Securing the Future: Patient Safety and Supply Chain Integrity in Pharma
- Keynote sessions offering a deep dive into crucial industry issues such as counterfeit products, supply chain integrity, quality control, and the emerging role of AI.
- Celebrate and Network with industry peers during Rx-360’s 15 Year Anniversary Gala
Thursday and Friday, September 21 – 22
JW Marriott in Washington, D.C.
Learn from Experts and Innovators
Geoffrey Potter, Esq.
Partner, Patterson Belknap Webb & Tyler LLP
Guy Villax
Hovione (Board Member)
Anthony Lakavage
US Pharmacopeia
Shawnee Delaney
CEO, Vaillance Group
Leigh Verbois, Ph.D.
Director, FDA/CDER/OC/OSDIR
Milind Ganjawala
FDA/CDER/OC/OMQ
Michael de la Torre
Redica Systems
Ben Mills
Senior Director, Operations Quality and Audits, Rx-360
Engage in Day 2 Specialty Tracks Lead By Industry Professionals
Equip yourself with cutting-edge knowledge, foster valuable connections, and ignite your passion for patient safety. Buy Tickets Today.
AGENDA
Day One: September 21st
General Session
| Time | Speaker | Topic |
| 8:15am | Breakfast in Main Outer Area | |
| 9:00am | Welcome | |
| 9:15am | Geoffrey Potter, Esq. Partner Patterson, Belknap Webb & Tyler LLP | Counterfeit Products in the Pharmaceutical World |
| 10:30am | Break | |
| 10:45am | Guy Villax, Hovione (Board Member) | Why is Pharmaceutical Supply Chain Integrity Important? |
| 11:45am | Lunch in Main Outer Area | |
| 12:45pm | Anthony Lakavage, US Pharmacopeia | Intersection of Quality and Supply Chain Security |
| 1:45pm | Break | |
| 2:00pm | Leigh Verbois and Milind Ganjawala, FDA CDER | FDA Presentation on How They View Supply Chain Integrity and What is on the Horizon |
| 3:15pm | Michael de la Torre, Redica Systems | “Beyond Chat GPT: The Future of AI in Quality and Regulatory” |
| 4:15pm | Adjourn | |
| 6:00pm | Gala/Dinner | Speaker is Shawnee Delaney |
Day Two: September 22nd
Two Tracks
| Time | Track One / Rx-360 Working Groups | Track Two / Joint Audit Program |
| 8:15am | Breakfast | Breakfast |
| 8:45am | Welcome | Welcome |
| 9:15am | An Overview of Materials and Practices in Cell & Gene Therapy (Arvind Srivastava & Raj Shah from Avantor) | The Value of the Rx-360 Joint Audit Program (Ben Mills Presenter) |
| 10:00am | Data Integrity Manual and Future Planning (Jim Henderson from Eli Lilly Co.) | NewAge AdvantaPure: Quality Journey to Support Life Savings Medicines (Ken Baker CEO Presenter) |
| 10:45am | Break | Break |
| 11:00am | Supplier Quality Working Resource Overview (Karla Longo Gouveia from Merck, Jennifer Goodman from Avantor) | GSK: Case Study on the Value of Joint Audits (Rob Smith from GSK Presenter) |
| 11:45am | DSCSA Implementation (Presenter Matt Price from Partnership for DSCSA Governance) | Rx-360’s Standardized Supplier Questionnaires – Introduction to the SAQ Working Group (Christoph Hartmann, Merck KGaA) |
| 12:30pm | Adjourn & Thank You in General Assembly Room | Adjourn & Thank You in General Assembly Room |