Conference Agenda

Regulatory Agencies are identifying ways to reduce the burden for your product's entry into their market - without compromising patient safety. Bring this intel back to your organization as the foundation for your Market Access/Regulatory Strategy.

• Speaker: Martha Betz, Ph.D. (FDA Associate Director, Post Market Programs, CDRH)

• Speaker: Ashley Boam (FDA Director, Office of Policy for Pharmaceutical Quality, CDER)

• Speaker: Stephen Maddocks (MHRA)

• Moderator: Marla Phillips (Pathway for Patient Health)

Hear first-hand how executives are measuring "Proof of Value" and "Trust as an Outcome" while transforming operating models. Gain insight on how you can advance the Economics of Quality to mobilize enterprise effectiveness for the patients you serve.

• Panelist: Paul Foley (Senior Vice President, Head of Manufacturing, Gilead Sciences)

• Panelist: Elaine Shannon (President, Global Supply & Quality, Takeda)

• Panelist: Bala Sreenivasan (Senior Vice President Global Supply and Value Chain Management, Merck)

• Moderator: Peter Shearstone (Vice President & Chief Quality Officer, MedTech at Johnson & Johnson)

This actionable session will demonstrate "how" to drive risk-decision harmonization throughout every level of your organization that is aligned with your Enterprise Risk Tolerance. Every employee will be empowered to think like their CEO.

• Speaker: Nidia Acevedo (Senior Vice President, Global Quality Compliance, Eli Lilly)

• Moderator: Ian Hooley (Senior Director Quality Assurance, Zimmer Biomet)

This fast-paced “Tech Demo Rounds” session gives you 3 opportunities to experience 15-minute demos from our Vendor Partner Sponsors who have innovative solutions to advance your organization. Rotate through the following “rooms”:

aizon

Basil Systems

Redica Systems

Learn how preventive measures and quick action are both vital to a "Cyber Preparedness Plan" that enabled a company to protect the patients they serve - and is one in which regulators and shareholders expect. With criminal sophistication on the rise, this is a session you can't afford to miss.

• Speaker: Nina Alli (CEO and Executive Director, Biohacking Village)

• Moderator: Lacey Harbour (Vice President, Quality and Regulatory Advancement, Pathway)

Agility and quality are a powerful partnership. This session shows how a future-ready QMS turns dependable quality into organizational speed, making Quality the spark that mobilizes the entire enterprise. You'll leave with practical strategies ready for immediate implementation.

• Speaker: Peter Shearstone (Vice President & Chief Quality Officer, MedTech at Johnson & Johnson)

• Moderator: Marla Phillips (Pathway for Patient Health)

AI is outpacing the standards meant to govern it. Explore where we are and what's coming: standards gaps, the tech giant messages making waves, a practical decision flow, how to validate, and why AI's drive to be "right" can rewrite your data. You'll leave understanding the AI management system (locked prompts, traced data and version monitoring) that keeps AI trustworthy.

• Speaker TBA

This fast-paced “Tech Demo Rounds” session gives you 3 opportunities to experience 15-minute demos from our Vendor Partner Sponsors who have innovative solutions to advance your organization. Rotate through the following “rooms”:

ComplianceQuest

Modicus Prime

Phanero

The shift to risk-based inspections is changing how your operations are being evaluated—moving from a systems checklists to a risk management assessment. Experienced Notified Body auditors share how they use your risk management file as the roadmap, decide what to examine and how deeply, and connect findings across the lifecycle—leaving you with practical techniques to strengthen your operations.

• Speaker: Melissa Di Buono-Russo (Director - Medical Audit, TUV Rheinland North America)

• Speaker: Laura Handy (Service Delivery Manager, BSI)

• Moderator: Colleen Watson (Senior Director, Regulatory Affairs, Thermo Fisher Scientific)

Supply decisions, pricing pressure, humanitarian access, and where innovation capital flows — none of these are set inside your quality system, but all of them determine what it must deliver. Gain insight on how to translate global pressure strategy with reliable systems - an integral source of business advantage when the ground underneath the industry keeps moving.

• Speaker: Gerard (Jerry) Greco (Former CQO - Baxter)

• Speaker: Anil Sawant (Former CQO - Merck)

• Moderator: Marla Phillips (Pathway for Patient Health)

Speaker: Marla Phillips, Pathway for Patient Health