Purchase any webinar and get OFF
CODE:
Live Webinar
SIGNUP AND FLAT OFF ON WEBINAR.
Description
The US FDA 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 drug development policy statements indicate these technologies are viewed as a harbinger of progress, and the FDA expects to see the five basic elements of drug development:
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- FDA Post-Marketing Safety Monitoring
AI production software validation has some new requirements as well
The Agency plans to apply its 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 it applies to drug discovery and development.
Areas Covered
- Generative AI
- AIRIS example
- The Drug Discovery / Development Process - 5 Key Steps and AI
- The US FDA Commissioner's Comments
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- Post-market Safety Monitoring / Reporting
- Patient Focused Development
Why Should You Attend
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 the FDA specifically mentions AIRIS, their statements indicate their thinking in general on AI in drug discovery and development, as well as a willingness to work with their regulated industry partners in expanding the use of generative AI into all appropriate areas of pharmaceutical development, production, and post-market monitoring.
Who Should Attend
- Senior Management in Pharmaceuticals
- QA / RA
- AI Software Programming, Documentation, Testing Teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants
Speaker
John E. Lincoln is the Principal of J. E. Lincoln and Associates, a consulting company with over 41 years of experience in U.S. FDA-regulated industries, 27 of which as head of his own consulting company. John has worked with companies from start-ups to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation, FDA responses, new/changed product 510(k)s, process/product/equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He's held Manufacturing Engineering, QA, QAE, and Regulatory Affairs positions at the Director and VP (R&D) levels. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, including 5 chapters in the RAPs validation textbook, and conducted workshops and webinars worldwide on regulatory issues. John is a graduate of UCLA.