James Wabby


1st January, 1970

James Wabby

Over 19 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Device, Digital Medicine and Combination Product areas. In addition, an adjunct assistant professor at USC – School of Pharmacy – Regulatory and Quality Sciences.

Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:

  • CMC Global Dossiers and Global Device Regulatory Strategy Registrations
  • EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
  • 21 CFR Part 3 and Part 4 – Combination Products
  • CE Marking
  • ISO 13485:2016/MDSAP
  • Product Development – Design Controls
  • Risk Management
  • Human Factors Engineering
  • Acquisitions/Divestitures
  • Import/Export – U.S. Agent
  • Production Controls
  • Regulatory Inspection Management
  • Materiovigilance
  • Health-Care Related Laws and International Regulations

SPONSORSHIP OPPORTUNITIES

Arena’s business-to-business events offer a myriad of opportunities for sponsors and exhibitors to drive their businesses forward.
Our sponsorship packages help companies educate ther target market on key industry issues and spread brand awareness throughout the
industry.

If you want to discuss how we can help you generate leads and add-value to your corporate and brand image please contact:

Paul Adams
pauladams@arena-international.com
+44 (0)20 7936 6948

Speaker opportunities

We identify and invite individuals we believe to be the best speakers in the market, if you think you can make a difference to the quality of our events please contact:

Chloe Roberts
E: Chloe.Roberts@arena-international.com
T: +44 (0)207 936 6822