Medical Device Regulatory Workshops | 29 July-2 August 2024

9:00am Monday, 29 July 2024
5:00pm Friday, 2 August 2024
MedTech Workshop
Cliftons Margaret Street
Level 13, 60 Margaret Street
Sydney, New South Wales 2000
Australia

The Medical Device Regulatory Workshops 2024 will be held in Sydney from Monday 29 July to Friday 2 August 2024.

At the request of our members, we are excited to announce a full week of Regulatory Workshops with TGA.  There are 7 workshops in total, taking a deep dive into these areas of focus:

 
Pre-Market (full-day)

Monday 29 July: 9am-5pm

Learning outcomes 

1. Basics of Australian Medical Device Regulations and TGA structure and personnel 

2. Leveraging comparable overseas regulator approvals for TGA applications 

3. TGA applications, variation applications, and application audits – best practice guidelines for a good submission 

4. TGA CA applications - best practice guidelines for a good submission 

5. Case studies 

6. Q&A with TGA 

 
Post-Market (full-day)

Tuesday 30 July: 9am-5pm

Learning outcomes 

1. Adverse events - definitions, sponsor and manufacturer responsibilities, TGA report review process  

2. Recalls - flow, types, decision-making about outcomes   

3. Reviews, safety, reclassification, managing feedback on reforms 

4. Q&A with TGA 

 
SaMD (full-day)

Wednesday 31 July: 9am-5pm

Learning outcomes 

1. Overview of SaMD regulation 

2. Classification rules 

3. Software carve-out 

4. Clinical Decision Support System (CDSS) 

5. Evidence, artifacts, AI, cybersecurity 

6. Q&A with TGA 

 
Clinical Evidence (half-day)

Thursday 1 August: 9am-12.30pm

Learning outcomes 

1. Pre-clinical requirements 

2. Post-clinical requirements 

3. Q&A with TGA 

 
Quality Management System (half-day)

Thursday 1 August: 1.30pm-5pm

Learning outcomes 

1. ISO 1345 

2. MDSAP 

3. Q&A with TGA 

 
Biocompatibility / Sterility (microbiological) / Engineering (half-day)

Friday 2 August: 9am-12.30pm

Learning outcomes 

1. TBC – As a new session this is still being formulated by TGA 

2. Opportunity for Q&A with TGA 

 
Advertising (half-day)

Friday 2 August: 1.30pm-5pm

Learning outcomes 

1.      Overview of advertising legislation

2.      Complying with the Advertising Code

3.      Applying for approval to use restricted representations

4.      Q&A with TGA

 

Registrations are open now. 


 

Details:

  • Date/Time: Monday 29 July to Friday 2 August 9:00 to 17:00 AEST
  • Location: Cliftons, Level 13, 60 Margaret Street, Sydney
  • Inclusion: Morning tea, lunch and afternoon tea (during your scheduled workshop)

Note: These are face-to-face workshops, there are no recordings available. Placements are strictly limited.


Registration

The series contains a choice of 7 workshops, priced for members and non-members. You can select as many as you wish. There are discounts available for those attending the entire week.

Full day workshops (available Mon 29 July, Tues 30 July, Wed 31 July):

  • Members $990pp incl GST per workshop
  • Non-Members $1,287pp incl GST per workshop

Half day workshops (available on Thursday 1 August and Friday 2 August):

  • Members $495pp incl GST per half day workshop
  • Non-Members $645pp incl GST per half day workshop

Attend the entire week (all 7 workshops):

  • Members $4,250pp incl GST (normally $4,950, you will save $700)
  • Non-Members $5,635pp incl GST (normally $6,435, you will save $800)

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