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Clinical Operations (24)

• Shape Your Cost with Hard and Soft Coverage Analysis Trends Session Chair : Kelly M. Willenberg	Mon, June 24 11:00AM CME, IACET, PMI, RN
  Trials, Studies and Programs: Diverse Operational Approaches to Generating Evidence in the Late-phase Environment Session Chair : Gary Coward	Mon, June 24 11:00AM CME, IACET, RN
  Implementing Performance Metrics: How Investigator Sites Can Pave the Way for Running Successful Clinical Trials Session Chair : Christine K. Pierre	Mon, June 24 2:30PM CME, IACET, RN
  Global Clinical Trials: The Role of Emerging Markets Session Chair : Nancy Meyerson-Hess	Mon, June 24 2:30PM CME, IACET, RN
  Leveraging In-Pharmacy Education to Improve Patient Comprehension and Access to Clinical Trials Session Chair : Kenneth A. Getz	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Is This Trial Worth It? A Panel Discussion for Sites and Project Managers Session Chair : Rodney William Butt	Tue, June 25 8:00AM CME, IACET, PMI, RN
  Optimizing Trial Feasibility by Leveraging Electronic Health Record (EHR) Data and Engaging Investigators and Patient Advocacy Groups Session Chair : Lisa Palladino Kim	Tue, June 25 10:15AM ACPE, CME, IACET, RN
  Domestic and Global Trends in Clinical Trial Budgeting Session Chair : Frank J Cattie	Tue, June 25 10:15AM CME, IACET, PMI, RN
  Enrollment Analytics: Moving Beyond the Funnel Session Chair : Paul Ivsin	Tue, June 25 1:45PM CME, IACET, RN
  Taking the Measure of Metrics Session Chair : Nikki Dowlman	Tue, June 25 1:45PM CME, IACET, PMI, RN
  Approaches to Risk-based Monitoring Session Chair : Jeffrey S. Handen	Tue, June 25 4:00PM CME, IACET, RN
  Evaluating Sites for Optimum Site Selection and Performance Session Chair : Scott R Martin	Tue, June 25 4:00PM CME, IACET, PMI, RN
  Clinical Trial Design for Optimal Patient Recruitment and Retention Session Chair : William W. Gwinn	Wed, June 26 8:00AM CME, IACET, RN
  Understanding Operational Feasibility: A Discussion of Current Methodologies, Primary Research Limitations and Opportunities Session Chair : Nicole Turner	Wed, June 26 8:00AM CME, IACET, RN
  Study Startup Symposium Session Chair : Mary Jo Lamberti	Wed, June 26 10:15AM CME, IACET, RN
  Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives Session Chair : Donna W. Dorozinsky	Wed, June 26 10:15AM CME, IACET, RN
  Driven by Data: More Effective Strategies to Reach Your Patient Recruitment Goals Session Chair : Julie Parmelee	Wed, June 26 10:15AM CME, IACET, RN
  Using Big Data to Design Smarter Studies Session Chair : Jane E. Myles	Wed, June 26 1:45PM CME, IACET, RN
  Innovative Ways of Working with Patients to Make Clinical Research More Productive, Less Costly and Less Burdensome for the Patient Session Chair : Elisa F. Cascade	Wed, June 26 4:00PM CME, IACET, RN
  Overcoming Unique Challenges of Pediatric Studies Session Chair : Kathryn Elaine Bohannon	Wed, June 26 4:00PM CME, IACET, RN
  Parents as Partners: Engaging Caregivers for Pediatric Trials Session Chair : Donald Sickler	Thu, June 27 9:00AM CME, IACET, RN
  Hot Topics in Clinical Supplies Session Chair : Chuck Harris	Thu, June 27 9:00AM IACET
  Impact and Interventions Related to FDASIA: Increasing Diversity in Clinical Trials Session Chair : Brenda Jamerson	Thu, June 27 10:45AM CME, IACET, RN
  CRA’s Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment Session Chair : Maria del Pilar Torres	Thu, June 27 10:45AM CME, IACET, RN

Clinical Safety and Pharmacovigilance (18)

