Overview

The pharmaceutical industry is undergoing a transformative shift with the integration of artificial intelligence (AI) and machine learning (ML) into regulatory processes, exemplified by the FDA’s Enterprise Large-Language Model for Scientific Applications (ELSA). This 4-hour live webinar, led by Dr. Ajaz S. Hussain, a globally recognized leader in pharmaceutical quality, equips professionals with the knowledge and tools to navigate this new regulatory landscape.

Why You Must Act Now

Regulatory science is entering a new era—one driven by artificial intelligence and machine learning. The FDA’s implementation of the Enterprise Large Language Model for Scientific Applications (ELSA) is a transformative step in regulatory review. By harnessing natural language processing and anomaly detection, ELSA scans submissions—including NDAs, ANDAs, and BLAs—with unprecedented speed and scrutiny. This signals a shift in expectations: no longer is compliance judged solely by documentation quality, but by data integrity, traceability, model transparency, and language credibility. In January 2025, the FDA issued its "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products," introducing a risk-based assessment framework. This places the onus on sponsors and manufacturers to ensure AI models used in development or regulatory support are trustworthy, explainable, and built on high-quality, auditable data.
This trend is global. The UK’s MHRA has endorsed the Pro-Innovation Approach to Regulating AI and is already integrating its recommendations. Meanwhile, the Saudi Food and Drug Authority (SFDA) has launched the SAIL AI Lab, a dedicated hub for advancing regulatory science through the use of artificial intelligence.
At the same time, Industry 4.0 technologies—from smart factories to digital twins—are revolutionizing the pharmaceutical manufacturing industry. These changes require new professional capabilities, including data integrity stewardship, prompt engineering, and AI literacy.
Failing to adapt not only risks regulatory actions such as Complete Response Letters (CRLs) or FDA Warning Letters but also undermines market credibility, investor confidence, and, most critically, patient trust. The time to act is now. Regulatory agility, technical preparedness, and the ethical deployment of AI will determine who thrives in this new era—and who falls behind.

What You will learn

This webinar is organized into four focused sessions, each offering practical tools and insights tailored for R&D scientists, regulatory professionals, quality and compliance leaders, and digital transformation teams. While the sessions draw on the U.S. FDA as a primary example, the principles and practices discussed reflect the foundations of sound regulatory science applicable globally.

Key Outcomes

• Regulatory Compliance: Prepared for ELSA aligned with the FDA’s 2025 AI guidance with professional oversight & explainability
• Operational Efficiency: Implement appropriate professional-in-the-loop approaches for AI-driven processes to enhance assurance of quality and reduce development costs and review times.
• Professional Development: Gain skills like integrating question-based review with prompt engineering and AI stewardship.
• Strategic Planning: Develop a 90-day action plan for AI integration

Reserve Your Seat

Secure your seat today and gain the edge Dr. Hussain used to shape FDA standards—spaces are limited! Don’t miss this opportunity to future-proof your career and organization in the era of AI-driven regulation.
Future-proof your career and your organization—master the new currency of FDA oversight

Contacts

Technical Query: Ms. Tavleen Thakur, M: 7696125050, Email: t.thakur@glostem.com

Participation Query: Ms. Swati Kanwar, M: 8289015050, Email: s.kanwar@glostem.com

                                 Ms. Farheen Zainab, M: 7696225050, Email: f.zainab@glostem.com