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

Live Webinar

  • 90 minutes
  • 43 Days Left
     May 13, 2020
  •   01:00 PM - 02:30 PM ET
    10:00 AM - 11:30 AM PT

In April, the US Food & Drug Administration (FDA) published a request for comments on new proposals for the regulation of medical devices that employ artificial intelligence (AI) and machine learning (ML) components. This continues a trend over recent years of the FDA recognizing that regulation of software as medical devices (SaMD) must be different to how regulation has applied in the past. We believe the FDA’s AI/ML regulation proposals are an excellent start, uniting well-established risk management principles and best-practice guidance while also recognizing the challenges and opportunities developing and managing complex AI/ML products. The FDA has also coherently integrated existing SaMD regulatory principles into their new proposals. More broadly, the FDA’s proposals encapsulate many established industry and academic best practices in AI/ML implementation and management – so will be familiar to anyone who has worked on such systems in other sectors.

Join this session by expert speaker, Angela Bazigos, this session will engage professionals looking to understand the regulatory challenges of software as a medical device (SaMD) with a special focus on AI/Machine Learning (ML). 

Session Highlights:

  • 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 the development of regulatory strategies 

  • Develop and execute regulatory strategies that meet real-world needs posed by AI and ML

Why You Should Attend:

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.

Who Should Attend:

  • 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

You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it at your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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