Webinar · July 16, 2026 · 11:00am ET

Governing Safety in the RTCT Era: From AI Flag to Defensible Decision

A working session for sponsor safety and clinical-development teams on what the FDA’s Real-Time Clinical Trials initiative and AI-driven pharmacovigilance actually demand — and how to make physician judgment fast, documented, and inspection-ready.

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Online (Zoom) · 45 minutes + live Q&A

Two shifts arrived at once: the FDA’s Real-Time Clinical Trials (RTCT) initiative and the spread of AI through pharmacovigilance. Together they compress every safety obligation a sponsor carries. In 45 minutes, Dr. Ashok Srivastava walks through the part that doesn’t compress — physician benefit-risk judgment — and how to operate it at signal speed.

What we’ll cover

  • Why legacy pharmacovigilance assumptions fail CAR-T, ADC, and radioligand programs
  • The five-step path from an AI flag to a signed, audit-ready decision
  • The inspection question every AI-assisted safety program must be able to answer
  • A practical readiness model — grading your program against Levels 1–4

Who should attend

Heads of safety and pharmacovigilance, clinical development leaders, and quality/regulatory teams at clinical-stage oncology sponsors deploying AI in safety.

Your host

A

Dr. Ashok Srivastava, MD

Board-certified oncologist and the named physician reviewer behind AyurDatta’s Integrated High-Acuity Safety Governance (IHASG) model. Contributing physician on the AUCATZYL® CAR-T BLA. Physician reviewer across 100+ oncology trials.