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The Regulatory Roadmap for Medical Devices

April 7, 2016 @ 11:00 am - 1:00 pm

Free – $45

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 submissions and protocols?

Learn about FDA Section 510(k) clearances, the Premarket Approval (PMA) and Biologics License Applications (BLA) processes. 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.

Sharon Starowicz from Johnson & Johnson’s Orthopedics business and Raina Dauria from Ethicon BioSurgery have a combined 50 of years of experience in the medical device regulatory field.

Don’t miss the opportunity to apply for a 1-on-1 meeting with Raina as a forum to further discuss your company and your personal path to regulatory success.

11:00am | Registration Opens, Lunch, and Networking
11:30am | Presentations
12:30pm | Q&A
1:00pm | Program Close
1:30-5:00pm | 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 March 17th, 2016.

Raina Dauria | Senior Director, Regulatory Affairs, Ethicon BioSurgery, Johnson & Johnsonread bio»
Sharon Starowicz | Director, Regulatory Policy Innovation, Global Orthopaedics, Johnson & Johnson read bio»

Presentation & Lunch
$35  | General Public
$20  | Student/Academic
$45  | 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 April 6, 2016 (or sold out).

One-on-One Meeting
FREE | Application
FREE | Accepted Companies
Companies must have applied for a one-on-one meeting ahead of time. The one-on-one application period ended on March 17th, 2016. Your application will be reviewed and you will be notified of acceptance by email on March 28th, 2016. Acceptance of a one-on-one meeting is not guaranteed as all applications must be approved. 


April 7, 2016
11:00 am - 1:00 pm
Free – $45


Microsoft NERD Center
1 Memorial Dr #1
+ Google Map

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