MEETINGS, WEBINARS AND SYMPOSIA
CAPRA Dinner Meetings, Webinars and Symposia Schedule
Thursday, February 14
|Regulatory Review of Drugs & Devices (R2D2) – Accelerated Pathway & New Device Guidances Workshop
CAPRA will host a one day consultation workshop for Health Canada to provide an update and receive feedback on new initiatives. Concurrent workshop & feedback sessions will be held for the following topics.
- Significant changes to the Priority Review Pathway under R2D2 called the Accelerated Review Pathway will be 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, will be discussed with respect to the mitigation and/or elimination of risk to patients due to cybersecurity vulnerabilities in medical devices. Specific topics will include:
- Health Canada’s planned regulatory approach to medical device cybersecurity;
- relevant standards when designing, manufacturing and testing medical devices and
- license application changes.
The event will be of interest to:
- Regulatory Affairs professionals;
- Market Access professionals in relation to patient benefit;
- Medical device software subject matter experts.
Please share the news of this event within your organization.
Registration will be open December 12, 2018 to February 7, 2019.
Click here for the brochure.
Click here to register.