• Electronic Health Records (EHRs) in Signal Detection and Evaluation Session Chair : Preciosa M. Coloma	Mon, June 24 11:00AM ACPE, CME, IACET, RN
  Narrative Medicine and Pharmacovigilance Session Chair : Michael A. Ibara	Mon, June 24 11:00AM CME, IACET, RN
  The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance Session Chair : Sabine Brosch	Mon, June 24 2:30PM CME, IACET, RN
  Characterizing Drug Shortages and Their Causes: Anticipating Future Trends Session Chair : Kenneth A. Getz	Mon, June 24 2:30PM ACPE, CME, IACET, RN
  Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting Session Chair : Judith M. Kramer	Tue, June 25 8:00AM CME, IACET, RN
  Social Media, Mobile Applications and Patient Support Programs: Challenges and Solutions for Handling Drug Safety Information Session Chair : Arpad Simon	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  EU Update: PROTECT and EnCePP Session Chair : Stella C.F. Blackburn	Tue, June 25 10:15AM CME, IACET, RN
  Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and Benefit-risk Evaluations Session Chair : Reingart Bordel	Tue, June 25 1:45PM CME, IACET, RN
  Quality Assurance for Signal Detection Programs Session Chair : Elizabeth E. Garrard	Tue, June 25 1:45PM CME, IACET, RN
  Risk Management in the US, EU and Japan: The Challenges of Diversity Session Chair : Nancy A Dreyer	Tue, June 25 4:00PM CME, IACET, RN
  Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance Session Chair : Niklas Noren	Wed, June 26 8:00AM ACPE, CME, IACET, RN
  Pharmacovigilance Update for Japan, Developing Asia and Latin America Session Chair : Stewart Geary	Wed, June 26 8:00AM CME, IACET, RN
  An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection Session Chair : Ram Tiwari	Wed, June 26 1:45PM CME, IACET, RN
  Developing a Patient Aid to Make Information about Treatment Benefits, Harms and Uncertainties Meaningful to Individual Patients and Enhance Their Decisions Session Chair : Marcin Boruk	Wed, June 26 4:00PM ACPE, CME, IACET, RN
  Herbal-induced Liver Injury (HILI): How That May Impact Rx Benefit-Risk Session Chair : Pradip K. Paul	Wed, June 26 4:00PM CME, IACET, RN
  Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can? Session Chair : Mitch Miller	Thu, June 27 9:00AM ACPE, CME, IACET, RN
  Coding with Confidence Session Chair : Judy E. Harrison	Thu, June 27 9:00AM CME, IACET, RN
  Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations Session Chair : Jeffrey Heilbraun	Thu, June 27 10:45AM ACPE, CME, IACET, RN

Communities Showcase (9)

• How Can Translational Medicine Fill the Gaps in Life Sciences Industries? Session Chair : Aamir Shahzad	Mon, June 24 11:00AM CME, IACET, RN
  Defining Clinical Trial Innovation: Challenges and Opportunities for 2013 Session Chair : Susan K. Nunchuck	Mon, June 24 2:30PM CME, IACET, RN
  Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball Session Chair : Margaret Gurian	Tue, June 25 8:00AM CME, IACET, RN
  Achieving Innovative Technology Results Session Chair : James O'Keefe	Tue, June 25 10:15AM CME, IACET, RN
  First-in-Human Studies: How Much Complexity Is Too Much? Session Chair : Royce A. Morrison	Tue, June 25 1:45PM CME, IACET, RN
  The Evolving Clinical Trial Disclosure Global Landscape Session Chair : Sarah Doyle Larson	Tue, June 25 4:00PM CME, IACET, RN
  Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols Session Chair : Helle Gawrylewski	Wed, June 26 8:00AM CME, IACET, RN
  Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs Session Chair : Melvyn Greberman	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Current Regulatory Landscape Impacting Medical and Scientific Communications Session Chair : Mary K. Sendi	Wed, June 26 4:00PM ACPE, CME, IACET, RN

Executive Program (2)

• Reinventing the R&D Business Model: Heeding the President's PCAST Report on Innovation Session Chair : Kenneth I. Kaitin	Tue, June 25 1:45PM CME, IACET, RN
  Where Research, Medicine and Care Converge: A CMO Roundtable Discussion Session Chair : Michael Rosenblatt	Tue, June 25 4:00PM ACPE, CME, IACET, RN

Global Regulatory (11)

