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Session Chair(s)
Wayne Pines
President, Health Care
United States
Speaker(s)
CDER Update
Thomas W. Abrams, MBA, RPh
Former FDA, United States
Retired, Director, Office of Prescription Drug Promotion, OMP, CDER
FDA Update: Recent Enforcement Actions and Guidances–Update on eSubDraft Guidance
CDR Roberta Szydlo, MBA, RPh, RAC
FDA, United States
Office of Prescription Drug Promotion, CDER
CBER Update
Sonny Saini, PharmD
FDA, United States
Regulatory Health Project Manager
CDRH Update
Deborah Wolf, JD
FDA, United States
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH
CVM Update
Thomas J. Moskal, DVM
FDA/CVM, United States
Veterinary Medical Officer
An Introduction to Combination Products
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC