Modeling & AI in Generic Drug Development: Reg Insights & Future Trends

Artificial Intelligence (AI) is rapidly transforming drug development and regulatory processes across the pharmaceutical industry. This workshop explores cutting-edge applications of modeling and AI throughout the drug development lifecycle, with particular emphasis on complex generics. Through presentations, panel discussions, and interactive sessions, attendees will examine how AI is being integrated into regulatory frameworks to streamline workflows, accelerate development timelines, and advance quantitative medicine approaches.

Key areas of focus include:

• Regulatory Perspectives: Current thinking from FDA, EMA, and other global regulatory bodies on AI integration in drug development and assessment processes
• AI-Driven Workflow Optimization: How AI enhances efficiency in regulatory writing, product development, and modeling workflows
• AI in Drug Development: Exploration of AI’s role in transforming drug development processes, including predictive modeling for drug substance development, formulation optimization, and process optimization
• AI and Quantitative Medicine: Discussion on how AI/ML approaches are extending quantitative medicine approaches, from pharmacometrics and systems pharmacology to translational modeling and digital twins

Join us for an immersive two-day experience featuring presentations from leading experts in regulatory agencies, pharmaceutical industry, and academia. All attendees will benefit from insights shared by a diverse group of speakers, including FDA officials, international regulatory experts, industry leaders, and renowned academics. This workshop offers a unique opportunity to:

• Understand the latest regulatory thinking on AI integration in drug development
• Learn about cutting-edge AI applications in the pharmaceutical industry
• Network with peers and experts in the field
• Gain practical insights into implementing AI solutions
• Explore the future of AI in drug development and regulatory science

Registration Fees:

• This workshop is FREE for virtual attendees.

• The combined cost for both days of in-person attendance and activities is:

• $350, in-person attendees – general
• $150, in-person attendees – government (must have an email ending in “.gov” in order to register at this rate)

For in-person attendees, beverages and food for breaks will be provided; lunch is not included. A link will be provided closer to the event for ordering lunch each day.

For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Other students, please email us for a reduced rate. Please contact us at (info@complexgenerics.org) and indicate which workshop you are interested in.