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Regulatory Roundup

Wednesday, November 15, 2023 (8:00 AM - 4:15 PM) (EST)

Description

Join us for our Regulatory Roundup, designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry.

In-person or virtual tickets are available.

We will provide a Uniform Certificate of Attendance for in-person attendees should you wish to apply for continuing education units (CEU).

AGENDA

8:00 - 8:05 am	Opening Remarks
8:05 - 8:50 am	Recent Developments on the 510(k) Front: A Deep Dive into FDA’s Recently Issued Draft Guidance on Predicate Device Selection	The Center for Devices and Radiological Health (CDRH) recently issued three draft guidance documents aimed at modernizing the 510(k) program, one of which proposes a significant shift in the process for identifying predicate devices for a substantial equivalence comparison. This session will explore the potential legal, regulatory, and practical implications of the recommendations set forth in the draft guidance, including its potential impact on companies that will be submitting 510(k)s for new devices or for modifications to previously cleared devices. Presented by: Covington
8:50 - 9:35 am	Regulatory Considerations of the Chemical Characterization and Material Selection of Medical Devices	In today's rapidly evolving landscape, the selection and characterization of materials play a pivotal role in ensuring the success of diverse applications including medical devices. Material choices can create unique challenges for bringing a devices successfully through the regulatory process. Attendees will gain valuable insights into the evolving field of materials science, discover best practices for selecting and characterizing materials, and gain a deeper understanding of how these choices may impact their devices. The discussion will also consider the regulatory implications of the material selection and material characterization processes. Presented by: RQM+
9:35 - 10:00 am	Networking Break
10:00 - 10:45 am	Hearing From the Front Lines	Featuring three OEM regulatory professionals living regulatory challenges daily, and moderated by a regulatory thought leader, this roundtable discussion will highlight the pain points and opportunities those working on the "front lines" are experiencing, including best practices and lessons learned.
10:45 - 11:45 am	FDA Keynote & Moderated Q&A	This session will provide a keynote address from the newly appointed Director of the Digital Health Center of Excellence at the Center for Devices and Radiological Health, FDA, Troy Tazbaz. This will be followed by a moderated Q&A session led by Veeva MedTech where you will get the chance to ask your questions directly to Troy! Presented by Veeva MedTech
11:45 am - 12:45 pm	Lunch & Networking
12:45 - 1:15 pm	Fireside Chat with Becton, Dickinson and Company (BD)	In this session, we will hear from Brian Blonowicz, Sr. Regulatory Affairs Manager at BD about how digital health is transforming their daily work. We will also touch on how they are evolving to meet continued changes in this space and uncover best practices for collaboration with industry peers. Presented by Veeva MedTech
1:15 - 2:00 pm	GenAI is Here - How Medtech Companies Can Leverage These Capabilities to Transform Their Regulatory and Quality Functions	Artificial Intelligence, Machine Learning and Large Language Models (also known as Generative AI) is here. This session will talk about how MedTech can deploy these capabilities to transform their regulatory and quality functions. Session presenters will also discuss several practical examples that companies can start deploying now. Presented by: KPMG
2:00 - 2:30 pm	ARPA-H Investor Catalyst Hub Update	This session will provide an update on the latest developments with ARPA-H Investor Catalyst Hub, what it means for our region and how to engage.
2:30 - 3:00 pm	Networking Break
3:00 - 3:45 pm	Evolving "Considerations" of EMC and Cybersecurity with Medical Devices	There are two significant “Considerations” in medical device compliance that are impacting device manufacturers today – and causing some questions when it comes to their FDA submissions. First is the Technical Report 60601-4-2 which is EMC Immunity-related and refers to a product’s intended use. The second is the Refuse to Accept policy for cyber devices and related systems (in effect October 1, 2023). This guidance sets expectations that premarket submissions should take into account cybersecurity requirements or risk not being accepted by the FDA. Presented by: Intertek
3:45 - 4:15 pm	When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved	Multiple federal government agencies work together to combat securities and healthcare fraud in the medical products space, including SEC, FDA, and DOJ. Navigating enforcement interactions with these agencies is exceedingly complicated. Duane Morris LLP will provide an update on recent areas of focus for the agencies involved in investigating securities and healthcare fraud and will discuss: Best Practices for Avoiding Enforcement Actions What to Do Before the Government Calls When You Suspect You May Have a Problem Responding When the Government Does Call Presented by: Duane Morris

