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):
SPEAKERS
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.
Mike BrousseauRegional Chief Engineer, MedicalIntertek
In nearly 30 years with Intertek Mike has worked with electrical manufacturers across a wide range of industries – including medical, IT, industrial, lighting, and more – to meet regulatory, industry, and market requirements around the world.
Erez Kaminski Founder & CEOKetryx
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 McCarthyLife Sciences & Healthcare Industry, Business ConsultingDassault 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 LiuGlobal Chief Engineer, MedicalIntertek
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.
SPONSORS
PARTNERS
$225 for members
$275 for non-members
Early bird discount of $50 off through September 20th
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