November 6, 2017
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
Rockville, MD 20852
Overview
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
- Expo
- Mutual Recognition
- GDUFA II - Preparation for GDUFA II Implementation
- OPQ Update
- Patent and Exclusivity
- REMS - Update and Strategies
USP Presenters
USP will host the USP Workshop on November 6. USP representatives will provide updates on the latest USP services available such as publications, Reference Standards, and opportunities for involvement.
Robert Femia: Welcome & Intro
Horacio Pappa: Analytical Procedure Lifecycle and Statistics applied to analytical procedures/general chapters
Kahkashan Zaidi: Elemental Impurities
Mike Ambrose: Research and Innovation activities