SPEAKERS

	Troy Tazbaz Director of Digital Health Center of Excellence (DHCoE) Center for Devices and Radiological Health (CDRH) FDA Troy Tazbaz is Director of Digital Health Center of Excellence (DHCoE) at FDA. DHCoE within the Center for Devices and Radiological Health (CDRH) is responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. Troy Tazbaz is responsible for providing leadership in technology evaluation and integration into clinical care, policy development to establish digital health guidelines, and strategic public-private institution partnerships. Prior to joining FDA, Mr. Tazbaz was at Oracle for 11 years, holding a variety of technical and business responsibilities in building and scaling the cloud business as Senior Vice President of Industry Business Unit Strategy & Operations.
	Darshak Sanghavi, M.D. Program Manager ARPA-H Dr. Darshak Sanghavi joined ARPA-H in May 2023 from Babylon – a digital-first, end-to-end healthcare provider serving more than 24 million people across the globe. As chief medical officer, he was responsible for overseeing the company’s international operations as well as leading its wider mission to help bring affordable and accessible healthcare to everyone worldwide. Previously, Sanghavi worked as national chief medical officer for UnitedHealthcare and OptumLabs, as a group director at the Centers for Medicare & Medicaid Services Innovation Center during the Obama Administration, as managing director of the Engelberg Center for Health Care Reform at the Brookings Institute, and as a pediatrician for the U.S. Indian Health Service. He has a doctorate in medicine from Johns Hopkins University and specializes in pediatric cardiology after training at Boston Children’s Hospital. Sanghavi is a best-selling author and a regular contributor to the New York Times, Boston Globe, and Washington Post.
	Rajesh Misra Principal KPMG Rajesh is a principal with KPMG and leads the Life Sciences Quality and Regulatory practice in the US. He works with the Life Sciences organizations in solving their most pressing quality, regulatory and operational challenges across the entire value chain. Rajesh advises organizations in current good manufacturing practices (“cGMPs”) and quality systems, regulatory pathways, commercialization, and post-market surveillance. He is passionate about leveraging emerging and disruptive technologies to address Quality and Regulatory challenges within the Life Sciences industry.
	Amra Racic, MBA Senior Director, Government Strategy, MedTech Veeva Systems As Senior Director of Government Affairs, MedTech 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.
	Nicholas Abbondante Chief EMC Engineer Intertek Nicholas has served as Intertek’s Chief EMC Engineer since 2013, responsible for technical support of Intertek’s global network of 24 EMC labs. In his 22+ years with the company, he has been involved in testing a wide range of radio and electronic equipment to EMC requirements for regulatory domains around the world, specializing in transmitters and medical devices. He is the Technical Manager of Intertek’s TCB program and is TCB Council Board Vice Chair, and serves as the CISPR/A Secretariat. An active participant in many ANSC C63 standards projects, he is chair of both C63.31 for ISM device measurement and C63.25.3 for 18-40 GHz test site validation, and was recently elected as the incoming chair of Subcommittee 4 for wireless and ISM equipment measurements. He is also a working group member of C63.10 and C63.26 for radio testing, C63.4 Emissions, C63.16 ESD, C63.33 EAS immunity and the recently completed C63.2 Receiver, C63.29 Lighting and C63.30 Wireless Power Transfer standards. Nick has a Bachelor’s degree in physics from the Worcester Polytechnic Institute (WPI) in Massachusetts, USA.
	Frederick (Rick) R. Ball Partner Duane Morris Frederick 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.
	Brian Blonowicz Senior Manager, Regulatory Software and Interoperability Center of Excellence Beckton Dickinson (BD) Brian and his team lead software and interoperability teams through regulatory submission projects including strategy and execution to continuously improve submission quality and efficiency. Prior to joining BD, Brian was an independent consultant leading many teams to successful submissions and regulatory correspondence in the areas of software, interoperability, verification and cybersecurity for a variety of devices and software products.
	Pamela F. Forrest Partner Covington Pamela Forrest has over 25 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements.
	Liz Haines Vice President, Global Regulatory Affairs TransMedics, Inc. Liz is responsible for leading the company’s global regulatory affairs team in achieving market access and availability of products for patients suffering from end-stage organ failure . Liz has 20 years of experience in Regulatory Affairs and Quality supporting Medical Device and Life Sciences companies by delivering effective strategies to ensure safe products, strategic market entry and compliance. Liz earned a Bachelor of Science in health management at Northeastern University, several executive certificates in strategy and leadership at Cornell University and has Six Sigma Yellow Belt and Lean Leader designations. Liz also is a part-time lecturer at Northeastern University teaching students around Medical Devices related to Regulatory Affairs.
