Main Conference Sessions Agenda: Day 2

THURSDAY, MAY 2, 2019

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the globe as we kick off the second day of MedCon with a complimentary warm breakfast.


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8:30 AM - 8:40 AM

Day 2 Opening

Participants will feel the Xavier Difference at MedCon, a purpose-driven, action-oriented conference. We will start the day recapping the take away points from Day 1 through the Act-Change-Transfer process with a focus on “action.”

Moderator:

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

Speaker: 

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


8:40 AM - 9:55 AM

FDA Pre and PostMarket Update

CDRH is taking a TOTAL Product Lifecycle approach to decisions they make about your product, folding in real world evidence to PreMarket and Post Market Approvals, and working to assess the maturity of your company. Learn directly from FDA how they are increasing speed to market, and don't miss this opprotunity to stay abreast of Pre and PostMarket priorities.

Moderator:

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

Speakers:

  • CAPT Sean M. Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, FDA-CDRH

  • Joshua Nipper, Director, PMA & HDE Programs Program Operations Staff Office of Device Evaluation, FDA-CDRH


9:55 AM - 10:15 AM

Break


10:15 AM - 12:10 PM

Day 2 Tracks, Part 1

  1. International Track

EU MDR: Successful Practices for Technical Hurdles

With limited time for transition into the new EU MDR and IVDR legislation, a right first time approach is more important than ever for the accuracy and completeness of your technical documentation.  Experts will provide insight on how to link the numerous plans and reports required through the new structure, as well as practical solutions for preparing clinical evaluation and clinical utility reports.  A key challenge to overcome will be to continuously update risk-based assumptions, and providing feedback loops for pre-market and post-market operations.  Don't miss this opportunity to set your company up for continuous regulatory compliance.

Moderator:

  • Gert Bos, Executive Director & Partner, Qserve Group

Speakers:

  • Robyn Meurant, Executive Director, Regulatory Team, IVDs and Medical Devices, NSF International

  • Reynaldo R. Rodriguez, Jr., Director, Quality Systems and Business Support, Abbott Quality and Regulatory, Abbott Laboratories

  • Hugo Xi, M.D., M.B.A., Director, Medical Affairs, Abbott Quality & Regulatory, Abbott Laboratories

2. POSTMarket Track

Successfully Navigate the Medical Device Recalls Process: An Interactive Case Study

Do you want to improve your ability to prepare an “806 package” and better understand what FDA does when it receives information you submitted? This session will include an interactive case study that will walk participants through that process from start to finish. You will complete a mock 806 report, and engage with speakers to understand how FDA evaluates and classifies the risk posed by the device. Participants will also discuss best practices to ensure submission of complete status reports and all necessary information to successfully terminate the recall.

Moderator:

  • Gina Brackett, Director Compliance Branch, FDA-ORA

Speakers:

  • Shumaya Ali, Assistant Director in the Division of Restorative, Repair and Trauma Devices, Office of Health Technology 6 (Orthopedic Devices), Office of Product Evaluation and Quality, FDA-CDRH

  • Meredith Andress, OMDRHO Division 2 Recall Coordinator, FDA

  • Cynthia Aycock, OMDRHO Division 1 Recall Coordinator, FDA

  • Andrew Lang, OMDRHO Division 1 Recall Coordinator, FDA

  • Melinda Ruiz, OMDRHO Division 1 Recall Coordinator, FDA

3. DIGITAL Health Track

Navigating the Challenges of Digital Health Innovation

Digital health applications, especially those incorporating artificial intelligence, machine learning and Real World Evidence, demand unique considerations in design, regulatory evaluation, and marketing. Hear FDA's latest thinking on digital health innovation and regulatory initiatives for digital health applications, including FDA’s newly released discussion paper and request for feedback on its Proposed Regulatory Framework for Modifications to Artificial Intelligence/ Machine Learning Based SaMDs and the Software as Medical Device pre-certification pilot. Learn from industry experts how to navigate the challenges of developing digital health applications, build quality into the development process, and understand the regulations governing innovative software applications. Hear the medical app developer's perspective from real life experiences in first-time development of a regulated medical app. Our panel of experts will discuss the latest hot topics in digital health and how FDA, the industry, and you rise to meet the challenges.

Moderator:

  • Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH

Speakers:

  • Matthew Diamond, MD, Ph.D., Medical Officer, Digital Health, Office of Strategic Partnerships and Technology Innovation, FDA-CDRH

  • Barbara Fant, President and Principal Regulatory Consultant, Clinical Research Consultants, Inc.

