MedCon Conference Sessions Agenda: Day 3

FRIDAY, MAY 3, 2019

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the globe as we begin the last day of MedCon with a complimentary warm breakfast.


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8:30 AM - 8:50 AM    

We do not learn from experience…we learn from reflecting on experience.
— John Dewey

To Your Success!

Advance your organization by preparing key action plans that will make a difference for you, your organization and the patients you serve.

Moderator:

  • Dennis Hahn, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices

Speaker:

  • Dennis Hahn, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices


8:50 AM - 10:20 AM    

Ask the Notified Body: EU MDR Insights

As you strive to mobilize your organization around the vast changes of the new EU Medical Device Regulations such that your valued products can continue to reach the patients and consumers who are depending on you, don't miss this rare opportunity to "Ask the Notified Body" critical questions related to their preparedness, your preparedness and crucial steps to take to keep your product on the market. The Notified Bodies are your gateway to market access and are vital to ensuring your product and market strategies are set for success. Learn firsthand how they are planning to manage the workload, where they are setting their priorities, how you can capture their attention, and what they are hearing on the inside.

Moderator:

  • Gert Bos, Executive Director & Partner, Qserve Group

Speakers:

  • Notified Bodies TBA


10:20 AM - 10:40 AM

Break


10:40 AM - 12:10 AM

FDA Inspections: Demystifying the Process of What Happens Before and After Your Inspection

Do you know why FDA chose your firm to be inspected, and what happens within the FDA after that inspection?  Hear directly from a panel of directors from ORA's Office of Medical Device and Radiological Health Operations (OMDRHO) and CDRH to understand the internal FDA process.  Don't miss this rare opportunity to  gain a first-hand glimpse of criteria FDA use for risk-based decisions on who to inspect, how your inspection report is reviewed, and by whom.  Will your company be next?

Moderator:

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

Speakers:

  • Gina Brackett, OMDRHO Division 1 Director, Compliance Branch, FDA (invited)

  • Arduino Frankovic, OMDRHO Division 1 Director, Investigations Branch, FDA (invited)

  • Melissa Michurski, OMDRHO Division 2 Director, Compliance Branch, FDA (invited)

  • FDA TBA


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12:10 AM - 12:15 PM

To Your Success!

Thank you for joining us! We look forward to advancing the industry with you throughout the year as you implement the successful practices you learned at MedCon 2019!

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speaker:

  • Marla Phillips, Director, Xavier Health, Xavier University