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Regulatory Roundup

Thursday, February 16, 2023 (9:00 AM - 12:30 PM) (EST)

Description


Join us for our virtual Regulatory Roundup, designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry. The agenda includes comprehensive presentations by CDRH, industry representatives and regulatory experts. 

We are thrilled to welcome our keynote speaker, Dr. Suzanne Schwartz, Director of the Office of Strategic Partnerships and Technology Innovation, CDRH. Dr. Schwartz's team is tasked with providing our industry with leadership and strategic direction on medical device cybersecurity, software, and digital health.

FREE REGISTRATION!


AGENDA

9:00 – 9:45 AM
Destination, Switzerland? The Impact of the Recent Decision of the Swiss Parliament on Medical Devices with FDA Authorization


Switzerland's Parliament has recently decided to mandate the Swiss government to adapt the national law so that in the future medical devices with FDA Authorization will be recognized in Switzerland in addition to CE-marked medical devices. Joining us from Switzerland’s association of medical technology, Swiss Medtech, is Sandra Rickenbacher-Läuchli, Head of Public Affairs & Legal Counsel, Member of the Executive Board, to discuss this pioneering decision. Sandra will speak about the implementation of the decision, the way forward as well as discuss potential impacts for global and domestic companies moving forward.

9:45 – 10:30 AM
Navigating MDR Today and Tomorrow

This interactive presentation will provide you with an overview of the latest updates on MDR in the EU, including the impact to global medical device regulatory developments due to the proposed transition period for compliance. Join us to hear what will happen next for MDR and how you can best navigate the evolving global regulatory environment.

10:30 – 11:00 AM
FDA Priorities for 2023

11:00 – 11:20 AM
Recent Developments on the “Fraud on the FDA” Theory of False Claim Liability

Rick Ball and Coleen Hill from Duane Morris will provide an overview of a theory of liability for pleading claims under the False Claims Act commonly referred to as “Fraud on the FDA.” They will discuss what risks such a theory might pose and delve into how various federal courts have recently accepted or rejected claims based on this theory.  

11:20 – 11:45 AM
Cybersecurity Best Practices for Regulated Medical Devices

11:45 AM – 12:30 PM
Keynote Presentation & Q&A - Dr. Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
 

This session will provide an overview of the latest updates from CDRH’s Office of Strategic Partnerships and Technology, with a specific focus on digital health and cybersecurity. This briefing will be followed by a moderated Q&A session led by Amra Racic of Veeva Systems where you will get the chance to ask your questions directly to Dr. Schwartz!



SPEAKERS

Dr. Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA

Dr. Suzanne Schwartz MD, MBA, is the Director of the Office of Strategic Partnerships and Technology Innovation at FDA’s Center for Devices and Radiological Health (CDRH). Schwartz’s work in medical device cybersecurity includes raising awareness, educating, outreach, policy development, partnering and coalition-building within the healthcare and public health sector (HPH) as well as fostering collaborations across other government agencies and the private sector. Schwartz has been recognized for Excellence in Innovation at FDA’s Women’s History Month for her work in medical device cybersecurity. Schwartz chairs CDRH’s Cybersecurity Working Group. She also co-chairs the Government Coordinating Council for the HPH Critical Infrastructure Sector, focusing on the sector’s healthcare cyber-initiatives.



Fredrick Ball, Partner, Duane Morris

Frederick (Rick) R. Ball focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris 
Life Sciences and Medical Technologies industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation.   Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal. 


Joe Dawson, Principal Software Security Analyst, Intertek EWA-Canada


Joe Dawson is a Principal Software Security Analyst for Intertek EWA-Canada based in St. John's, Newfoundland. Joe has more than 30 years' experience in Software Development, Data Communications, and Information Security, in both the public and private sectors. He currently sits on the Standards Technical Panels for all the UL 2900 family of standards and sits on one of the IEC 62443 standards committees. 

 


Ainoa Forteza, Associate Director, Regulatory Affairs, Aliria Health

Ainoa is the leader of the Regulatory Medtech Group of Alira Health. She has over eight years of experience in Regulatory Affairs consultancy. As part of these years, Ainoa worked at Drug Development and Regulation S.L. (DDR), currently Veristat, where she was in charge of DDR’s team responsible for Medical Devices and In Vitro Diagnostics, contributing to these products’ strategy to obtain the CE mark while making sure the manufacturer complies with the Medical Devices and In Vitro Diagnostics Regulation (MDR and IVDR). Ainoa is a Human Biologist (Pompeu Fabra University) who also holds a Master on Pharmaceutical and Biotechnology Industry (Pompeu Fabra University) and a Postgradute on Expert on Medical Devices (University of Barcelona).


Coleen Hill, Associate, Duane Morris

Coleen Hill is a trial attorney representing clients in the life sciences industry in complex commercial disputes. She holds a leadership role in Duane Morris’ Life Sciences and Medical Technologies Industry Group. In addition, she helps pharmaceutical companies, biologics manufacturers, medical device manufacturers and pharmacies navigate the complex challenges faced by state and federal regulation for their industries. 


Amra Racic, Senior Director, Government Strategy, Veeva Systems


As Senior Director of Government Affairs at Veeva Systems, Amra is responsible for understanding the challenges and opportunities of medtech companies as well as representing the company in major industry associations to help foster industry progression.  She has more than 23 years of experience in the Healthcare Industry, most of which were in large Medical Device companies in a variety of regulatory roles. Most recently, Amra led Regulatory Intelligence activities for Abbott’s Medical Device Division where her team was responsible for receiving, analyzing, and interpreting regulations that had the potential of impacting Abbott or wider industry. Prior to Abbott, Amra held leadership roles across regulatory, clinical, and quality at Bayer and Medtronic.  She has also represented the medical device industry in various association working groups include Advamed, RAPS, WHO, IMDRF, and the FDA.   


Sandra Rickenbacher-Lächli, Head of Public Affairs & Legal Counsel, Member of the Executive Board, Swiss Medtech

Sandra Rickenbacher studied law at the University of Zurich, Switzerland, is a attorney-at-law and holds an LL.M. in European Law from the College of Europe in Brugge, Belgium. Sandra Rickenbacher has been working in the position as Head of Public Affairs and Legal Counsel, Member of the Executive Board, for Swiss Medtech, the association of Swiss medical technology, since September 2021. Before, she had worked for the Federal Department of Economic Affairs and subsequently for the Federal Department of the Environment, Transport, Energy and Communica-tions for more than ten years – in both Departments (“Ministries”) in the position as personal advisor to the respective member of the Swiss government. In previous functions, she held positions in the energy and the financial sectors.



George Strom, Business Development Director of IOT, Intertek


George Strom is Business Development Director of IOT at Intertek, a FTSE 100 Company.  George has worked with medical device manufacturers around the world to help them meet all of their assurance, testing, inspection, and certification needs.   George’s 20+ years in the Quality Assurance & Safety arena bring insight into the unique challenges of launching a product in today’s Connected World. Prior to Intertek, George worked in Sales and Marketing within the Computer & Office Automation Industry.  He is a proud alumnus of U-Mass Lowell and lives in the Greater Boston Area. 

 



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Thursday, February 16, 2023 (9:00 AM - 12:30 PM) (EST)
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