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Regulatory Roundup

Wednesday, November 13, 2024 (8:00 AM - 4:30 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. The agenda includes comprehensive presentations by FDA officials, industry representatives and regulatory experts.

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

AGENDA

View the final agenda here, which includes the following confirmed topics:

Keynote presentation from Dr. Michelle Tarver, Director, CDRH, FDA
Moderated Q&A session with Dr. Michelle Tarver, facilitated by Veeva Medtech
Stories From the Front Lines industry panel, a moderated discussion of "what keeps them up at night" including Medtronic, Gentuity, Podimetrics and Haylex Orthopedics
FDA’s New Quality Management System Regulation (QMSR) – What’s New and How to Get Ready for the Feb 2026 Implementation Deadline presented by Arena
Driving Value with the Adoption of AI in Healthcare QARA Systems, an interactive conversation with IQVIA Technologies and Foley Hoag LLP
Which MedTech Companies Will Survive the Coming PCCP Shakeout?, presented by Ketryx
Laboratory Developed Tests (LDT) and In Vitro Diagnostics as Regulated Medical Devices, presented by Ropes & Gray
Accelerating Regulatory Approvals & Time to Market with AI-powered Clinical Data and Virtual Twins, presented by Dassault Systèmes
Insights Into The Development Of IEC 60601-1 4th Edition, presented by Intertek

