GCP for Medical Devices
*New to 2022!
This 4 hour workshop introduces you to medical devices and the internationally recognised and endorsed Good Clinical Practice standard for medical devices (ISO 14155: 2020). It will help you to understand the importance of ethically sound research design and conduct and how applying GCP principles promotes excellence in science, data quality, and supports the safety and wellbeing of research participants.
Participants can claim 3 CPD points on completion of the course.
On successful completion of this module, you should be able to:
About the Facilitator
Dr Mark Flynn
Dr Mark Flynn is a highly experienced MedTech clinical leader and strategist, particularly in identifying and solving the wicked challenges in healthcare. He has been responsible for the launch of over 20 medical devices for many millions of people globally. He is a clinical strategist who is adept at R&D and new product introduction into global markets. During his career he has worked and lived in Australia, Europe, USA, China, and Latin America.
Mark has held senior executive leadership positions at Cochlear Ltd, Demant A/S, and for medtech start-ups in Europe (e.g., Wise Neuro & IQORO) and Australia (e.g., Atmo Biosciences, Hemideina Pty Ltd). Mark was awarded a PhD in Medicine (1998) from the University of Melbourne. In 2017 he was awarded dual MBAs from Georgetown University (USA) and ESADE School of Business and Law (Spain).
Mark has sponsored medical device clinical trials in Europe, USA, Latin America, Asia, and Australia. Often complex multicentre studies for regulatory approval/clearance ad post market follow-up. He has developed his strategy to deliver clinical trials meeting regulatory requirements while mixing in pragmatism to deliver marketing and reimbursement outcomes at the same time.
$550pp plus GST
Discounts apply for group bookings of 10 or more.
2022 Virtual Workshop Dates
PRAXIS Australia has the right to cancel a workshop or training session (or move the event format online) due to unforeseen circumstances such as low registration/attendance numbers or changes in Government restrictions surrounding the ongoing COVID19 pandemic. For more information regarding our Cancellation Policy and your rights as a student, please see our Student Terms and Conditions document.