Jeffrey MocnyVice President, Quality and Regulatory Strategy at AbzenaSpeaker
Profile
With 20+ years of experience in regulated pharmaceutical and medical device product development in exploratory and late phase research, Intellectual Property, analytical development and regulatory strategic consulting, Dr. Mocny has developed marketed products and worked with sponsors large and small to launch their own.
At Abzena, Dr. Mocny is a strategist, product development and regulatory guidance to early and late phase development projects by leveraging quality management and risk mitigation approaches. He works with sponsors in all therapeutic areas to use regulatory strategy as a business tool to move quickly to market. Jeff and his team provide a consultative approach to sponsor relations, devises strategic roadmaps that follow best practices and spearheads collaborative problem resolution.
Agenda Sessions
Considerations for drug developers on manufacturing data capture with a view to an anticipated structured review by Regulators for IND and BLA Filings
, 12:40pmView Session