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The Regulatory Roadmap for Medical Devices
November 10, 2016 @ 11:00 am - 1:30 pm
Regulatory and compliance requirements for medical devices can sometimes feel like a moving target. The regulatory function in the healthcare industry is critical in order to make safe and effective products available worldwide. What can you do to stay ahead of the curve when it comes to FDA and Health Canada submissions?
Learn about FDA and Health Canada regulatory requirements, specifically FDA processes (Section 510(k) clearances, Premarket Approval (PMA), and Combination Products) and Health Canada’s medical device licensing requirements. This session will help you pinpoint the information you need to develop a regulatory strategy, and then hit the ground running. Learn the next steps you need to take to bring your device to market.
Don’t miss the opportunity to apply for a one-on-one meeting with our experts to further discuss your company and your personal path to regulatory success.
11:00 AM | Registration Opens
11:30 AM | Presentations
12:30 PM | Q&A
1:00 PM | Lunch and Networking
1:30-5:00 PM | One-on-one Meetings*
*Companies must have applied for a one-on-one meeting ahead of time and been approved. The application period ends on October 10th, 2016.
Young Kim | Director of Regulatory Affairs, Johnson & Johnson Medical Companies read bio»
Sharon Starowicz | Director, Regulatory Policy Innovation, Global Orthopaedics, Johnson & Johnson read bio»
Presentation & Lunch
CA$ 40 | General Public
CA$ 25 | Student/Academic
CA$ 50 | At the door
Includes presentation, Q&A, and lunch. All attendees must pay this fee, regardless of one-on-one meeting status. Registration to attend the presentation, Q&A, and lunch will remain open until noon on Nov 9, 2016 (or sold out).
FREE | Application
FREE | Accepted Companies
Companies must have applied for a one-on-one meeting ahead of time. The one-on-one application period ends on October 10th, 2016. Your application will be reviewed and you will be notified of acceptance by email on October 28th, 2016. Acceptance of a one-on-one meeting is not guaranteed as all applications must be approved.
JLABS @ Toronto
IBM Canada Offices
3600 Steeles Avenue East, Room D109