• CBER Town Hall Session Chair : Karen Midthun	Mon, June 24 11:00AM CME, IACET, RN
  European Town Hall: Implementation of New Safety Legislation and Other Hot Topics Session Chair : Guido Rasi	Mon, June 24 11:00AM CME, IACET, RN
  Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall Session Chair : Nobumasa Nakashima	Tue, June 25 8:00AM CME, IACET, RN
  Convergence in Regulatory Science Across the Strait Session Chair : Ning Li	Tue, June 25 1:45PM CME, IACET, RN
  Korea Forum: Introduction to the Korean Ministry of Food and Drug Safety (MFDS) and Government R&D Program Session Chair : Yil-Seob Lee	Tue, June 25 4:00PM CME, IACET, RN
  FDA-Health Canada Regulatory Cooperation Council (RCC) Town Hall Session Chair : Louise Dery	Wed, June 26 8:00AM CME, IACET, RN
  Canadian Approaches to Regulatory Modernization and International Engagement Session Chair : Agnes V. Klein	Wed, June 26 1:45PM CME, IACET, RN
  Challenges for Stable Supply of Drugs and International Cooperation Session Chair : Nobumasa Nakashima	Wed, June 26 4:00PM ACPE, CME, IACET, RN
  Latin America Town Hall Session Chair : Alejandro Bermudez-del-Villar	Wed, June 26 4:00PM CME, IACET, RN
  CDER Town Hall: Part 1 of 2 Session Chair : Nancy D. Smith	Thu, June 27 9:00AM CME, IACET, RN
  CDER Town Hall: Part 2 of 2 Session Chair : Nancy D. Smith	Thu, June 27 10:45AM CME, IACET, RN

Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) (8)

• Using Epidemiologic Methods to Advance Comparative Effectiveness Research Session Chair : Nancy A Dreyer	Mon, June 24 2:30PM ACPE, CME, IACET, RN
  Payer Collaborations with Pharma: Real-world Evidence to Improve Patient Outcomes and Influence the Pipeline Session Chair : Christopher M. Marrone	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Big Data: Impact on Innovation Session Chair : Susan Dentzer	Tue, June 25 10:15AM ACPE, CME, IACET, RN
  Utilizing Electronic Medical Records as an Innovative Methodology for Evaluating Therapeutic Effectiveness Session Chair : Ryan Gifford	Tue, June 25 4:00PM ACPE, CME, IACET, RN
  The Environment for Health Care Decision-making: Collecting, Using and Understanding Comparative Effectiveness Research Session Chair : Kimberly Westrich	Wed, June 26 8:00AM ACPE, CME, IACET, RN
  The 2012 US Payer Landscape: Results from a Survey of Medical and Pharmacy Directors on Comparative Effectiveness Research Session Chair : Richard Alan Brook	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Informing Regulatory and Health Technology Assessment (HTA) Decision-making Processes: An Integrated Approach to Life Cycle Management Session Chair : Larry Liberti	Wed, June 26 4:00PM CME, IACET, RN
  Patient-centered Predictive Modeling and Its Role in Creating a Learning Health System Session Chair : Matthew D. Rousculp	Thu, June 27 9:00AM ACPE, CME, IACET, RN

Innovation Theater (5)

• IntraLinks Innovation Theater: Crossing the Threshold – Clinical Portals from a Site Perspective Session Chair : Intralinks, Inc.	Mon, June 24 1:00PM
  Deloitte Innovation Theater: Race for Real World Data - Outcomes Data and Analytics: Uses, Approach and Issues Session Chair : Deloitte	Tue, June 25 9:40AM
  Cambridge Semantics Innovation Theater: How Can Technology Change the Way Pharmas Handle Risk? Innovations in Drug Safety and Business Development Session Chair : Cambridge Semantics	Tue, June 25 12:15PM
  INC Research Innovation Theater: Innovating Clinical Development Through Data-driven Operational Strategy Session Chair : INC Research, Inc.	Tue, June 25 3:25PM
  SAS Innovation Theater: Picture This: Bringing Clinical Data to Life Session Chair : SAS Institute Inc.	Wed, June 26 12:15PM

Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) (12)

• Practical Considerations for GCP Audits in a Risk-based Environment Session Chair : Michael R. Hamrell	Mon, June 24 11:00AM CME, IACET, RN
  Vendor Management Using Quality by Design and Risk Management Strategies Session Chair : Sherri A. Hubby	Mon, June 24 11:00AM IACET
  Effectiveness Checks in the Clinical Research Setting Session Chair : Cassandra Kennedy	Mon, June 24 2:30PM CME, IACET, RN
  Quality Risk Management: An Old Hat? Session Chair : Beat E. Widler	Mon, June 24 2:30PM CME, IACET, RN
  GCP and Inspection Readiness Session Chair : Marta Haley Fields	Tue, June 25 8:00AM CME, IACET, RN
  GCP Risk-based Monitoring Session Chair : Kathleen Goin	Tue, June 25 1:45PM CME, IACET, RN
  GCPs in Emerging Countries Session Chair : Fred Feldstein	Tue, June 25 4:00PM CME, IACET, RN
  How Will Risk-adapted Clinical Trials Be Inspected? Session Chair : John Poland	Wed, June 26 8:00AM CME, IACET, RN
  FDA/EMA/WHO Collaboration and Cooperation on Good Clinical Practice (GCP), Bioequivalence (BE) and Pharmacovigilance (PV) Inspections Session Chair : Cynthia Kleppinger	Wed, June 26 1:45PM CME, IACET, RN
  Innovations in Proactive Quality Management: Best Practices and Variability in Approaches to Proactive Quality Management Session Chair : Steven B. Whittaker	Wed, June 26 4:00PM CME, IACET, RN
  eSource Symposium Session Chair : Ed Seguine	Thu, June 27 9:00AM CME, IACET, RN
  Protocol Deviations: Avoidable Problems or an Unavoidable Risk Session Chair : Leslie M. Sam	Thu, June 27 10:45AM CME, IACET, RN

