Andrew S. Verderame, MBA, RAC is a Partner in PharmaLex US, which is a global consulting company providing regulatory, pharmacovigilance/epidemiology/risk management, quality/compliance, statistics and pharmaceutical development services to pharma and biotech companies of all sizes. He is a leader of the US-based staff providing FDA-specific guidance and consulting services. Clients benefit from his wealth of experience, which includes leading over one hundred meetings with FDA, managing multi-national regulatory teams for both large and small pharmaceutical companies, several New Drug Application approvals, and presenting to FDA Advisory Committees, with successful outcomes.
During his career he secured the FDA approval for the first bioterrorism application (Cipro/Anthrax) which became the basis for the FDA Animal-Rule guidance and was also the first industry representative ever invited to speak at the Project Manager Staff Forum at FDA.
Tuesday, September 24
1:00 PM – 1:55 PM