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Introduction
While we frequently encounter new artificial intelligence (AI) applications in the pharmaceutical industry, do we truly comprehend the essence of AI, the regulatory framework overseeing AI solutions, and the potential challenges hindering the widespread adoption of these solutions? As artificial intelligence revolutionizes the pharmaceutical industry, understanding the regulatory intricacies is paramount from a developer’s, as well as a user’s perspective. This comprehensive course is designed to empower professionals with the knowledge, tools, and strategies needed to navigate the evolving intersection of AI and pharmaceutical regulation.
Who Should Attend
This course is tailored for professionals engaged in the intersection of AI and pharmaceutical development and manufacturing, including Scientists, Developers, Managers, Supervisors, Directors, Management, and Senior Executives in the areas of:
- Drug Discovery and Development
- Drug/Software Device Manufacturing
- Regulatory Affairs
- Quality Control and Assurance
- Legal and Ethical Compliance
- Marketing
- Software Development
- Data Science and Bioinformatics
Whether you’re a seasoned regulatory professional or a technology expert entering the pharmaceutical space, this course offers a unique opportunity to stay at the forefront of AI regulation and its transformative impact on drug development.
Meet The Trainer
Dr. Stephanie Pasas-Farmer is a recognized bioanalytical expert in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody-drug conjugate technology. Relying on insights gained over a 20-year career focused on bioanalytical operations across global biopharmaceutical companies, contract research organizations and consulting, Stephanie founded Ariadne Software® in 2018 and led development of Red Thread®, guiding it from inception to production as an artificial intelligence (AI)-enabled solution for common challenges in bioanalytical data auditing and statistical analysis. Prior to Ariadne Software, Stephanie created BioData Solutions®, a scientific advisory firm whose aim is to help sponsors advance early-stage molecules into potential new drug candidates with bioanalysis support and regulatory compliance planning.
Before founding BioData Solutions, she led a team of scientists at a global bioanalytical laboratory focused on the support of large molecule and antibody drug conjugate programs using LBA, LC‐MS/MS, and cell-based assays. Earlier career roles included management responsibility for quality control functions of bioanalytical laboratory operations, in addition to business development and research scientist positions.
Stephanie earned her PhD and MSc degrees with honors in pharmaceutical chemistry from the University of Kansas. She received a BS degree in chemistry from St. Mary’s College of Notre Dame.
