Agenda

Agenda

Oct. 3
1:00-1:10Introductory remarksGil Roth • PBOA
1:10-2:00End-market Demand TrendsElliot Vaughn • Boston Consulting Group
2:00-2:45Current State of Pharma OutsourcingKate Hammeke (ISR Reports) • Eric Langer (BioPlan Associates) • Jim Miller (PharmSource)
2:45-3:15Legislative OverviewBrent Del Monte • BGR Government Affairs
3:15-3:45FDA: Quality Metrics Q&ATara Gooen Bizjak • FDA
3:45-4:30FDA: What's in Your Warning Letter?Paula Katz, w/Tom Cosgrove • FDA (invited)
4:30-5:00FDA: EMA and Mutual Recognition Q&ANiraj Mehta • FDA
5:30-7:00COCKTAIL RECEPTIONSponsored by TraceLink
7:30-10:30OFF-SITE DINNERAt Rock-Bottom Brewery in Bethesda, MD
Oct. 4
7:00-8:00BREAKFAST
8:00-8:10Introductory remarksGil Roth • PBOA
8:10-8:45FDA: Inspectorate and the Role of CMO/CDMOsAlonza Cruse • FDA
8:45-9:15FDA: DSCSA/Serialization and CMOsIlisa Bernstein • FDA
9:15-9:45PBOA Regulatory PrioritiesHarry Jeffreys • Catalent (on behalf of PBOA Quality Technical Group)
9:45-10:15COFFEE BREAK
10:15-10:45Trends in Facility Design and ExpansionSam Halaby • IPS
10:45-11:15Working with Drug Innovators to Safely Handle Potent APIsRobert Sussman • SafeBridge Consultants
11:15-11:45Continuous vs. Flexible ManufacturingFernando Muzzio • Rutgers University
11:45-12:30M&A and Investment Trends in CDMO & Pharma ServicesDaniel Cohen • RBC
12:30-1:15LUNCH
1:15-2:00Employee Retention and EngagementDeborah Howard • Guiding Change Consulting
2:00-2:45PBOA Priorities: Post-FDARAGil Roth • PBOA
2:45-2:50Closing remarks

Visit our Speakers page for bios of our speakers and panelists.

 Speakers and times subject to change