Indiana Chapter Webcast: Using AI for Regulatory Intelligence or as SaMD

1.5
RAC Credits
Chapter Events Chapter Events
Tuesday, 10 May 2022 (3:30 PM) - Tuesday, 10 May 2022 (5:00 PM) Eastern Time (US & Canada)

Recent trends are indicating the merger between tangible medical devices and intangible algorithms, software, and data science is become more entrenched. In the presentation we will take a view of the Digital Transformation of Medical Devices, IVDs, and Digital Therapeutics from the perspective of regulatory frameworks, and what medical manufacturers should know to stay abreast and ahead of these changes. We will also take a look at how software is changing medical devices/IVDs, and how regulators and manufacturers/developers are adapting to these changes.

In order to understand the AI/ML most current landscape, we will provide an overview recent approvals and case studies showcasing the digital transformation of medical practice using the recent FDA-published list of Artificial Intelligence enabled devices. We will discuss the frameworks in requirements for QMS, Design Controls, and regulatory approvals of these devices using latest news from FDA, and it’s Digital Health Center, Australia’s TGA, and European MDCG relating to MDR/IVDR.

Our entire industry has migrated our procedures, documents, and methods from paper-based to digitized formats. However, the analysis of agency enforcement documents such as 483s and GMP warning letters has remained a manual process using hard copies and a highlighter. This is no surprise, as experience is required to identify and categorize the information accurately. Redica Systems has developed an algorithm to evaluate and tag documents to facilitate expert analysis and replace the hard copy and highlighter process. Data scientists and industry quality experts worked together to train an AI system to parse, identify, categorize, and organize the key elements from enforcement documents, freeing up experts’ time for other focused activities. Informed by the AI algorithm, experts can develop insights and mitigate risks that the AI discovered buried in the data. 

In this presentation, we will demonstrate the accuracy of the AI with two case studies, one of which analyzes the nuanced differences between compliance gaps in compounding versus traditional manufacturing facilities and another use case that extracts data integrity signals directly from warning letters.


Learning Objectives

What you will learn:
  • An understanding of the current state of approvals and regulatory frameworks for digital medical devices and the nuance differences in implementation between key regulators
  • The key technical requirements of SaMDs and Software in Medical Devices
  • The differences in classifications for these devices and that impact of common claims and functions have on the applicable regulatory framework

Agenda

Jerry Chapman: Presentation #1: Enabling Quality and Regulatory Professionals with Structured Data and Actionable Insights Using AI

TJ Thiel and Luis Jimenez: Presentation #2: SaMD Regulatory Consideration Integrating AI/ML

This event is brought to you by RAPS Indiana Chapter to encourage knowledge sharing and community development. RAC holders may claim 2.0 RAC recertification credit.

A live Q&A portion with the speaker will follow the presentation.


Who Should Attend?

Pharma and medical device company quality, compliance, and regulatory personnel and management.


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.


How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation.


RAPS Membership

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


Featured Speaker:

Jerry Chapman

Jerry Chapman is senior GMP quality expert at Redica Systems. He brings more than 40 years’ experience in the pharmaceutical industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. He designed and implemented a comprehensive GMP intelligence process to identify, analyze and archive pertinent drug GMP regulations, inspection findings, trends and best practices. Chapman was founder and chairman of the GMP intelligence subgroup of the Midwest Discussion Group from 2005 to 2010.

He was senior editor at International Pharmaceutical Quality for six years; editor-in-chief for Xavier Health; has spoken at PDA, AAPS, ISPE and RAPS events; and has served as a consultant to the animal health and compounding pharmacy industries. At Redica Systems, Chapman works with the machine learning and data science teams building computer models that examine enforcement actions and other data to produce expert analyses. He also writes articles on current hot topics in pharma and international regulation for the Redica Systems Conference Spotlight page.

TJ Thiel

TJ Thiel, Senior Director, PharmaLex Australia

TJ Thiel is a Senior Director for PharmaLex Australia a division of PharmaLex, a global regulatory, quality and strategic advisory firm. He has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches.

Luis Jimenez

Luis Jimenez, Vice President of Business Development, PharmaLex

Luis Jimenez, serves as the Vice President of Business Development for PharmaLex. His experience includes operations, quality control in cGMP manufacturing, regulatory affairs for manufacturing, design engineering, technology transfer and project management within a start-up and large corporations such as Johnson & Johnson and Express Scripts. His trajectory in diverse health-related companies including building a class III medical device bio-tech company from the bottom-up provides him with hands-on experience solving the challenges of navigating regulatory approvals. Luis is passionate about the juncture between life sciences innovation, entrepreneurship, and regulatory frameworks.

Thank you to our Platinum Chapter Sponsors:




Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

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

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