, 2021

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:              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

 

Host: Steven Smith-Fleury

Guest: Nadia Saleh

Advertising therapeutic goods in Australia

Advertising therapeutic goods in Australia

July 14, 2021

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:              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

 

Host: Dr Jayne Foster

Guest: Leanne McCauley

Podbean App

Play this podcast on Podbean App