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)

• Addn’l Speaker(s): TBA

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.

• 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)

During this time, our Vendor Partner Sponsors will lead three 15-minute sessions to share insights and solutions. Attendees will self-select which rooms they would like to visit. Thank you to our Vendor Partner Sponsors in this session:

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.

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

• Speaker: Janine Medina, CEO and Executive Director, Biohacking Village

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.

• Moderator: Chris Dible (Senior Director, Quality Systems, Stryker)

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

Your biggest AI risk isn't the technology—it's how comfortable your people have become with it. Shadow AI, deskilled experts, and data kept too long all live in the gap that policies alone can't close. This session pinpoints what makes AI risk different, why the answer is human before technical, and where your people fit. Walk away with ideas you can use today.

• Moderator: Hugo Ta (Associate Director, Quality Policy and Advocacy, Gilead Sciences)

During this time, our Vendor Partner Sponsors will lead three 15-minute sessions to share insights and solutions. Attendees will self-select which rooms they would like to visit. Thank you to our Vendor Partner Sponsors for this sesssion:

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. An experienced Notified Body auditor shares 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: TUV Rheinland North America

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

Australia's TGA has reorganized its entire compliance approach to be driven by data, intelligence, and emerging risk. In this session, TGA shares how it prioritizes risk, how digital monitoring shapes where it acts, and how risk-weighted enforcement works in practice. This is a rare window into the regulator's logic—and a chance to understand how anticipating risk-based oversight can strengthen your own approach.

• Moderator: Marla Phillips (Pathway)

Speaker: Marla Phillips, Pathway for Patient Health