SPEAKERS

	Michelle Tarver, MD, PhD Director Center for Devices and Radiological Health (CDRH) Food and Drug Administration Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Center Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture. Dr. Tarver has held various leadership positions while at the FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation, and the Program Director of Patient Science and Engagement. Read more.
	Amra Racic, MBA Vice President, Government Strategy, MedTech Veeva Systems As Vice President of Government Strategy, 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.
	Marie Buharin Regulatory Affairs Director Medtronic Marie Buharin serves as Regulatory Affairs Director at Medtronic Diabetes, where she leads regulatory strategy and execution across a diverse product portfolio. Marie has specialized expertise in areas such as digital health, Software as a Medical Device (SaMD) and connected devices. Her career spans leadership roles across organizations ranging from startups to Fortune 500 companies, where she has consistently fostered a collaborative and transparent approach to regulatory compliance. Marie’s ability to build strong partnerships with regulators and cross-functional teams drives alignment and innovation across regulatory processes, ensuring successful outcomes for the business and patients alike.
	Chris Cain Vice President, Clinical & Regulatory Affairs Hyalex Orthopaedics Chris Cain has over 25 years of experience designing, conducting and summarizing clinical research trials, and developing and implementing regulatory strategies for Class 2 and 3 medical devices. He currently serves as Vice President, Clinical & Regulatory Affairs at Hyalex Orthopaedics. In his role at Hyalex, he has global responsibility for all aspects of clinical research and regulatory affairs for the HYALEX Cartilage System. Prior to joining Hyalex, Chris was VP of Clinical and Regulatory Affairs for Devoro Medical (acquired by Boston Scientific), Conformal Medical and Corindus Vascular Robotics (acquired by Siemens). In his previous roles, he was responsible for global clinical activities supporting regulatory marketing clearances and approvals, and clinical evidence generation contributing to the companies’ publication portfolios. He also led global regulatory strategy resulting in marketing authorizations worldwide. He earned a B.S. of Nursing form the University of Central Missouri and an MBA from University of Missouri Kansas City.
	Alexis Compton Medical Device Quality Engineer Allotex Alexis Compton is a dedicated and results-driven Quality Engineer with a background in biomedical engineering and diverse experience in the medical device industry. She has worked in production, R&D, and QA. Currently at Allotex Inc., Alexis plays a key role in optimizing product quality, ensuring regulatory compliance, and driving continuous improvement initiatives across the organization. Since joining Allotex in August 2023, Alexis has led the implementation of a new Quality Management System (QMS) in Arena PLM by taking charge of data transfer, system integration, and employee training. In this capacity, Alexis became the company's change administrator, guiding the organization through the transition and educating staff on the system’s use to enhance operational efficiency. In addition to this, Alexis contributed to the design and development process for an FDA IDE submission, where she provided critical input into use, process, and design FMEAs and also compiled a Design History File Index.
	Chris Escobedo Hart Partner Co-Chair, Privacy & Data Security Practice Foley Hoag LLP Chris Hart is an experienced civil litigator and human rights lawyer with a focus on cybersecurity and global data protection. As co-chair of Foley Hoag’s Privacy and Data Security practice, Chris counsels clients—ranging from startups to Fortune 500 companies—on data privacy and cybersecurity compliance, incident response, government investigations, and litigation stemming from an organization’s data management and governance practices. As a civil litigator, Chris has successfully represented clients in products liability, complex tort, and class action matters.
	Erez Kaminski Founder & CEO Ketryx Erez Kaminski is the Founder and CEO of Ketryx, the life sciences industry's first and only connected application lifecycle management software designed to improve quality and release software faster. Erez founded Ketryx after working at Amgen as the head of AI/ML for their medical device division. Prior to Amgen, he served as the special assistant to the CEO of Wolfram Research, the builders of Mathematica and Wolfram\|Alpha, and as a visiting researcher at Princeton Plasma Physics Labs. Erez holds a Master of Science in Electrical Engineering and Computer Science and a Master of Business Administration from the Massachusetts Institute of Technology.
	Michael King Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect) Digital Products & Solutions IQVIA Technologies As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible for ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimizing business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions. Before joining IQVIA Michael was the Vice President of International Regulatory Affairs for a Dental Technology organization and had oversight of the International Product Registration, Adverse Event Reporting and country-based Quality Management Systems.
	Todd Konieczny Quality Supervisor, Technical Laboratory Manager Intertek Boxborough In more than 25 years with Intertek, Todd has guided medical device manufacturers through the complex regulatory process. He has expertise in the 60601, 60825, 61010 and 80601 series of standards. He is a participant in numerous AAMI and IEC Technical Committees, and a member of NEC CMP Panel 12.
	Greg Levine Partner, Life Sciences Regulatory & Compliance Group Ropes & Gray Greg focuses his practice on FDA regulation of pharmaceuticals, biotechnology and medical devices. He provides advice, counsel, and representation before the FDA to leading pharmaceutical and medical device companies on their highest stakes matters and represents clients before state and federal regulators on all phases of the product lifecycle. Greg also advises manufacturers of other FDA-regulated products, including cosmetics and dietary supplements, on a broad range of issues under the Food, Drug, and Cosmetic Act and related laws and regularly assists FDA-regulated clients with both internal and government compliance investigations and enforcement actions. In addition, Greg has litigated against FDA in Administrative Procedure Act matters, including in high profile cases such as Bracco v. Shalala that have become important APA precedents.
	John McCarthy Life Sciences & Healthcare Industry, Business Consulting Dassault Systèmes John leads a global team of Business Consultants in the Life Sciences & Healthcare Industry at Dassault Systèmes. For twenty years, John has served MedTech companies from initial idea creation through planning, development and market delivery. He understands the hypercompetitive pressures manufacturers face and the intense race to get to market first with personalized and affordable devices that meet the rigor of regulatory requirements for quality and patient safety while meeting the high expectations of clinicians as well. John brings together the MedTech industry of clinicians, researchers and regulators and champions the use of advanced technologies that will help organizations accelerate innovation and safely lower the barriers to regulatory approval.
	Yaqing Liu Global Chief Engineer, Medical Intertek Yaqing Liu is the Global Chief Engineer for Intertek’s Medical Devices business. She is a member of multiple IEC standard committees and an IECEE CB scheme and A2LA assessor. A native of China, she has been working with medical device manufacturers to help them understand and meet regulatory requirements for more than 15 years.
	Wayne “Aaron” Snyder Vice President Quality Assurance Allotex Aaron Snyder is a QMS foresight leader, learner, trainer, consultant, and innovator. He is a recognize authority in leading QA teams to implementing QA processes to withstand regulatory review. His focus is on simplicity, efficiency, and compliance to facilate business performance. He is an expert in understanding of FDAs current good manufacturing practices (both medical device & pharmaceutical).
	Sharon Timberlake, MSHS, RAC, CCRA Vice-President of Clinical, Quality & Regulatory Affairs Gentuity, LLC Sharon is the Vice-President of Clinical, Quality & Regulatory Affairs for Gentuity, LLC, where she focuses her energies providing leadership on regulatory affairs, clinical affairs and quality assurance as well as new product development and manufacturing as she works with the management team to define the strategic direction of the company and drive business growth. She has practiced exclusively in the areas of Clinical, Quality, and Regulatory Affairs for medical device companies for over 25 years. Ms. Timberlake received her MS in Health Sciences, Clinical Leadership from George Washington University of Medicine and Health Sciences and is certified in both Regulatory and Clinical Research. Ms. Timberlake has been elected as an FDA industry representative serving multiple 4 year terms over the last 15 years. She is currently serving on the Obstetrics and Gynecology Devices Panel.
	Beth Weinman Member, Life Sciences Regulatory & Compliance Group Ropes & Gray Beth focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices, cosmetics and dietary supplements. As a former lawyer with the U.S. Food and Drug Administration, Beth brings valuable perspective to clients who turn to her for representation in government investigations, assistance with internal compliance investigations, FDA enforcement actions, product recalls and other agency engagement strategies. Clients frequently look to Beth for representation when facing government investigations or engaging with FDA on regulatory compliance matters, particularly in connection with alleged manufacturing practice violations or inappropriate marketing. She has extensive experience representing clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, internal compliance investigations, and other enforcement actions before state and federal regulators. Beth also represents clients in administrative litigation and assists in assessing risk in transactional matters.