March 30-Apr 1, 2011 - ICON plc

AGENDA AT A GLANCEWednesday March 30, 20118:00 Workshop Registration & Morning Coffee, Sponsored by9:00 Workshops Begin10:30 Networking Break12:00Luncheon for Workshop Participants & Main Conference Registration1:00 Main Conference Opens – Chairpersons’ Opening Remarks1:30 Regulatory Keynote: Clinical Partnerships at a Crossroad-The Intersection of Quality and Oversight2:15 A Sponsor Outsourcing Dilemma: Reducing Micro-Management of CROs while Maintaining Effective Quality Oversight3:00 Grand Opening of the Partnerships Hall- Networking Break3:30 Pharmerging Markets Launch the Evolution – Identify the Growth Opportunities for the Global Pharmaceutical Sector3:55 Global Partnerships Meeting Highlights – Europe, APAC, and Latin America4:20 Stakeholders Debate Operational Long Term Strategies for Profitability and Growth in Global Clinical Trials5:15 This is Emerging Market Jeopardy!6:00 Opening Day Reception in the Partnerships HallThursday March 31, 20118:00-8:45 Market Insight Roundtable Discussions & Morning Coffee in the Partnerships Hall9:00 Chairpersons’ Recap of Day One9:15 An Action Plan for Business Growth – Implement Changes to Adapt to the Increased Cost of Drug Development9:45 Fast Money Showdown – Debate Pipeline Trends and Investment Opportunities10:30 Networking Break in the Partnerships Hall11:00 SCORE Track Sessions and Market Insight RoundtablesS trategic Sourcing11:00-11:45 Wall Street Outlook- 2011Forecast and Analysis ofOutsourcing Trends11:45-12:30 Sponsors & CROs Unplugged-Assess the Impact of M&A on YourOutsourcing StrategyC ost & ContractManagementContract Approach andDevelopment – Key NegotiationStrategies to Help You BetterManage Your Clinical TrialsStructure Delivery Expectations inEmerging Markets – Responsibility,Liability, and Accountability12:30-1:30 Luncheon in the Partnerships Hall1:30 SCORE Tracks Continue1:30-2:15 Shared Risk Partnerships Spotlight Streamline Resource Management– How Sponsors Track ResourceUtilization in Development AcrossTheir Operational and ScientificFunctions2:15-3:00 Virtual Drug Development in aResource-Challenged Environment3:00-3:45 The Value of Strategic Alliancesvs. Transactional CRO-SponsorRelationshipsReconfigure Payment andContracting Strategies in Lightof Fair Market ValuePositively Influence Study TimeCompletion in Global Trials3:45 Networking Break in the Partnerships Hall4:15 Past Present and Future of Clinical Trial Outsourcing5:00 Create and Manage Transformational Change – How Do We Make the Switch?6:00 20th Partnerships Celebration – Featuring a Special Guest Performance, brought to you byO perational ExcellenceBest Practices for How to ManageYour Global Teams and RetainValue While OutsourcingAssess the Impact of IndustryConsolidations on ChangeManagement and Your OutsourcingOperational ModelClinical Trial Feasibility –Roadmap to Achieving Value andReturn on InvestmentStrategic Sponsor-Site PartnershipModels – Improve Site Selectionand Recruiting in a CollaborativeEnvironmentOutsourcing Phase IVObservational Studies: A DifferentAnimal?R egulatory Compliance& Quality OversightProactive GCP Compliance andQuality Management Systems –Ensure Quality is Stepping Up andStaff is Stepping BackThrough the Eyes of a Site: WhatDoes Quality Mean to Me?Globalize Regulations for ClinicalData Collection and SubmissionInspection Readiness Strategy inan Era of Heightened Scrutiny ofForeign Clinical Trials – PrepareYour Company and CRO forFDA Inspections, Auditing andMonitoring of the SiteAchieve Compliance with theSunshine Legislation Act on YourStandardized Disclosure PracticesE -Clinical TechnologiesUtilize Electronic Health Recordsin Clinical Research and DrugDevelopmentAchieve Closer Integrationof Clinical Operations Data(EDC, IVRS, CTMS) to ImproveQuality and Optimize ClinicalOutcomesUnderstand How to EffectivelyLeverage Technology to OptimizeYour Outsourcing StrategiesThe Evolution of CROs –Convergence of Serviceand Technology ProvidersBuild Strategic Partnerships byLeveraging Data ManagementProvider Experiences to ImproveOnboarding, Training, Governance,and ContractsFriday April 1, 20117:00-8:00 Stand Up 2 Cancer Morning Yoga8:00-8:45 Market Insight Roundtable Discussions & Morning Coffee in the Partnerships Hall9:00 Chairpersons’ Recap of Day Two9:15 Inspirational Patient Advocate Perspective with MLB Legend Curt Schilling9:45 Leverage the Value of Your Technology – Explore How the Patient will be the Game Changer for Clinical Drug Development10:30 Networking Break in the Partnerships Hall11:00-12:30 SCORE Track Sessions and Market Insight RoundtablesS trategic SourcingC ost & ContractManagementO perational ExcellenceR egulatory Compliance& Quality OversightE -Clinical Technologies11:00-11:45 Committing to Two Partners –A Look at the BMS IntegratedStrategic Sourcing InitiativeNegotiation Strategies – How toBest Define Responsibilitiesbetween Sponsors, Sites, andCROs to Avoid AccountabilityDisputesThe Changing Role of Central Labsand Implications for Outsourcing– Major Developments, FutureTrends, and Global ConsiderationsImplement a ComprehensiveClinical Trial Drug Safety Programand Improve Quality from ClinicalDevelopment to Post-ApprovalOptimize the Vendor-SponsorRelationship with ePRO11:45-12:30 Co-Development Between Sponsorand CRO: Transformational orConflict of Interest?Key Legal Considerations in GlobalOutsourcing – Use Critical Tacticsto Create Effective ContractsBest Practices for PatientRecruitment and Retention inClinical TrialsNext Generation Post-MarketingResearch (PMR) – Meet RegulatoryStandards and Enhance PatientSafety – Risk Maps, Registries,and REMSProactive Medical Monitoring –Planning for Success throughBetter Safety, Design, andEnrollment12:30-1:30 Luncheon in the Partnerships Hall1:30 Strategy is Innovation: Solving the Execution Challenge2:15 Industry Future – C-Suite Fireside Chat3:00 Partnerships Hall of Fame Awards Ceremony3:20 Main Conference Concludes3:30-5:00 Post-Conference Intensives4Register Now! Call +1 888.670.8200 US; +1 941.951.7885 Int’l • E-mail register@iirusa.com