Innovative Partnering Models and Outsourcing Strategies (17)

• The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials Session Chair : Denise A Calaprice-Whitty	Mon, June 24 11:00AM CME, IACET, PMI, RN
  Innovative Partnerships for mHealth Session Chair : Nancy Carter-Foster	Mon, June 24 11:00AM CME, IACET, RN
  Implementing Regulatory Outsourcing Partnerships: New Trends and Practices Session Chair : Tracy Tsuetaki	Mon, June 24 2:30PM IACET
  Making CRO-Sponsor Partnerships Work: Executive Roundtable Session Chair : Kenneth I. Kaitin	Tue, June 25 8:00AM IACET, PMI
  Developing and Maintaining Sponsor/CRO Partnership Regulatory Submissions Processes: Challenges and Successes Session Chair : Bill Leslie	Tue, June 25 10:15AM CME, IACET, RN
  Change Order Panel Discussion and Brainstorming Session: Can We Be More Efficient? Session Chair : Moisha Platto	Tue, June 25 10:15AM CME, IACET, PMI, RN
  Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial Session Chair : Mary Ann Sellers	Tue, June 25 1:45PM CME, IACET, PMI, RN
  FDA Collaborations Broaden the Reach of Health Care Messages to Effectively Communicate with the Public Session Chair : Anna M Fine	Tue, June 25 1:45PM ACPE, CME, IACET, RN
  Investigator Budgets Impact on Patient Enrollment and Retention: How to Improve Sponsor/CRO/Site Processes to Increase Productivity Session Chair : Daniel M Ulrey	Tue, June 25 4:00PM CME, IACET, RN
  Evolving to Functional Service Providers (FSP): Successfully Transforming Existing Partnerships into FSP Relationships Session Chair : Andrew Townshend	Wed, June 26 8:00AM IACET
  Unique Nonprofit-Industry Partnerships to Develop and Disseminate Technology Session Chair : Badri Rengarajan	Wed, June 26 8:00AM IACET
  Project Data Sphere: Clinical Trial Data-sharing in Cancer to Accelerate Innovation and Enhance Patient Health Session Chair : Angela L Lightfoot	Wed, June 26 10:15AM ACPE, CME, IACET, RN
  Innovative Strategies for Evolving Sponsor, CRO and Site Alliances Session Chair : Mick O'Quigley	Wed, June 26 10:15AM IACET, PMI
  Towards an Effective Virtual R&D Team for Faster Accessing of the East Asian Market Session Chair : Deborah Chee	Wed, June 26 1:45PM CME, IACET, PMI, RN
  Partnering and Outsourcing Challenges in India: The New Paradigm Shifts Session Chair : Anupama Ramkumar	Wed, June 26 4:00PM CME, IACET, PMI, RN
  Strategic Partnerships: Emerging Models and Their Impact on Drug Development Session Chair : Neil Ferguson	Thu, June 27 9:00AM CME, IACET, PMI, RN
  Transforming Relationships to Adapt to Evolving Organizational Strategic Goals Session Chair : Alison Holland	Thu, June 27 10:45AM CME, IACET, PMI, RN

Late Breaker (3)

• Collaborating to Streamline Drug Development: Are We Making Progress? Session Chair : Douglas J. Peddicord	Wed, June 26 8:00AM CME, IACET, RN
  TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology Session Chair : Craig A Wozniak	Wed, June 26 1:45PM CME, IACET, RN
  TransCelerate’s Collaborative Approach for Site Qualification and Training Efficiencies Session Chair : Megan Schaeffer	Wed, June 26 4:00PM CME, IACET, RN

Medical Communication, Medical Writing and Medical Science Liaison (12)

