RegulatorySession 1
Global Regulator Dialogue: Accelerating Access Without Compromising Safety
Regulators are finding ways to reduce the burden of getting your product into their market without compromising patient safety. Take this intel back as the foundation of your market access and regulatory strategy.
Martha Betz, Ph.D., FDA CDRH · Ashley Boam, FDA CDER · Stephen Maddocks, MHRA
Moderator: Marla Phillips, Pathway for Patient Health
How do top executives prove the value of quality?

Paul Foley
Gilead Sciences

Elaine Shannon
Takeda

Bala Sreenivasan
Merck
Executive leadershipSession 2
Executive Roundtable: The Executive Edge on Advancing Value
How senior executives measure "Proof of Value" and "Trust as an Outcome" while transforming operating models, and how you can use the economics of quality to mobilize your enterprise.
Paul Foley, Gilead Sciences · Elaine Shannon, Takeda · Bala Sreenivasan, Merck
Moderator: Peter Shearstone, J&J MedTech

Nidia Acevedo
Eli Lilly
Risk managementSession 3
One Risk Mindset: How to Achieve True Integration at Every Level
The "how" of aligning risk decisions across every level of your organization with your enterprise risk tolerance, so every employee is empowered to think like the CEO.
Nidia Acevedo, SVP Global Quality Compliance, Eli Lilly
Moderator: Ian Hooley, Zimmer Biomet

Nina Alli
Biohacking Village
CybersecuritySession 4
Cyber Breach: Take Action!
With criminal sophistication on the rise, learn the preventive measures and fast actions behind a cyber preparedness plan that protected patients, and that regulators and shareholders now expect.
Nina Alli, CEO and Executive Director, Biohacking Village
Moderator: Lacey Harbour, Pathway for Patient Health
Quality systemsSession 5
QMS of the Future: Maximizing Agility
How a future-ready QMS turns dependable quality into organizational speed, making Quality the spark that mobilizes the enterprise. Practical strategies you can put to work immediately.
Peter Shearstone, VP and Chief Quality Officer, J&J MedTech
Moderator: Marcelo Trevino, Illumina
When does AI need validating, and how much?

Charlene Cho
Microsoft AI

Teginder Singh
Google

Taha Jilani
Otsuka

Hari Subramanian
Otsuka
AI & data integritySession 6
Is Your AI Telling the Truth? Validation, Data Integrity and Control
AI is outpacing the standards meant to govern it. Standards gaps, a practical decision flow, how to validate, why AI's drive to be "right" can rewrite your data, and the management system that keeps it trustworthy.
Charlene Cho, Microsoft AI · Teginder Singh, Google · Taha Jilani and Hari Subramanian, Otsuka
Co-moderators: Lacey Harbour and Marla Phillips
What are Notified Body auditors really looking for?

Melissa Di Buono-Russo
TÜV Rheinland North America

Laura Handy
BSI
Audit & inspectionSession 7
Inside the Risk-Based Audit: A Notified Body's Approach
Experienced Notified Body auditors show how they use your risk management file as the roadmap, decide what to examine and how deeply, and connect findings across the lifecycle.
Melissa Di Buono-Russo, TÜV Rheinland North America · Laura Handy, BSI
Moderator: Colleen Watson, Thermo Fisher Scientific
Global strategySession 8
Global Perspective: The Forces Reshaping Our Industry
Supply decisions, pricing pressure, humanitarian access and where innovation capital flows. None are set inside your quality system, but all of them determine what it must deliver.
Gerard (Jerry) Greco, Former CQO, Baxter · Anil Sawant, Former CQO, Merck
Moderator: Marla Phillips, Pathway for Patient Health