Sponsored Webcast: Transforming Regulatory Compliance with Artificial Intelligence

When:  May 14, 2024 from 11:00 to 12:00 (ET)


We will have 4 panelists discussing AI in Regulatory and how artificial intelligence is impacting regulatory compliance for medical devices. We will discuss how AI can help streamline the process, track changes, improve reporting and so much more. With the growing complexity in the regulatory space, we will discuss why it is important for regulatory teams to adapt and stay ahead of these changes.

Registration Fees & Deadlines

Free

Learning Objectives

  • Explain the growing complexity of the regulatory space

  • Show the role of AI and automation in regulatory compliance (streamlining submissions, tracking regulatory changes, collaborating with distributors, ensuring team alignment, and tracking KPI's)

  • Share what you can do to ensure your products get to market faster and remain compliant.

  • Things to think about when considering an AI solution or RIMS (Regulatory Information Management System)

Who Should Attend?

  • Regulatory Affairs Specialists VP of Regulatory Sr.VP Regulatory VP, Global Regulatory Affairs Sr. VP of Regulatory Affairs

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

Priya Paul
Founder & CEO, RegDesk.co

RegDesk is an AI-powered RIM platform for medical device companies. It allows regulatory
affairs teams to prepare, manage, and publish international submissions within days compared
to months.

Priya has over 15 years of experience in the medical device industry. Prior to starting RegDesk,
Priya spent 5 years as a global regulatory consultant, where she helped numerous device
companies launch products globally. Prior to being a consultant, she was the Director of New
Business Development for a healthcare technology company. She started her professional
career as a Product Design Engineer at Baxter Healthcare.

RegDesk is currently a leading RIM platform for many of the top MedTech companies. It was one
of the 7 companies selected out of hundreds to partake in the Digital Health Accelerator in
Philadelphia. It was also selected for the elite DreamIt Health Program. RegDesk was the winner
of Startup Health in 2014.

Priya holds an M.S. in Quality Assurance and Regulatory Sciences from Northwestern University,
where she won a Distinguished Thesis Award. She also holds an M.S. in Biomedical Engineering
from the University of Illinois with Honors and a B.S. in Biomedical Engineering from the
University of Illinois, Urbana-Champaign.

Elizabeth (Liz) Haines
Professor, Northeastern University

Donald Ellis
Vice President, Global Regulatory Affairs at Reva Medical

Ann Vu
Senior Vice President Quality, Regulatory and Clinical, ZimVie, Inc

Ann is currently Sr.VP quality, regulatory & clinical at ZimVie, Inc. She brings more than 25 years
of quality and regulatory experience in the medical device, pharmaceutical, nutritional, and
biologics sectors. Ann joined ZimVie from Zimmer Biomet, where she led Global Quality
Systems, as well as Regulatory Affairs for Robotics and several other business units. She has also
held progressive leadership roles with global companies, including Ethicon, Ortho Clinical
Diagnostics, Bausch + Lomb, and Steris. Ann is also a volunteer attorney with Elder Law &
Advocacy in San Diego, California.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org