• Finessing Scientifically Accurate, Comprehensible, Compliant, Clinically-focused Module 2 Summaries of an eCTD-based Submission Session Chair : Nancy R. Katz	Mon, June 24 11:00AM IACET
  The Regulatory Writing Game Show Session Chair : Jessie Wolfe Galson	Tue, June 25 8:00AM IACET
  Innovation and Evolution Within the Medical Science Liaison Role Session Chair : J. Lynn Bass	Tue, June 25 8:00AM IACET
  Preparation of Clinical Study Reports and Summary Documents: Maximize Efficiency and Minimize Redundancy Session Chair : Pamela Lindroos	Tue, June 25 10:15AM CME, IACET, RN
  The New European Pharmacovigilance Legislation: Guiding Medical Writers Through the Risks and Benefits Session Chair : Julia Cooper	Tue, June 25 1:45PM IACET
  Protocol Trends and Strategies for Quality Session Chair : Linda Fossati Wood	Tue, June 25 4:00PM CME, IACET, RN
  Tethering the Channels of Scientific and Medical Content Session Chair : J. Lynn Bass	Wed, June 26 8:00AM CME, IACET, RN
  Globalization of Medical Communications/Medical Science Liaisons: A Comparison of Guidance and Practice Differences Session Chair : Thomas M. Gesell	Wed, June 26 10:15AM CME, IACET, RN
  Recent Corporate Integrity Agreements: Impact on Industry-sponsored Publications and Medical Communications Activities Session Chair : Monica A. Kwarcinski	Wed, June 26 1:45PM CME, IACET, RN
  Learnings from Safety Communications Across the Industry: Patients and EMA, REMS and FDA, Physicians and Medical Information Groups Session Chair : Stacey M. Fung	Wed, June 26 4:00PM ACPE, CME, IACET, RN
  Key Learnings from the Approval and Launch of a 505(b)(2) Product from a Medical Communications Perspective Session Chair : Tamar S. Yarkoni	Thu, June 27 9:00AM CME, IACET, RN
  Insights into China: Practical Tips for Writing Publication and Regulatory Documents Session Chair : Julie A. Ely	Thu, June 27 10:45AM CME, IACET, RN

Medical Devices, In Vitro Diagnostics, and Combination Products (8)

• Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon Session Chair : Janet Jenkins-Showalter	Mon, June 24 11:00AM CME, IACET, RN
  Postmarket Surveillance Issues for Medical Devices Session Chair : Kirsten H. Paulson	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges Session Chair : Janet Jenkins-Showalter	Tue, June 25 1:45PM CME, IACET, RN
  Diagnostic Biomarker Verification and Validation: A Cost-efficient, Speed to Market Adaptive Design Clinical Trial Model Session Chair : Alan J. Touch	Tue, June 25 4:00PM CME, IACET, RN
  How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k) Session Chair : Michael A. Swit	Wed, June 26 8:00AM ACPE, CME, IACET, RN
  Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics Session Chair : Paul Sheives	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors Session Chair : Kevin B. Johnson	Wed, June 26 4:00PM CME, IACET, RN
  Medical Devices Global Symposium Session Chair : Ekopimo O. Ibia	Thu, June 27 9:00AM CME, IACET, RN

Nonclinical and Translational Development/Early Phase Clinical Development (8)

• Global Symposium Session Chair : Barry Mangum	Mon, June 24 11:00AM CME, IACET, RN
  Translational Aspects from Preclinical Animal Toxicology Studies to Early Human Health Risk Assessment: Needs and Limitations Session Chair : Celine Adessi	Mon, June 24 2:30PM ACPE, CME, IACET, RN
  The Thorough QT Study: Isn’t There a Better Way to Do This? Session Chair : Jay W Mason	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Measuring the Impact of Subject Dual Enrollment on Study Data Validity and a Web-based Tool to Avoid Simultaneous Participation in Multiple Concurrent Clinical Trials Session Chair : Darran Boyer	Tue, June 25 10:15AM CME, IACET, RN
  Human Abuse Liability Testing in CNS Drug Development Session Chair : Lynn Roy Webster	Tue, June 25 1:45PM ACPE, CME, IACET, RN
  Optimizing the Transition from Preclinical to Clinical Research Session Chair : Stella Stergiopoulos	Tue, June 25 4:00PM CME, IACET, RN
  Molecular Imaging: Utilizing It as an Effective Drug Development Tool Session Chair : Todd E. Peterson	Wed, June 26 8:00AM ACPE, CME, IACET, RN
  Pharmacometrics: Implications and Impact in Preclinical to Early Phase Clinical Development Session Chair : Royce A. Morrison	Wed, June 26 10:15AM CME, IACET, RN

