Demo: Agentifying Post-Approval Change Management
Wajeed Abdul
Post-Approval Change Management remains one of the most complex and resource-intensive regulatory processes. This session demonstrates how agentic AI can automate planning, impact assessments, workflow orchestration, and execution across the PACS lifecycle. Attendees experience an end-to-end demonstration that illustrates how intelligent agents can augment regulatory teams, reduce manual effort, and accelerate decision-making.
Freyr ONE USA 2026 · 2:30 – 3:00 PM · Main stage
Post-approval change management consumes up to 80% of regulatory resources in large pharma.
Managing numerous global changes requires significant cross-functional teams and lengthy timelines.
Freya turns a raised change into an assessment pack, identifying impacted products and registrations.
Changes flow in from change control, and Freya suggests what's affected, with a rationale for every suggestion.
Freyr's AI agents automate multi-market change assessments and suggest filing strategies.
Agents combine product data, dossier information, health-authority regulations and historical precedents to support regulatory decisions.
Human-in-the-loop judgement remains essential to validate AI recommendations and handle exceptions.
Experts are brought in only where their input is needed, and they finalize decisions based on agent insights.
Assessments are consolidated into a defensible regulatory strategy across markets.
A single compiled view gives teams the global picture they need to plan and prioritize filings.
Effective integration relies on harmonizing diverse change control systems into a unified middle layer.
AI parses inconsistent vendor data formats, so data pipes can be built in real time without disrupting the existing IT landscape.