On demand
KP
How to Use AI in Drug Development Without Creating Compliance Risk
How to Use AI in Drug Development Without Creating Compliance Risk
KP
Hosted by
Jennifer Smith, PhD, Kevin Porter, MD
Executive Director · Pfizer
What we'll cover
- 0:00 Why AI Feels Risky
- 2:00 Map The Risk Surface
- 6:00 Safe Uses Worth Starting
Practical shifts you can apply this week
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Identify Risk By Task
Identify drug development tasks where AI creates low, medium, and high compliance risk.
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Evaluate Use Cases Against Requirements
Evaluate AI use cases against GxP, privacy, IP, and documentation requirements.
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Apply A Simple Decision Framework
Apply a simple decision framework for human review, validation, and traceability.
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Draft Practical Workflow Guardrails
Draft guardrails for prompts, outputs, and recordkeeping in regulated workflows.
Built by people who do the work
KP
Kevin Porter, MD
Global Medical Affairs Lead
What we'll cover
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0:00
Why AI Feels Risky
Why teams worry, where the real risk sits, and why use case matters more than magic-box thinking.
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2:00
Map The Risk Surface
Sort risk by data, decision type, and whether the output touches a regulated record.
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6:00
Safe Uses Worth Starting
Look at narrow, reversible use cases like summarization and formatting that are easy to verify.
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10:00
Red Flags And Failure Modes
See where risk jumps fast: fabricated citations, PHI exposure, version drift, and missing audit trails.
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14:00
Four-Step Use Decision
Use classify, constrain, review, document to make better calls without adding theater disguised as process.
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18:00
Team Rules And Close
Recap the framework, share plain-language rules, and finish with quick next steps and Q&A.
Questions people ask before registering
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It is for working professionals in drug development, quality, regulatory, clinical operations, medical writing, and related roles. If you touch regulated workflows and want practical AI guidance, you will be in the right room.
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No. The session is built for practitioners, not model builders. We focus on decisions, controls, and examples you can apply without writing code.
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Yes, a replay is typically shared with registered attendees after the session. You can review the framework again when you are not juggling fifteen tabs.
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It covers concrete examples from regulated workflows, including safe starting points and failure modes. You will see how the framework applies to actual decisions, not just abstract policy language.
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If a certificate of attendance or CE credit is available, it will be stated on the registration page or in follow-up materials. This session is designed first to be useful on Monday morning.
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The emphasis is on evaluating use cases and controls, not promoting a specific tool. That keeps the guidance more durable, since product names age faster than compliance headaches.