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$1980 Inc. GST for members, $2574 Inc. GST for non-members
Regulatory Affairs for Medical Devices Workshop - Sydney

Speciality Classification
Medical Doctors
Start Date
25-Aug-2022
Location
Sydney, New South Wales 2000
End Date
26-Aug-2022
Delivery
Face to face
Duration
2 days
MTAA has organised a two-day workshop on Regulatory Affairs for Medical Devices Workshop Sydney from 25-26 August 2022. This interactive workshop will provide detailed coverage of the medical device regulations in Australia.
The workshop will run as two full-day sessions:
- Thursday, 25 August from 9:00 to 17:00 AEST
- Friday, 26 August from 9:00 to 17:00 AEST
Location Cliftons Sydney, 60 Margaret Street, Sydney Australia
Inclusions
- Morning tea on both days
- Lunch on both days
- Afternoon tea on both days
Learning outcomes
- Basics of Australian Medical Device Regulations and TGA structure and personnel
- QMS requirements – ISO 13485, MDSAP
- Intended use and classification of Medical Devices
- Market authorisation - EU & FDA
- Leveraging comparable overseas regulator approvals for TGA applications
- TGA applications, variation applications, and application audits – Best practice guidelines for a good submission
- TGA CA applications - Best practice guidelines for a good submission
- Essential Principles, Risk Management, and Clinical Evidence Requirements
- Case studies
- Most recent regulation changes and impacts
- Q&A with TGA
Who should attend?
-
Regulatory professionals should attend the training.
How much does it cost?
- $1,980 Inc. GST for members
- $2,574 Inc. GST for non-members
Delivery
Title
Regulatory Affairs for Medical Devices Workshop - Sydney
Speciality Classification
Interest Areas / Topics Covered
Technology to assist efficiency of medical professionals
Provider Type
Education Provider
Duration
2 days
Start Date
25-Aug-2022
End Date
26-Aug-2022
Start Time
9:00 am
Price Details
$1980 Inc. GST for members, $2574 Inc. GST for non-members
Location
Sydney, New South Wales 2000
Price:
$1,980.00
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