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

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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