Preconference Workshop: AI Across Pharma and Devices: Navigating Innovation, Risk, and Compliance as Regulatory Professionals

Description: Artificial Intelligence (AI) is rapidly transforming the landscape of medical product development, presenting both significant opportunities and complex challenges for regulatory professionals. As AI becomes integral to drug and device development, regulatory professionals have a pivotal role to play—not only in ensuring compliance and patient safety but also in shaping the governance frameworks that define AI’s future in a highly regulated space. This session will provide actionable insights into how regulatory professionals can strategically position themselves as key contributors to AI governance discussions, regardless of where AI is applied in the medical product lifecycle.

The session will explore approaches to navigating evolving AI policies, from data harmonization and algorithm transparency to compliance with global regulatory frameworks. Attendees will gain practical strategies for leveraging regulatory intelligence to anticipate emerging AI trends and align organizational goals with regulatory requirements. The importance of effective communication strategies for engaging with stakeholders—including health authorities, developers, and cross-functional teams—will also be discussed, with a focus on building trust and demonstrating regulatory excellence.

In addition, the session will address AI-specific crisis management, offering guidance on identifying, mitigating, and responding to risks such as data bias and algorithm failures. Insights into how regulatory professionals can proactively contribute to AI governance policies—ensuring ethical, transparent, and patient-centric deployment of AI technologies—will be a central focus.

By the end of the session, attendees will be equipped with the knowledge and frameworks needed to secure their seat at the table in AI governance discussions. This will empower them to lead efforts that balance innovation, compliance, and global regulatory expectations, ensuring AI technologies drive meaningful and sustainable advancements in healthcare.

7:30 – 8:30 AM: Breakfast for Preconference Workshop Attendees

8:00 – 8:30 AM: Welcome and Workshop Introduction

Session I: Foundations & Intuition for AI

8:30 – 8:40 AM: Kickoff Survey & Workshop Wishlist
- Comfort level, use cases, benefits & concerns
- Participant Focus Areas

8:40 – 9:40 AM: Demystifying AI – Black box to Glass box

Q&A

9:40 – 10:30 AM: Developing an Intuition for AI (Interactive)

Interactive exercise: 10 real-world scenarios → assess AI fit

Audience sharing of real-world AI examples

10:30 – 11:00 AM: Refreshment Break

Session II: AI in Medical Devices

11:00 – 11:30 PM: Global Regulatory Overview for AI in Devices

Interactive case-matching activity: teams classify example AI device use cases (FDA class, MDR class, AI Act risk level)

11:30- 12:00 PM: Requirements & Risk Management for AI/ML in Medical Devices

Risk & Mitigation Workshop: groups review an AI diagnostic tool, identify risks (bias, drift, safety) & propose mitigations; map back to FDA/EU frameworks

12:00 - 12:30 PM Practical Implementation and Future Trends

12:30 – 1:30 PM: Lunch

Session III: AI in Pharma

1:30 – 2:30 PM: Cross-Phase Perspectives

Interactive Exercises

2:30 – 3:00 PM: Contrasting AI Application in Devices & Drugs

3:00 – 3:15 PM: Afternoon Break

Session IV: Risk Calculus, Governance, Stakeholder & Crisis Management

3:15 – 4:15 PM: Evolving role of Regulatory professionals

4:15 – 4:30 PM: Wrap-Up & Key Takeaways

Balancing innovation with regulatory rigor

Resources

Open Q&A