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The use of Generitive AI in the Drug Discovery and Development Process. The US FDA’s encouragement of AI technology in pharma development and clinicals — their risk-based framework.
The U.S. Food and Drug Administration has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used on a limited but growing scale by industry to aid in screening for diseases and to provide treatment recommendations.
The recent FDA authorizations of medical devices and their drug development policy statements indicate these technologies are viewed as a harbinger of progress that the FDA expects to see across the five basic elements of drug development:
AI production software validation has some new requirements as well. The Agency plans to apply their current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these drugs.
This seminar will evaluate these stated FDA policy shifts as they apply to drug discovery and development.
Generative AI is a type of artificial intelligence (AI) that attempts to match or surpass human thinking abilities across a wide range of large data tasks. The FDA is adapting to the use of AI in medical products, and has recently issued policy statements on an advanced form of AI in pharma development, looking to the future. One of these is AIRIS. AIRIS operates without pre-set commands or training data, solving problems and creating rules as it navigates the virtual world. In artificial intelligence (AI), creating adaptable systems that learn independently is a key goal, and AIRIS (Autonomous Intelligent Reinforcement Inferred Symbolism) is an AI system designed to do just that. It is enabled to adapt and solve problems in new situations without needing explicit programming for each task. While FDA specifically mentions AIRIS, their statements indicate their thinking in general on AI in drug discovery and development, as well as a wiliness to work with their regulated industry partners in expanding use of generative AI into all appropriate areas of pharmaceutical development, production, and post market monitoring.
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Saint George, Utah
John E. Lincoln is a globally recognized FDA Compliance, Validation, and Quality Systems expert with over 40 years of experience supporting pharmaceutical, biotechnology, medical device, and FDA-regulated industries. He is the Founder and Principal Consultant of J.E. Lincoln and Associates and has successfully guided organizations worldwide through FDA inspections, remediation programs, CAPA improvements, software validation, 21 CFR Part 11 compliance, and risk-based quality systems implementation.
Known for his practical, real-world approach, John has trained thousands of industry professionals on FDA expectations, data integrity, CSV/CSA, GMP compliance, and inspection readiness. His extensive experience helping companies resolve complex regulatory challenges makes him a highly respected speaker and trusted industry advisor.
