CAPRA R2D2 Workshop Audio/Presentations

Audio/Presentations for CAPRA Workshop

Here is your opportunity to purchase the presentations with audio in PDF/MP3 format from the CAPRA R2D2 – Accelerated Pathway & New Device Guidances Workshop

R2D2 – Accelerated Pathway & New Device Guidances Workshop

February 14, 2019 – Toronto

CAPRA hosted a one-day consultation workshop for Health Canada to provide an update and receive feedback on new initiatives. Significant changes to the Priority Review Pathway under R2D2 called the Accelerated Review Pathway were discussed including: expanded product eligibility criteria for accelerated review; creation of conditions that will promote price competition and creation of a single accelerated review pathway, merging priority review and NOC/c streams.

New device guidances, Cybersecurity and Software as a Device, were discussed with respect to the mitigation and/or elimination of risk to patients due to cybersecurity vulnerabilities in medical devices. Specific topics included: Health Canada’s planned regulatory approach to medical device cybersecurity, relevant standards when designing, manufacturing and testing medical devices and license application changes.

Speaker

Topic

Michelle Remillard
Policy Analyst, Regulatory Review of Drugs & Devices

Accelerated pathway guidance

Laura King
Head of Regulatory Affairs Novartis Pharmaceuticals Canada

Accelerated Pathway Guidance Industry Perspective

Concurrent Session #1 – Drugs

Concurrent Session #2 – Medical Devices

Accelerated Pathway Guidance Workshop based on proposal and key questions

Cyber Security Guidance 
Ian Glasgow, Senior Evaluator, Digital Health Division, Medical Devices Bureau (MDB), TPD, HPFB

Accelerated Pathway Guidance Plenary Feedback 

 Software as a Medical Device Guidance 
Colin Foster, Head, Regulatory and Scientific Information Section, MDB, TPD, HPFB

Speaker

 Topic

Colin Foster, Head 
Regulatory and Scientific Information Section, Medical Devices Bureau, Therapeutic Products Directorate, HPFB

 Licensing of Medical Devices in Canada eLearning Training

 

Megan Bettle 
Director, Regulatory Review of Drugs and Devices, BGTD, HPFB

Update on other Regulatory Review of Drug and Device Projects
Panel Discussion/Q&A  
 Closing Remarks 

Audio Presentations

Set(s) of audio/presentations on USB $88.50 + tax
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Order will not be shipped until payment is received. Payment must be received by April 05, 2019.

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CAPRA
2425 Matheson Boulevard East
7th Floor, Suite 795
Mississauga, Ontario L4W 5K4

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