Pharmaceutical Quality (11)

• Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets Session Chair : Thirunellai G Venkateshwaran	Mon, June 24 11:00AM CME, IACET, RN
  Update on Submission and GMP Expectations for Part 3 Combination Products Session Chair : Michael Folkendt	Mon, June 24 2:30PM CME, IACET, RN
  Developing and Embracing a Culture of Quality in the Pharmaceutical Industry Session Chair : Mary Oates	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Strategies for the Development and Registration of Antibody Drug Conjugates Session Chair : Sarah C. Pope Miksinski	Tue, June 25 10:15AM ACPE, CME, IACET, RN
  Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot Session Chair : Evdokia Korakianiti	Tue, June 25 4:00PM IACET
  How to Prepare for Meetings, Both Internal and with the FDA Session Chair : Antoinette Paone	Wed, June 26 8:00AM CME, IACET, RN
  Current Developments in the Automated NDA Field Alert Reporting Project Session Chair : Mark W. Browning	Wed, June 26 8:00AM CME, IACET, RN
  Drug Shortages: Causes, Current State and Path Forward Session Chair : Marta E. Wosinska	Wed, June 26 10:15AM ACPE, CME, IACET, RN
  Implementation of Quality by Design: Progress, Challenges and Opportunities - Industry Perspective Session Chair : Moheb M. Nasr	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective Session Chair : Christine M. V. Moore	Wed, June 26 4:00PM ACPE, CME, IACET, RN
  Postapproval Change Management: Challenges and Opportunities Session Chair : Christine M. V. Moore	Thu, June 27 9:00AM CME, IACET, RN

Processes and Technologies for Clinical Research (23)

• Evaluation and Selection of the Optimal Endpoints for Clinical Studies Session Chair : Freda W. Cooner	Mon, June 24 11:00AM ACPE, CME, IACET, RN
  Managing Data at Arms' Length: China Session Chair : Ralph Douglas Harkins	Mon, June 24 11:00AM CME, IACET, RN
  CDISC SHARE: A Promising Approach to Therapeutic Area Standards Development Session Chair : Wayne R. Kubick	Mon, June 24 2:30PM ACPE, CME, IACET, RN
  That Awkward Stage: Transition from Paper Trial Master File to eTMF Session Chair : Denise Derenzo Lacey	Mon, June 24 2:30PM IACET
  Data from Everyone: Using Smartphones and the Internet to Connect with Subjects Session Chair : Anne M. Zielinski	Tue, June 25 8:00AM CME, IACET, RN
  Development of a New Patient-reported Outcome (PRO) Measure for Depression: Progress and Results from the PRO Consortium Session Chair : Stephen Joel Coons	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Changing View of Electronic Data Capture (EDC) and Implications for Data Quality Session Chair : Laurie S. Callen	Tue, June 25 1:45PM CME, IACET, RN
  Innovative Computerized System Validation and Auditing Session Chair : Frances E. Nolan	Tue, June 25 1:45PM CME, IACET, PMI, RN
  Real-world Electronic Health Records Data and Informatics Technology in Drug Development and Life Cycle Management Session Chair : Mitra Rocca	Tue, June 25 4:00PM ACPE, CME, IACET, RN
  Real, Transparent Dialogue from Three Sponsors: Destination eTMF - Are We There Yet? Session Chair : Nancie E. Celini	Tue, June 25 4:00PM CME, IACET, RN
  Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials Session Chair : J. Jason Lundy	Wed, June 26 8:00AM ACPE, CME, IACET, RN
  Enhancing Regulatory Science and Expediting Drug Development: eClinical and eHealth Tools Session Chair : Ron Fitzmartin	Wed, June 26 8:00AM ACPE, CME, IACET, RN
  EDC Insights: Before, During, and After Session Chair : Maryanne C. Nicosia	Wed, June 26 10:15AM CME, IACET, RN
  Advancing Endpoint Adjudication Session Chair : Jonathan Seltzer	Wed, June 26 10:15AM ACPE, CME, IACET, RN
  Cloud Technology for Decision Makers: What’s Real and How to Validate It Session Chair : Teri E. Stokes	Wed, June 26 1:45PM CME, IACET, RN
  Coalition for Accelerating Standards and Therapies (CFAST): The Ultimate Drug Development Drivers Session Chair : Rebecca D. Kush	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Clinical Trial Visit of the Future: Leveraging Emerging Technologies to Crack the Patient Recruitment Challenge Session Chair : Komathi Stem	Wed, June 26 4:00PM CME, IACET, RN
  Data Standards Strategy Session Chair : Stephen E. Wilson	Wed, June 26 4:00PM CME, IACET, PMI, RN
  eDM From Three Sponsors Session Chair : Bhanu Bahl	Thu, June 27 9:00AM IACET
  Changing Landscape of IT in the Pharmaceutical Industry Session Chair : Pamela Campbell	Thu, June 27 9:00AM CME, IACET, RN
  Emerging Electronic Tools in Cardiovascular Outcomes Studies Session Chair : Jonathan Plehn	Thu, June 27 10:45AM CME, IACET, RN
  Implementing a Paperless Trial for Phase 3: A Biotech’s Lessons Learned Session Chair : Mary R. Flack	Thu, June 27 10:45AM CME, IACET, RN
  What's the Point? Can Point of Care Devices Enhance Clinical Trials? Session Chair : Erin Iturriaga	Thu, June 27 10:45AM CME, IACET, RN

