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ISCT Webinar: A New Dawn of Stem Cell Medicine OR Unfettered Patient Exploitation?

Thursday, October 13, 2016  
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A New Dawn of Stem Cell Medicine OR Unfettered Patient Exploitation? Lessons from Unregulated Clinics in Australia and Japan
Organized by the ISCT Australia & New Zealand Legal & Regulatory Affairs Committee

Event Date: 
Tuesday, October 18, 2016 at 18:00 PDT21:00 EDT
Wednesday, October 19, 2016 at 09:00 SGT12:00 AEDT


Registration Deadline: Tuesday, October 18, 2016
Registration for Members: $105; Non-Members: $120

 

Chair: Dominic Wall, PhD, FFSc, (RCPA), Chief Scientific Officer - Cell Therapies Pty Ltd & Chair ISCT ANZ LRA Committee

Speakers: 

  • Megan Munsie, PhD, Head  - Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, Department of Anatomy and Neuroscience, The University of Melbourne, Australia

  • Tamra Lysaght, PhD, Director of Phase III Health Ethics, Law and Professionalism Programme, Centre for Biomedical Ethics, National University of Singapore, Singapore


About the Webinar:

The availability of unproven stem cell treatments is often assumed to be a feature of low-to-middle income economies that lack the resources to control medical claims and entrepreneurs offering questionable treatments to patients with intractable and devastating diseases. However both Japan and Australia are running experiments in deregulation which is creating new business models based upon unproven treatments.

Dr. Megan Munsie from the University of Melbourne will present her perspective on the explosion in stem cell clinic activity based upon Australia’s unique regulatory experiment of having a medical practitioner exemption framework for supply of unproven autologous cell-based treatments that is unrestricted by either homologous use or by the extent of manipulation of the cells.

Dr. Tamra Lysaght from the National University of Singapore will share her perspective on the new legislative framework for regenerative medicine in Japan and the impacts it has had on clinics offering unproven treatments with autologous stem cells.

The speakers will share their insights on the risk posed by these clinics to all stakeholders - the patients and their families, the practitioners and their professional indemnifiers, the academic, clinical and commercial sponsors developing legitimate products and the broader commercial milieu – particularly in the absence of demonstrable benefit. The presenters will also discuss how patient and clinician autonomy in the current environment is out of step with the basic science and the potential risks with these practices.


Learning Objectives:

  • To understand the current legislative framework permitting unproven cell-based therapies provided under medical exemption in Australia with a comparative analysis of frameworks in the US, EU, and Japan.

  • To understand specific concerns with the Australian and Japanese situation and the current commercial activity in both markets in unproven treatments provided by “stem cell clinics” and in promoted “trials”.

  • To consider the medico-ethical issues with the marketing of these treatments by medical practitioners and their scope of professional practice.

 

Registration Deadline: Tuesday, October 18, 2016
Members: $105; Non-Members: $120

Register Online


If you cannot attend the live webinar, consider purchasing the digital recording. This allows access to a recording of the audio and slides of the live presentation at your convenience. CLICK HERE to purchase digital recordings of past webinars.

**Please note that we are unable to offer refunds or cancellations.

IMPORTANT: While we do not support toll-free operator assisted lines for International (non-US/Canada) registrants, we offer BROADCAST AUDIO, eliminating the need to listen over the phone. Register for the webinar and support your own long distance charges, please proceed with registration and we will provide you with a toll number for your location. As an alternative option, you may purchase the webinar as a digital recording.

After the webinar and upon completion of the post-webinar survey, participants will now receive a link to the audio recording of the webinar as well as CMLE credits. Each webinar registration includes one credit hour for the registered participant upon completion of the post-webinar survey. There are no CMLE credits provided with digital recording purchases.

Should you have further questions about this event, please email isct@celltherapysociety.org or call 604-874-4366.
Click here to learn more about ISCT webinars.


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