Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)

In this webinar speaker will Demonstrate knowledge of US and EU perspectives on current developments and challenges stemming from the development and implementation of AI/ML in development of regulatory strategies.

Angela Bazigos
Instructor:
Angela Bazigos
Date:
Friday, May 29, 2020
Time:
09:00 AM PDT | 12:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 503006

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
Price Detail Options
Overview:

This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.

Why should you Attend: This session will engage professionals looking to understand the regulatory challenges of software as a medical device (SaMD) with special focus on AI/Machine Learning (ML).

Areas Covered in the Session:

  • Describe actual and future AI applications that are changing patient treatment and healthcare delivery through the exploration of real-world examples (across different diagnostic/therapeutic and technology areas)
  • Demonstrate knowledge of US and EU perspectives on current developments and challenges stemming from the development and implementation of AI/ML in development of regulatory strategies
  • Develop and execute regulatory strategies that meet real-world needs posed by AI and ML

Who Will Benefit:
  • VP of IT
  • Director of IT
  • Quality Managers
  • Project Managers (for CSV / IT)
  • Validation Specialists
  • Database Administrators
  • System Administrators
  • Directors / Senior Directors of Discovery
  • Directors / Senior Directors of Development
  • Directors / Senior Directors of Commercialization
  • Document Managers
  • Training Managers
  • Regulators


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.


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