The theme of the 2014 Annual Meeting is The Leading Edge of Pharmaceutical Innovation. ISPE continues to lead our industry in groundbreaking initiatives addressing important issues such as Drug Shortages and Quality Metrics. Over the next four days, you will have the unique opportunity to learn more about the latest ISPE initiatives and hear from industry experts. The ISPE Drug Shortages Prevention Plan will be officially released on Tuesday afternoon. The Plan was developed by the ISPE Drug Shortages Taskforce, building upon ISPE’s landmark 2013 study on drug shortages. The Plan lays out how industry can best prevent drug shortages from occurring to help ensure a robust, resilient and reliable supply of necessary and life-saving medications to patients worldwide. Also on Tuesday afternoon, the ISPE Quality Metrics session will provide a comprehensive update of quality metrics programs designed to support the FDA initiative, as required by FDASIA. FDA has been invited to give the status of their thinking and perspective on quality metrics. The ISPE Quality Metrics project team will provide the latest information on the status of the ISPE Quality Metrics pilot program launched in June of this year. Our thought-provoking keynote session for today includes, John Bournas, ISPE’s new CEO and Dinesh Thakur, Executive Chairman at Medassure Global Compliance Corporation, who will speak about securing the pharmaceutical supply chain. Schedule-at-a-Glance

07.00 – 19.00 Registration Open Promenade Level
12.30 – 13.30 102-QUALITY SYSTEMS-Oper­ations-Focused Quality System Optimization Forum 15(Pool Level)
13.00 – 15.00 211-MANUFACTURING TECH­NOLOGY-Closure Processing: Container Integrity, Blow/Fill/Seal Forum 9(Pool Level)
13.00 – 15.00 315-REGULATORY & COMPLI­ANCE-Developments in Global Harmonization Forum 11(Pool Level)
13.00 – 15.00 319-REGULATORY & COMPLI­ANCE-Risk Part I Forum 7(Pool Level) Maybe
13.00 – 15.00 712-MANUFACTURING FACIL­ITIES & DESIGN-Operational Excellence: Facility Master Plan­ning, Manufacturing Capacity and Cost Modeling Forum 12(Pool Level)
13.00 – 15.00 716-MANUFACTURING FACIL­ITIES & DESIGN-Case Study: New High Purity Water System Technologies Deliver Reliability & Sustainability for GSK Forum 18(Pool Level)
15.30 – 17.00 Opening Keynote Milano Ballroom (Promenade Level
17:00-19:00 Welcome Reception in Exhibit Hall Forum Ballroom(Pool Level)