MedCon Agenda: Day 1
Wednesday, May 2, 2018

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the globe 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), Director, Xavier Health, Xavier University

Speakers:

  • Marla Phillips
  • Steven Barber, Cincinnati District Director, FDA
  • Joe Matrisciano, Divisional Director, Office of Medical Device and Radiological Health Operations, Division 1, FDA-ORA


IMG_3042_rev.jpg

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, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices

Speaker:

  • Dennis Hahn

9:45 AM - 10:05 AM

Break


10:05AM - 10:50AM

Center Director Corner: Strategic Priorities for 2018 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, Professor, University of Cincinnati, College of Law

Speaker:

  • Jeff Shuren, Director of the Center for Devices and Radiological Health, FDA (remote)

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, Lead Quality System & Compliance Consultant, King & Spalding

Speakers:

  • Amanda Klingler, Partner, FDA and Life Sciences Practice, King & Spalding
  • Steve Niedelman
  • James O’Reilly, Professor, University of Cincinnati, College of Law

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 on these topics:

  • Corrections and Removals
  • Digital Health
  • The PMA Process

12:35 PM - 2:40 PM

Day 1 Tracks, Part 1

1a. 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, Director, Regulatory Affairs, STERIS

Speakers

  • Maureen Dreher, Ph.D., Biomedical Engineer, FDA (remote)
  • Vineet Erasala, Chief Operations Officer, Genetesis
  • Audrey Munnerlyn, Senior Director, Regulatory Affairs, Johnson & Johnson Vision
  • Caroline Rhim, Ph.D., Executive Director, NSF International

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

Streamlining the PMA Process: PreMarket Approval (PMA) is the most stringent type of device marketing application required by CDRH/FDA.  A PMA submission requires sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s); manufacturing information/data; a satisfactory 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 CDRH initiatives aimed at streamlining this process, including organizational improvements, the Breakthrough Devices Program,  and the Voluntary Medical Device Manufacturing and Product Quality Program.

Moderator:

  • Steve Binion, Ph.D., M.B.A., Sr. Director, Regulatory Policy
    Corporate Regulatory Affairs, BD

Speakers:

  • Barbara S. Fant, Pharm.D., President, Clinical Research Consultants, Inc.
  • Joshua Nipper, Chief of Premarket Approval Staff, Office of Device Evaluation, FDA-CDRH (remote)
  • Steve Silverman, J.D., Vice President, Technology and Regulatory Affairs, AdvaMed
     

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

FDA Rethinks Handling of Corrections & Removals, Allegations, and 483 Responses (Part 1): Do you know how benefit and risk inform FDA’s evaluations of corrections and removals, allegations, and 483 responses? Are you aware that FDA is substantially rethinking its approach, and formally incorporating the factors outlined in its recent postmarket benefit-risk guidance document? FDA and Industry experts will briefly overview the guidance and the benefit-risk factors in Part 1 of this session, and then providing deeper perspectives from CDRH, ORA, and industry on how these factors can change current practice. Overarching concepts and decision aids will be demonstrated and discussed by panelists, while engaging participants in roundtable discussions. The FDA and Industry experts will then continue to engage attendees by using case studies in Part 2 of this session to illustrate how today’s reports of corrections and removals, allegations, and 483 responses might be managed differently both by FDA and industry in the future. 

Moderator:

  • Susan Rolih, Executive Vice President, Regulatory and Quality Systems, Meridian Bioscience, Inc.

Speakers:

  • Pat Baird, Regulatory Head of Global Software Standards, Philips
  • Gina Brackett, Director Compliance Branch, FDA
  • Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH
     

3. Digital Health Track (12:35pm - 2:40pm)

Digital Health Innovation...The Future is Now: Digital health is transforming our daily lives. Hear FDA’s latest initiatives in digital health innovation, cybersecurity, and Software as Medical Device pre-certification. Learn from industry how to navigate the challenge of regulatory compliance for third party hosting services, and qualification of a software based medical device development tool. Our panel of experts will discuss the latest hot topics in digital health and how FDA and industry rises to meet the challenges.

Moderators: 

  • Francis Blacha, Global Quality Leader - Drug Delivery System Development, Eli Lilly
  • Lenore Faulhaber, Principal Scientist, P&G
  • Barbara Fant, President and Principal Regulatory Consultant, Clinical Research Consultants, Inc.

Speakers: 

  • Carl Kraenzel, Vice President & Distinguished Engineer, Chief Information Security Officer, IBM Watson Health
  • Joshua Lloyd, Director of Operations, OptoQuest
  • Murali Mani, Director of Compliance, IBM Watson Health
  • Bakul Patel, Associate Center Director for Digital Health, FDA-CDRH


2:40 PM - 3:00 PM

Break


IMG_2973_rev.jpg

3:00 PM - 4:00 PM

Day 1 Tracks, Part 2

1. 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.

Moderator

  • Francis Blacha, Global Quality Leader – Drug Delivery System Development, Eli Lilly

Speakers

  • Paul Coplan, ScD, MBA, FISPE, Vice President, Head of Medical Device Epidemiology, Johnson & Johnson
  • Rachel Rath, Deputy Director, National Evaluation System for Health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC)

 

2. PostMarket Track

FDA Rethinks Handling of Corrections & Removals, Allegations, and 483 Responses (Part 2): Do you know how benefit and risk inform FDA’s evaluations of corrections and removals, allegations, and 483 responses? Are you aware that FDA is substantially rethinking its approach, and formally incorporating the factors outlined in its recent postmarket benefit-risk guidance document? FDA and Industry experts will briefly overview the guidance and the benefit-risk factors in Part 1 of this session, and then providing deeper perspectives from CDRH, ORA, and industry on how these factors can change current practice. Overarching concepts and decision aids will be demonstrated and discussed by panelists, while engaging participants in roundtable discussions. The FDA and Industry experts will then continue to engage attendees by using case studies in Part 2 of this session to illustrate how today’s reports of corrections and removals, allegations, and 483 responses might be managed differently both by FDA and industry in the future. 

Moderator:

  • Susan Rolih, Executive Vice President, Regulatory and Quality Systems, Meridian Bioscience, Inc.

Speakers:

  • Pat Baird, Regulatory Head of Global Software Standards, Philips
  • Gina Brackett, Director Compliance Branch, FDA
  • Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH

3. 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, Executive Vice President, Medical Device International Services, NSF International

Speakers:

  • Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF International
  • Scott Sardeson, International Regulatory Affairs and Quality Compliance Leader, 3M


4:00 PM - 4:10 PM

Break

Participants are invited to use this time to return to the plenary session held in the main conference room.


4:10 PM - 5:00 PM

How Best to Interact with CDRH—Premarket and Postmarket

Providing timely and effective responses to FDA-483’s and Warning Letters can be critical to avoiding subsequent enforcement action by FDA such as corporate-wide warning letters, seizure, injunction, civil money penalties and even prosecution. Responses must be clear, concise, address the finding systemically, as well as the specific example cited and provide objective evidence to document changes being made. 

During this session you will learn:

  • What steps you can take to minimize the risk of FDA taking “next steps” toward further action. 
  • The importance of the FDA closeout meeting with management at the conclusion of the inspection, who should be present, the importance of clarifying any errors or misconceptions, understanding investigator suggestions and recommendations.
  • The importance and criticality of creating a cross functional team to immediately dissect the observations and begin preparing responses.
  • Common pitfalls to avoid in preparing your responses.

Moderator:

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

Speakers:

  • Steve Niedelman
  • Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products (Vice President Regulatory Affairs, MDMA), Greenleaf Health

5:45 PM - 8:30 PM

Annual MedCon Dinner – The American Sign Museum

american-sign-museum.jpg

Network with FDA, speakers, committee members and peers, while touring America’s largest public sign museum. The museum’s collection is sure to spark thoughts of art, history, and fond memories. The informal atmosphere is the perfect place to continue conversation from the day’s sessions or start new ones. The evening will be capped with a dinner in the museum’s community room.