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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

Confirmed topics on the agenda include the following (to be updated):

Keynote presentation from Dr. Michelle Tarver, Acting Director, CDRH, FDA
Moderated Q&A session with Dr. Michelle Tarver, facilitated by Veeva Medtech
Driving Value with the Adoption of AI in Healthcare QARA Systems, presented by IQVIA Technologies
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

SPEAKERS

	Michelle Tarver, MD, PhD Acting 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 Acting 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.
	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.
	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.