EOI - Introduction to Regulatory Affairs of Medical Devices


Workshop Overview

The role of the regulatory affairs professional working or aspiring to work in the medical device/medical technology sector is increasingly challenging with the rapidly changing technology and a constant shift in global regulations. This two (2) day entry level course provides a comprehensive overview of the regulation. It is delivered as a virtual workshop with interactive and real-life examples to illustrate and support the course material.

You can expect to gain in confidence as a regulatory professional and the course will provide foundation knowledge to progress your career. You shall find it informative, challenging, and entertaining.

Outline

Speaker Bio

 

Paul Cohen 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. Junior regulatory professionals already in the industry (less than 12 months experience) with a desire for a refresher course including current updates;
  2. Anyone aspiring to take on the role of a regulatory professional
  3. Industry professionals working in cross functional roles needing to better understand the regulatory process
  4. This course is also ideal for university/PhD graduates working in a university spin-off company in a start-up environment.

Continuing Professional Development (CPD) points

Upon completion of this workshop, attendees will receive 14 CPD points

Learning objectives

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

  1. Appreciate the Australian regulatory environment, including the objectives of the Therapeutic Goods Act and the role of the Therapeutic Goods Administration (TGA) in the pre- and post-marketing phases of a medical device’s life cycle
  2. Compare and contrast regulations in Australia to Europe and the United States of America
  3. Explain the different kinds of medical devices and interpret the classification rules
  4. Differentiate the regulatory responsibilities of the sponsor and manufacturer in the pre- and post-market phases
  5. Discuss the essential principles and identify those that apply to different medical devices
  6. Determine conformity assessment pathways, including the roles of a notified body
  7. Compare the use of ISO 13485 versus Medical Device Single Audit Program (MDSAP) as manufacture’s evidence
  8. Lodge a medical device application with the TGA and understand the types of application audits that may be called by the TGA
  9. Describe the requirements for adverse device events reporting
  10. Describe the regulation of contemporary devices such as software and custom (3D printed) products
  11. Apply clinical evidence requirements
  12. Describe the skills and behaviours which make a medical device regulatory professional successful in the wider project team

 

Entry criteria

The workshop is open to everyone with an interest in the regulation of medical devices.

Preferably, participants hold relevant tertiary qualifications in one of the following disciplines: physics, chemistry, electrical/biomedical/mechanical or related engineering.

As the course is delivered in English, proficiency is assumed.

Registration fees

Workshop fees (incl. GST):
Early bird - until 25 August 2023
ARCS Member - $1005
Retired/Student Member - $745
Non Member - $1660

Standard - from 28 August 2023
ARCS Member - $1330
Retired/Student Member - $100
Non Member - $2145

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 two full days from 09:00-17:00 AEDT

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

Testimonials

"Very good course that has provided me with reinforced confidence with medical device registration as well as provide new information/learning for areas I have not yet had an opportunity to work on. The facilitator was well paced with the information and was able to respond to all questions immediately, or investigated a response during breaks. It was great to have a well informed and experienced professional running the course." Regulatory Affairs Manager, Guerbet Australia.

"Thank you, course was fantastic." Student, Monash University.

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