MedCon Agenda: Day 1
Wednesday, May 2, 2018

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the country as we kick off MedCon with a complimentary warm breakfast.


8:30 AM  -  9:00 AM

Let's Make a Difference!

Welcome to the Conference, welcome to Xavier University, and welcome to the Cincinnati District of the FDA. This purpose-driven conference will lead you to actionable learning and implementation plans.

Moderator:

  • Marla Phillips (Co-Chair), Xavier University

Speakers:

  • Marla Phillips
  • Gina Brackett, FDA-ORA (invited)
  • Joe Matrisciano, FDA-ORA (invited)

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9:00 AM - 9:45 AM

The Solution Xchange

Start your day with solutions! This fast-paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.

Moderator:

  • Dennis Hahn, Johnson & Johnson

Speakers:

  • Dennis Hahn

9:45 AM - 10:05 AM

Break


10:05AM - 10:50AM

Center Director Corner: Strategic Priorities for 2017 and Beyond

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH), will share strategic priorities related to protecting public health, including collaborative activities shared with industry on the balance of safety, efficacy, quality, access, and innovation. 

Moderator:

  • James O’Reilly, University of Cincinnati

Speakers:

  • Jeff Shuren, FDA-CDRH (invited)

10:50 AM - 11:35 AM

New Laws That Can Shut You Down if You Are Not Prepared

Money and new staff positions will be coming to FDAs CDRH in the next several years to fill some of its resource needs. This panel takes you inside the two major pieces of congressional action, the User Fee Law (FDARA) and the 21st Century Cures Act. Each was a long-debated compromise. This panel will explain how the law affects device firms and reduces your risk of a surprise when FDA rolls out the dual legislative mandates in 2018-2020.

Moderator:

  • Steve Niedelman, King & Spaulding

Speakers:

  • Amanda Klingler, King & Spaulding
  • Steve Niedelman
  • Jim O’Reilly, University of Cincinnati

11:35 AM - 12:35 PM

Lunch Networking by Topic

Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion.


12:30 PM - 2:40 PM
Premarket, Postmarket & International Tracks, Part 1

1. PostMarket Track (12:35pm - 2:40pm)

FDA Rethinks Corrections & Removals (Part 1): Do you know the current requirements for Part 806 Corrections and Removals as they apply to manufacturers, distributors and importers? Are you aware that FDA is substantially rethinking its approach to evaluating Corrections and Removals? Part 1 of this session will discuss current requirements for corrections and removals, and contrast them with proposals for modifying the Agency’s tools for evaluating and classifying them. Part 2 of this session will use case studies to demonstrate how today’s corrections and removals might be managed differently both by FDA and industry in the future. Case studies will also be used to demonstrate what might be appropriate ways for FDA to maintain oversight of market withdrawals and manufacturers to recognize stealth recalls.

Moderator:

  • Susan Rolih, Meridian

Speaker:

  • Adam Saltman, FDA-CDRH (invited)

 

2a. International (12:35pm - 1:35pm)

IMDRF, Regulatory Convergence, and Practical Implementation: Interactive panel discussion on the most up to date information and how industry can practically utilize the efforts of global regulatory convergence, through the efforts of the International Medical Device Regulators Forum (IMDRF).

Moderator:

  • Kim Trautman, NSF

Speakers:

  • Melissa Torres, FDA (invited)
  • Isaac Chang, FDA (invited)
  • Nancy Shadeed, Health Canada
  • Jackie Elkin, Medtronic

2b. International Track (1:35pm - 2:40pm)

China – Land of Opportunity and Challenges: Perhaps the most dynamic market in the world, China’s rapidly expanding economy and continuously evolving regulatory landscape represents opportunities and challenges to medical device innovators. This session will provide an overview of the evolving regulatory landscape in China and present case studies on successful practices.

Moderator

  • Dennis Hahn, Johnson & Johnson

Speaker:

  • Industry TBD

 

3a. PreMarket Track (12:35pm - 1:35pm)

How to Leverage the Pre-Submission Program: It has been four years since FDA’s institution of a more structured Pre-Submission Program. Come learn from FDA and a panel of industry experts on how the program is working. Get tips on what works and what does not, and get expert insight on how to effectively leverage the program for your next FDA submission.

Moderator:

  • Bill Brodbeck

Speakers

  • Dr. Soma Kalb, FDA-CDRH (invited)
  • Caroline Rhim, NSF
  • Industry TBD

3b. PreMarket Track (1:35pm - 2:40pm)

Streamlining the PMA Process: PreMarket Approval (PMA) is the most stringent type of device marketing application required by FDA.  A PMA submission requires sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s); manufacturing data; a preapproval facility inspection; preclinical and clinical data; and a user fee of $394k. Join FDA and Industry experts as they provide a current overview of PMAs and the novel programs FDA has implemented to streamline this process, including Expedited Access and the Critical to Quality Initiative.

Moderator:

  • Steve Binion, BD

Speakers:

  • Josh Nipper, FDA-CDRH (invited)
  • Industry TBD

2:40 PM - 3:00 PM

Break


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3:00 PM - 4:00 PM
Premarket, Postmarket & International Tracks, Part 2

1. PostMarket Track

FDA Rethinks Corrections & Removals (Part 2): Do you know the current requirements for Part 806 Corrections and Removals as they apply to manufacturers, distributors and importers?  Are you aware that FDA is substantially rethinking its approach to evaluating Corrections and Removals? Part 1 of this session will discuss current requirements for corrections and removals, and contrast them with proposals for modifying the Agency’s tools for evaluating and classifying them. Part 2 of this session will use case studies to demonstrate how today’s corrections and removals might be managed differently both by FDA and industry in the future. Case studies will also be used to demonstrate what might be appropriate ways for FDA to maintain oversight of market withdrawals and manufacturers to recognize stealth recalls.

Moderator:

  • Susan Rolih, Meridian

Speaker:

  • Adam Saltman, FDA - CDRH (invited)

 

2. International Track

Regulatory Convergence Strategies (ISO 13485).  Convergence is upon us.  It is critical that medical device manufacturers supplying the global marketplace understand the compounded effect of these converging changes across multiple regulatory jurisdictions.  Come away with a deeper understanding of these changes, how the will impact your organization and tools to plan and fine-tune your approach to compliance with ISO 13485:2016, MDSAP, EU MDR, EU IVDR and Brexit.

Moderator:

  • Kim Trautman, NSF

Speakers:

  • Brian Ludovico, NSF; Industry TBD

 

3. PreMarket Track

Leverage Real World Evidence for a Streamlined PreMarket Submission Process: The FDA, in cooperation with Duke-Margolis Center for Health Policy, is building the National Evaluation System for health Technology (NEST). NEST, a 2017 strategic priority for CDRH, is a national network designed to efficiently generate better evidence for medical device evaluation and regulatory decision-making at different stages of the medical device total product life cycle (TPLC). Postmarket collection of real-world evidence (RWE) could be used to support new and evolving product functions in a way that would expedite medical device market entry and subsequent expansion of device indications more efficiently. The Medical Device Innovation Consortium (MDIC) is serving as an independent coordinating center to oversee NEST operations. The MDIC has announced a Governing Committee comprised of stakeholder representatives, such as patients, clinicians, medical device industry, regulators, payers and government. NEST will be a federated virtual system for RWE generation composed of strategic alliances among data sources including registries, electronic health records, payer claims, and other sources. Learn how to leverage RWE for your future submissions.

Moderators