LIVE DECEMBER 13th & 15th

Then Available on Demand

3 Use Cases for Digital Regulatory Information

MedTech’s global regulatory landscape has evolved, and more programs are being introduced to support further innovation. Join us for a tour of enabling a digital regulatory landscape in your organization to learn:

  • The imperatives of enabling a digital regulatory function within your organization
  • An approach of how to do it from a process perspective
  • How to leverage the latest technology to achieve regulatory intelligence
Share On X
Share On Linkedin
Share Via Email

Register

Webinar Series Overview

See Session Details for December 13th
See Session Details for December 15th

What to Expect

  • USE CASE approach to talk about driving forces behind the “digitization” of regulatory information
  • Learn from speakers about insights and strategies to implement a digital organization with regulatory and product development tied together, including real-world experiences and examples
  • Discover a SOLUTION approach to manage product information that is regulatory savvy and traceable for managing change impacts
  • Learn how to stay ahead of evolving regulatory changes and prepare the process and systems to react to new regulations quickly and smartly
Register Now

Key Takeaways

  • Visibility of product changes early in the product lifecycle to regulatory affairs
  • Enablement of digital thread with regulatory and quality
  • Manage UDI requirements for multiple countries
  • Overcome siloed distribution and issues due to infrequent communication between submission approval and inventory
  • Accurate reporting and data science

Featured Speakers

Sajesh Murali
Director, Life Sciences

ArcherGrey

Sajesh is the Director of Lifesciences at ArcherGrey. As a mechanical engineer with over 20 years of experience in Product Lifecycle Management(PLM) and 10+ years of medical device experience in Quality and Regulatory, he assists medical device clients with large-scale transformational PLM programs focusing on new product development, design controls, regulatory, and change management.

Caroline Byrd
VP of Regulatory, Quality, and Clinical

Nextern Innovation

Caroline is a mechanical engineer with over 20 years of medical device experience in Quality, Regulatory, R&D, and Operations.

In her role at Nextern, she is part of the executive team enabling the realization of medical device innovations with collaborators, at every stage of a device’s lifecycle, for any part of the world where patients are in need.

 

Patrick Sullivan
Vice President

ArcherGrey

Business Executive focused on enabling the digital thread by leveraging PLM technology and processes for leading brands to reach maximum ROI and efficiency.

Session Details

Session 1: December 13th at 12PM CST

Use case 1 – As Regulatory Affairs, I want to be able to maintain control of my product registration planning and related scope alongside the product development process.

Executive Summary
  • Change management and reporting
  • Where are your products registered
  • New product release planning from a regulatory perspective
  • Manual data entry to manage regulatory information
Register Now
Session 2: December 15th at 12PM CST

Use case 2 – As Regulatory Affairs, I want to efficiently control, relate and package product documentation for submissions.

Executive Summary
  • Related design history file
  • Minimize data duplication
  • Simplified user experience enabling better correspondence in audits

Use case 3 – As Regulatory Affairs, I want to efficiently communicate with distribution and track registrations.

Executive Summary
  • Integrated efficiency gain with distribution
  • Plan for expiring registrations
Register Now