Each year, more than 700 generic industry professionals attend this unique educational conference. Hear presentations from experts from the FDA, industry and academia as they address key regulatory and technical issues impacting the generic industry.
Key Conference Objectives
• ANDA Operations Update
• CDER Update
• OGD Update
• Data Standards Update
• Industry Perspective: Successful Drug Development Strategies
• Inspections and the ANDA Review -Integration of Three Key Offices: OPF/OC/ORA
• Office of Research and Standards
• OGD - Office of Regulatory Operations Filing Review
• Mutual Recognition
• GDUFA II - Preparation for GDUFA II Implementation
• OPQ Update
• Patent and Exclusivity
• REMS - Update and Strategies
The Generic Pharmaceutical Association (GPhA) is the nation’s leading trade association for manufacturers and distributors of generic prescription drugs, manufacturers of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.