  • Hylton Kalvaria, Vice President, Strategic Partnerships, Verana Health

  • Bernhard Kappe, Founder and CEO, Orthogonal

  • Rama K. Pidaparti, AVP, QARA - Medical Devices & Life Sciences, L&T Technology Services


12:10 PM - 1:25 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:

  • EU MDR

  • Device Recalls Process

  • Digital Health Innovation


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1:25 PM - 2:25 PM

Day 2 Tracks, Part 2

  1. INTERNATIONAL Track

EU MDR: Successful Practices for Procedural Hurdles

Keep your medical devices on the EU market by being prepared for the unknowns and unexploited!  Quite a few of the EU MDR changes require further guidance to clearly understand what is needed, e.g. UDI, risk management on cosmetic devices, registration in a yet to be built EUDAMED database system, and much more. But the legislation also forces manufacturers to use guidance and common specifications once published, follow additional law that will come in form of delegated acts, and above all to make sure that all documentation consistently meets the rapidly changing requirements. Experts will share how you can do the impossible: prepare for the unknowns!

Moderator: 

  • Gert Bos, Executive Director & Partner, Qserve Group

Speaker: 

  • Phil Desjardins, VP, Global Regulatory Policy & Intelligence, Johnson & Johnson

  • Mindy McCann, US VP Regulatory Compliance, Qserve Group

2. POSTMARKET Track

Changes to Marketed Product: Keeping Pace With Your Product Lifecycle

Be prepared to support the success of your patients by maintaining exceptional products on the market that continue to support their health and well-being. You will gain a deeper understanding of how to most effectively navigate the regulatory process so your product changes can reach the market at a pace that keeps up with innovation. Expert leaders will share how to balance speed, assessment of design creep, and the impact of the sum of changes. Don't miss this hands-on opportunity to gain insightful lessons learned that you can apply today.

Moderator:

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

Speakers:

  • Brad Hauser, Vice President, R&D and General Manager, CoolSculpting

  • Ruth James, Senior Program Lead, Regulatory Affairs, Ethicon Endo-Surgery

3. DIGITAL HEALTH Track

The Business of Innovation

You have an idea for a novel device or digital health technology. There is nothing like it on the market, nothing to compare it to.  Learn how to navigate unique financial, manufacturing, and regulatory challenges for breakthrough devices and innovative technology. Experts from across the product lifecycle will share insightful lessons learned that you can apply today. 

Moderators:

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

Speakers: 

  • Vanessa Barth, Chief Scientific Officer, BioCrossroads (on-loan executive from Eli Lilly)

  • Matthew Diamond, MD, Ph.D., Medical Officer, Digital Health, Office of Strategic Partnerships and Technology Innovation, FDA-CDRH

  • Barbara Fant, President and Principal Regulatory Consultant, Clinical Research Consultants, Inc.

  • Jason Heikenfeld, Vice President for Commercialization, University of Cincinnati (also founder and CTO for Eccrine Systems)

  • Hylton Kalvaria, Vice President of Strategic Partnerships, Verana Health

  • Bernhard Kappe, Founder and CEO, Orthogonal

  • Jim Prodafikas, Worldwide Director Market Access and Reimbursement - Diabetes Care, BD

  • Harikrishnan Ramaraju, Regional Lead - Medical Devices & Life Sciences, L&T Technology Services


2:25 pm - 2:45 pm

Relocation Break

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


2:45 pm - 2:55 pm

Focus on Learning

Participants will assess their key learnings through the Act-Change-Transfer process with a focus on “change.”

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


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2:55 pm - 3:55 pm

FDARA Impacts You!

Several changes are coming as a result of the Food and Drug Administration Reauthorization Act (FDARA) of 2017. Are you aware of what they are and how they will impact your company? FDA and Industry panelists will discuss FDARA provisions related to the inspection planning process. Specifically, FDA is required to provide additional visibility on the type, nature and expected duration of the inspection. There is a new process for seeking non-binding feedback for certain inspectional observations and changes to the process for issuing certificates for foreign government.

Moderator: 

  • CAPT Sean M. Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, FDA-CDRH

Speakers: 

  • Gina Brackett, Director Compliance Branch, FDA-ORA

  • Amanda Klingler, Partner, FDA and Life Sciences Practice, King & Spalding

  • Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott


3:55 pm - 5:00 pm

Chief Quality Officers - Redesigning the Field of Quality for the 21st Century

Quality Leaders across the pharmaceutical, medical device, consumer goods and animal health industries are collaborating on leading-edge solutions that drive the future of the industry with and for all stakeholders. As these leaders work to Create Quality for the 21st Century, engage on how the role of Quality can be shifted to one that optimizes patient health and business success by mobilizing enterprise-wide quality effectiveness through innovative systems and critical thinking grounded in science, data, stakeholder awareness and regulatory intelligence. Walk away inspired to become part of the path forward!

Moderator: 

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers: 

  • Georges France, VP LOCs & Global Quality Lead, GSK

  • Corlis Murray, Senior Vice President, Quality Assurance, Regulatory and Engineering Services, Abbott

  • Brian Schultz, Vice President of Quality and Regulatory Affairs, Fisher & Paykel

  • Peter Shearstone, Vice President, Global Quality Assurance and Regulatory Affairs, Thermo Fisher Scientific


5:00 PM - 7:00 PM

Networking Reception

After the conference sessions on Thursday, benefit from open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with Strategic Committee members and speakers in a pleasant, informal setting.