	Coleen Hill Attorney 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.
	Christina Kuhn Special Counsel Covington Christina Kuhn advises medical device, life sciences and digital health companies on a broad range of FDA regulatory strategy and medical device compliance matters. She frequently helps clients successfully navigate the premarket medical device regulatory process, advising companies on regulatory classification, product development and clinical strategy, and agency interactions. Ms. Kuhn also has significant experience counseling medical device companies on postmarket compliance requirements.
	Benny Lam, PhD Director of Regulatory Software Strategy Philips Benny Lam is Director of Regulatory Software Strategy in Philips’ Innovation & Strategy organization overseeing a number of complex regulatory strategy and submission projects. He is leading several initiatives on AI-enabled medical device and software platform regulatory framework development with the objective to improve end-to-end operational excellence of Philips’ regulatory organization and its stakeholders for commercial success. Prior to joining Philips, Benny was with US FDA Center for Devices and Radiological Health (CDRH), firstly as a Lead Reviewer in Division of Radiological Health (now OHT8), then Digital Health Policy Staff, leading numerous pre-market and post-market submission reviews as well as development of regulations, guidance documents, and policies.
	Mira Leiwant Vice President, Regulatory Affairs, Quality and Clinical Affairs Anika Therapeutics, Inc. Mira Leiwant currently serves as VP of Regulatory Affairs, Quality and Clinical Affairs for Anika Therapeutics and its subsidiaries Parcus Medical and Arthrosurface. Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. Her responsibilities include strategic regulatory compliance planning and assessment for all Anika’s products, developing quality systems to meet ever-changing global regulatory demands, and conducting clinical research to support regulatory and commercial demands. She has over 20 years’ experience in the medical device industry, with varying roles from R&D to Quality Assurance and Regulatory Affairs, for products in the therapeutic areas of cardiology, wound care, regenerative medicine, and oncology. She earned both Bachelor’s and Master’s degrees in Mechanical Engineering from Cornell University and holds a Regulatory Affairs Certification (RAC).
	Kevin Rowland Director of R&D RQM+ Kevin Rowland, M.S. received his bachelor’s degree in ceramic engineering in 2001 followed by a master’s degree in 2003 in materials science and engineering, both from Alfred University. He then received a master’s degree in chemistry from Brown University under Dr. Brian Moulton in 2008 with research focusing on molecular self-assembly. Kevin has been at Jordi Labs (now part of RQM+) for 13 years and has served as team leader for the GCMS and LCMS groups as well as Laboratory Manager. His work has focused on interpretation of high-resolution accurate mass MS data for identification of non-target, unknown compounds. He is currently serving as Director of Research and Development, focused on development of advanced methods for characterization of extractables and leachables.
	Peter Shearstone Vice President, Global Quality Assurance & Regulatory Affairs Thermo Fisher Scientific Peter Shearstone joined Thermo Fisher Scientific in 2018 as Vice President, Global Quality Assurance and Regulatory Affairs (QARA), and is responsible for leading the company’s global, corporate QARA team to ensure our products are safe and comply with their intended use. Headquartered in Waltham, Massachusetts, Thermo Fisher is the world leader in serving science; our mission is to enable our customers to make the world healthier, cleaner and safer. Prior to joining Thermo Fisher, Peter worked in executive-level quality and regulatory roles for 30 years, most recently at Sysmex America, where he served as Vice President, RA/QA/Clinical and Medical Affairs. Prior to that, he held QA leadership roles at Abbott Diagnostics and Siemens Healthcare. Peter holds a bachelor's degree in biology from Salem State University in Salem, Massachusetts.
	Darcy Sheerin Quality Management Senior Solutions Consultant Dassault Systemes Darcy works for Dassault Systemes helping companies advance their Digital Transformation journey (from discovery/research through manufacturing/supply chain). With more than 30 years' experience in life sciences, Darcy has experience managing and executing all phases of medical device development from clinical studies to end of life. Darcy has been involved in early phase start-up companies from conception, market need and definition, product design, production and First in Man clinical research. Prior to working in the medical device industry, Darcy worked full time in the Cardiac Cath Lab, where she gained valuable hands-on experience in adult and pediatric interventional cardiology, as well as neuro and peripheral vascular interventional experience.
	George Strom Business Development Director of IOT Intertek 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.