Original presentation date: July 2021

Overview 

Australia has always been a key player in the commercialisation of Medical Technology. Whether it’s early stage looking to conduct clinical trials, or an established manufacturer looking to distribute into a well-established market, Australia is the perfect place to start.

In this webinar, Brandwood CKC presenters Grant Bennett and TJ Thiel provide a high-level overview as to the paths available into the market including:  

• clinical trial process
• exemption and expedited pathways 
• registration requirements 
• ongoing vigilance 

We’ll have time for an open live Q&A session at the end of the webinar to answer any questions.

Learning objectives

By engagement in this webinar, the delegate will:

• Have an understanding of the overall regulatory requirements 
• Have an overview of the clinical trial processes
• Learn about exemption and expedited pathways
• Understand the registration requirements
• Learn about ongoing vigilance
  
   

Target Audience

This webinar is suitable for all Regulatory Affairs personnel across all sectors of the medical device market.

Speaker

Grant Bennett
Managing Director, Brandwood CKC 

Grant Bennett is an internationally respected leader with more than 20 years’ experience in the commercial, finance and medtech industries. 
 
Joining Brandwood Biomedical in 2013, and a founding member of Brandwood CKC in 2019, Grant is responsible for running all facets of the Australian business and has specialist expertise is in business commercialisation through mergers, acquisitions, and company restructures to optimise business performance at both a financial and operational level. Grant also plays an integral role in the business’ strategic growth and development.
 
Grant has extensive knowledge in regulatory affairs gained through medical devices industry roles across the Asia Pacific. His prior experience includes roles as Regional Regulatory Affairs Manager Asia Pacific and Australia/New Zealand Quality Assurance Manager with a US-headquartered, multinational supplier of professional Medical Devices.
 

Terrance (T.J.) Thiel,
Principal Consultant/Consulting Operations Manager, Brandwood CKC 

TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices.

TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA. He has provided due diligence activities for company acquisitions regarding the target’s business viability, quality system status and regulatory position. TJ’s expertise also supports businesses to create, revise and execute quality systems that are efficient and understood by all employees to provide compliance in a consistent and concise manner.

CPD

This course offers 1 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.

Price 

Members: £70+VAT

Non-members: £95+VAT

Access

Once you have paid for the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase.  
Please note, if you select the pay later option, you will not have access until payment has been cleared. 

Terms and conditions

By purchasing this webinar, you are agreeing to the terms and conditions.