Professional Development (14)

• Challenges and Solutions for Professional Development and Training of Clinical/Nonclinical Staff Session Chair : Nancy P. Smerkanich	Mon, June 24 11:00AM CME, IACET, RN
  The Secret of Stellar Careers: Serendipity plus Planning = Success Session Chair : Sandra A Wiejowski	Mon, June 24 2:30PM IACET
  DNA of Entrepreneurs: Calculated Risk-taking and Bringing Game-changing Technology to the World Session Chair : Leslie J Williams	Tue, June 25 8:00AM CME, IACET, RN
  Advanced Presentation Skills Session Chair : Lauren Edelstein Henry	Tue, June 25 10:15AM IACET
  DIA 2013 Student Forum: Getting a Job and Developing a Career Session Chair : Danny A. Benau	Tue, June 25 10:15AM IACET
  So You Want to Foster Innovation: A Neuroscience Primer on How Creative Ideas Arise from the Brain Session Chair : C. Latham Mitchell	Tue, June 25 4:00PM CME, IACET, RN
  Advanced Presentation Skills Session Chair : Lauren Edelstein Henry	Tue, June 25 4:00PM IACET
  How Economic and Technological Change Can Affect Professional Expectations: Case Studies in Succeeding in the Midst of Change Session Chair : Elizabeth Lincoln	Wed, June 26 8:00AM CME, IACET, RN
  Successful Mentoring Relationships Session Chair : Susan Morris	Wed, June 26 10:15AM CME, IACET, RN
  Submitting an Abstract for the DIA 2014 50th Annual Meeting Session Chair : Julie Ho	Wed, June 26 1:45PM IACET
  Transition from Subject Matter Expert (SME) to Subject Matter Educator Extraordinaire (SMEE)! Session Chair : Kristina R Barkhouser	Wed, June 26 1:45PM CME, IACET, RN
  Ensuring Patient-centered Care: Partnering with Patient Advocacy Session Chair : Vicki Breitbart	Wed, June 26 4:00PM ACPE, CME, IACET, RN
  Mobile Learning and Social Media Symposium Session Chair : Pamela Loughner	Thu, June 27 9:00AM CME, IACET, RN
  Cultural Awareness and Collaboration Session Chair : Gary M. Bufferd	Thu, June 27 10:45AM CME, IACET, RN

Project/Portfolio Management and Strategic Planning (19)

