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
Recent Developments on the 510(k) Front: A Deep Dive into FDA’s Recently Issued Draft Guidance on Predicate Device Selection
The Center for Devices and Radiological Health (CDRH) recently issued three draft guidance documents aimed at modernizing the 510(k) program, one of which proposes a significant shift in the process for identifying predicate devices for a substantial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will explore the potential legal, regulatory, and practical implications of the recommendations set forth in the draft guidance, including its potential impact on companies that will be submitting 510(k)s for new devices or for modifications to previously cleared devices.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
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.
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.
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
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.
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:
SPEAKERS
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.
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.
Benny Lam, PhDDirector of Regulatory Software StrategyPhilips
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 LeiwantVice President, Regulatory Affairs, Quality and Clinical AffairsAnika 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 RowlandDirector of R&DRQM+
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 ShearstoneVice President, Global Quality Assurance & Regulatory AffairsThermo 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.
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