James Wabby

James Wabby serves as an Adjunct Assistant Professor at the University of Southern California (USC) School of Pharmacy, Department of Regulatory and Quality Sciences, while concurrently leading Global Regulatory Affairs for Emerging Technologies and Combination Products at AbbVie Inc. as Volwiler Senior Research Industry Fellow in Regulatory Science.

His educational credentials include:

• BSc. in Biology from Duquesne University
• MHMS in Health Law and Policy from Duquesne University
• Certificate in Health Law and Life Science Regulatory Compliance from Seton Hall University Law School
• RAPS Executive Development Program Certificate from Northwestern University Kellogg School of Management

With 22 years of GxP regulatory experience, Wabby specializes in Medical Devices, Combination Products, and Digital Medicine. His expertise encompasses EU MDR/IVDR compliance (as PRRC), 21 CFR Parts 3-4, ISO 13485:2016/MDSAP, and Product Development including Design Control and Risk Management. He provides strategic regulatory counsel across AbbVie's therapeutic franchises and represents the company as U.S. Agent for FDA matters.

His scientific recognition includes:

• Volwiler Senior Research Industry Fellow – Regulatory Science

Wabby actively shapes global regulatory standards as Chairman of the DIA Combination Products Committee, ISPE Combination Products Committee, and DIA Translational Device Technologies Committee. He chairs international conferences, moderates regulatory panels, and participates in industry organizations including RAPS, AAMI, and PDA. At AbbVie, he leads the Center of Excellence for Emerging Technologies and Combination Products.

No information regarding student advising or research grants was provided in the source material.