EOI - Introduction to Regulation of In Vitro Diagnostic Medical Devices (IVDs)

 

Workshop overview

Once medical devices or in vitro medical devices (IVDs) are entered onto the Australian Register of Therapeutic Goods (ARTG), the sponsor and manufacturer are responsible for ensuring the continued performance and safety of their devices. The TGA imposes post-market obligations that need to be followed. These include ongoing conformity to the essential principles, device incident reporting, complaint, adverse event reporting and maintenance of the technical file. The TGA continues to move towards a post-market risk-based approach for the regulation of therapeutic goods so it is important that the sponsor and manufacturer report incidents and adverse eventse as they occur, capture trends in incidents and complaints through their Quality Management System (QMS) and are ready for post-market audits conducted by TGA.

This intermediate one (1) day course covers an overview of post-market obligations of the sponsor and manufacturer. It will be delivered as a virtual workshop, however, where possible will be interactive and use real-world examples to illustrate and compliment the course material. You shall find it informative, challenging, and entertaining.

Outline

The workshop is structured in two (2) sections over 1 day:

  1. Understanding the post-market vigilance responsibilities of the sponsor and manufacturer
  2. Maintenance of the technical file according to the STED and IMDRF formats in compliance to the essential principles and in readiness for a TGA post-market audit

The workshop is structured in two (2) sections over 1 day:

  1. Understanding the post-market vigilance responsibilities of the sponsor and manufacturer
  2. Maintenance of the technical file according to the STED and IMDRF formats in compliance to the essential principles and in readiness for a TGA post-market audit

Learning objectives

By the end of this workshop, attendees should be able to:

  1. Explain the regulations that impose post-market obligations
  2. Differentiate the regulatory responsibilities of the sponsor and manufacturer in the post-market phase of a medical device
  3. Define incidents, complaints, adverse events and recalls
  4. Apply AE reporting guidelines and timelines to real examples
  5. Explain device incident reporting, including the role of the QMS and required follow up
  6. Compile and maintain a technical file according to the Summary Technical Documentation (STED) and International Medical Device Regulators Forum (IMDRF) formats
  7. Summarise the types of documents in the STED
  8. Respond to a post-market TGA audit

 

Speaker Bio

Paul has more than 25 years’ experience in the diagnostics, biotechnology, medical device, and bio-pharmaceutical industry. His expertise spans clinical research, regulatory affairs, pharmacovigilance, training, quality management and process re-engineering for large pharmaceutical companies, biotech and medical device/IVD start-up ventures. Paul is responsible for consolidating and growing the educational offering for medical device regulatory professionals.

 

Who should attend

  1. Regulatory professionals working in industry who need a refresher course including current updates on IVDs
  2. Anyone aspiring to take on the role of a regulatory professional with a manufacturer of IVDs
  3. Industry professionals working in cross functional roles needing to better understand post-market obligations of the sponsor and manufacturer
  4. University/PhD graduates working in a university spin off company, in an IVD or medical device start-up environment and medical device/diagnostic company technical/sales representatives

Continuing Professional Development (CPD) points

Upon completion of this workshop, attendees will receive 7 CPD points

Entry criteria

There are no specific entry criteria for this workshop. If you have any questions on your suitability for this workshop, please call the ARCS Office (02) 8905 0829.

Registration fees

Workshop fees (incl. GST):
Early bird - until 4 April 2023
ARCS Member - $540
Retired/Student Member - $405
Non Member - $885

Standard – from 5 April 2023
ARCS Member - $710
Retired/Student Member - $540
Non Member - $1140

Registration terms and conditions

Please note that virtual workshops at ARCS cover the same content as the physical (face-to-face) workshop. The training material, exercises and student workbook have been redesigned to ensure that the same learning outcomes are achieved as traditional workshops.

The registration fees for virtual workshops have been reduced by $150 per person, per workshop day to reflect the reduction in venue and catering costs associated with a face-to-face workshop.

Virtual classroom

This workshop runs for one full day from 09:00-17:00

Attendee requirements:

  1. Computer/laptop connected to power
  2. Good internet access (1Mbps or better – broadband recommended)
  3. A charged mobile phone and headphones (if using your phone for audio)
  4. Phone charger – given the event goes all day, you will need a way of charging your phone
  5. Headphones for computer audio (if using computer audio)
  6. A quiet room/space

 

If you're interested in taking this course, please provide your information below, and we'll inform you about the upcoming session's schedule.