James Wabby
Global Head, Regulatory Affairs (CoE), Emerging Technologies, Combination Products and Devices
AbbVie
Over 19 years of experience in many facets of regulatory affairs, quality compliance and quality operations within the GxP regulated environment pertaining to Emerging Technologies and Combination Products. Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs regarding CMC Global Dossiers/Global Device Regulatory Strategies, EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC), 21 CFR Part 3 and Part 4 - Combination Products, CE Marking, ISO 13485:2016/MDSAP, International Regulatory Affairs, Product Development - (Design Control, Risk Management and Human Factors Engineering), Acquisitions/Divestitures and represents AbbVie as the U.S Agent regarding FDA matters for international medical device facilities.
In addition, lectures at various symposia, is the Chairman of the DIA Combination Products Committee, chairs various global combination products conferences, participates in regulatory panel discussions within the industry and is an adjunct assistant professor at USC – School of Pharmacy - Regulatory Science Programs.