• Stage Gate Decision-making Workshop, Part 1 of 2 Session Chair : Courtland R. LaVallee	Mon, June 24 11:00AM CME, IACET, RN
  Portfolio Management Symposium Session Chair : Gregg Schneider	Mon, June 24 11:00AM IACET, PMI
  Stage Gate Decision-making Workshop, Part 2 of 2 Session Chair : Courtland R. LaVallee	Mon, June 24 2:30PM CME, IACET, RN
  Bridging the Gap Between Strategy and Execution Session Chair : Akhil Agrawal	Mon, June 24 2:30PM CME, IACET, PMI, RN
  The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols Session Chair : Anne B. Cropp	Tue, June 25 8:00AM CME, IACET, RN
  Careers Beyond Project and Portfolio Management: A Panel Discussion Session Chair : Leigh Shultz	Tue, June 25 8:00AM IACET, PMI
  Effective Diverse Team Collaboration and Management for Drug Development: Key Commonalities and Differences among Korea, China and Japan Session Chair : Atsushi Tsukamoto	Tue, June 25 10:15AM CME, IACET, RN
  Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions Session Chair : Michael A. Swit	Tue, June 25 1:45PM ACPE, IACET
  Approaches to Quality Risk Management: Understanding What Matters Session Chair : Martin Landray	Tue, June 25 1:45PM CME, IACET, RN
  Strategic Planning of the Global Program to Facilitate Regulatory Approval and Market Access Session Chair : Libbie Mansell	Tue, June 25 4:00PM CME, IACET, RN
  Cost Management for Global Drug Development Projects Session Chair : Mark A. Kryah	Wed, June 26 8:00AM CME, IACET, PMI, RN
  Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development Session Chair : Barbara Leishman	Wed, June 26 8:00AM CME, IACET, RN
  So You Want to Be a Project Manager: How to Find Your Way to a Challenging and Rewarding Career Session Chair : Karla Childers	Wed, June 26 10:15AM IACET
  Challenges and Strategic Approaches to Biosimilar Development Session Chair : Jayanthi Reddy	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Using Competence Models to Drive High Quality Drug Project Management Session Chair : Peter Harpum	Wed, June 26 1:45PM CME, IACET, PMI, RN
  Pharmacometric Methods: Essential for Optimal Drug Development Strategy Session Chair : Royce A. Morrison	Wed, June 26 4:00PM CME, IACET, RN
  Pharmaceutical Project Management: What's Really Important and How Can We Do Better? Session Chair : John Z. Sun	Wed, June 26 4:00PM IACET, PMI
  Orphan Drug Development Strategy by Big and Medium/Small Pharmaceutical Industries Session Chair : Noriaki Murao	Thu, June 27 9:00AM ACPE, CME, IACET, RN
  The Importance of Country Selection in Clinical Study Design Session Chair : Joan M Meyer	Thu, June 27 10:45AM CME, IACET, RN

Public Policy/ Health Care Compliance/ Law (10)

• Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials Session Chair : Mark C. Hegarty	Mon, June 24 11:00AM ACPE, CME, IACET, RN
  Cooperation Among Regulators: Impact on Stakeholders Session Chair : Marie Allison Dray,Murray M. Lumpkin	Mon, June 24 2:30PM ACPE, CME, IACET, RN
  Legal Jeopardy from the Conduct of Clinical Trials Session Chair : Mark C. Hegarty	Mon, June 24 2:30PM ACPE, CME, IACET, RN
  Ethical Issues in Clinical Trials Session Chair : Art Gertel	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Breakthrough Therapy: One Candle on the Birthday Cake - Are Innovators Enjoying Sweet Success or Is the Pathway Not Baked Yet? Session Chair : Nancy Bradish Myers	Tue, June 25 4:00PM ACPE, CME, IACET, RN
  Using Legislation to Advance Regulatory Science: "I'm Just a Bill..." Session Chair : Karen E. Jaffe	Wed, June 26 8:00AM ACPE, CME, IACET, RN
  Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow Session Chair : Barry A. Berger	Wed, June 26 10:15AM ACPE, CME, IACET, RN
  The Science of Compliance Session Chair : Patrick C. O'Brien	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Meeting the Challenges of Health Care Disparities and Clinical Trial Requirements in the Global Environment Session Chair : Florence Houn	Wed, June 26 4:00PM ACPE, CME, IACET, RN
  Ethical Issues in Clinical Trials Session Chair : Art Gertel	Wed, June 26 4:00PM ACPE, CME, IACET, RN

Rare/Orphan Diseases (9)

• Research Advances for Rare Diseases and Orphan Products Session Chair : Peter L. Saltonstall	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  Is There a Recipe for Successful Implementation of Registries for Rare Diseases? Session Chair : Martine Zimmermann	Tue, June 25 1:45PM ACPE, CME, IACET, RN
  Development for Rare Disease Treatments Session Chair : Jurgen Venitz	Tue, June 25 4:00PM CME, IACET, RN
  Movie Documentary: RARE Session Chair : Karen E. Jaffe	Tue, June 25 5:30PM
  Models for Genomic Research Success: Empowering Patient-Researcher Relationships and the Emerging Role of Crowd Sourcing in Rare Disease Research Session Chair : Cheng-Ho Lin	Wed, June 26 8:00AM CME, IACET, RN
  Rising to the Challenge of Developing Novel Orphan Medicines for the Global Market Session Chair : Cecil J. Nick	Wed, June 26 1:45PM CME, IACET, RN
  Rescuing and Repurposing Drugs: Challenges and Opportunities Session Chair : Cindy Luxhoj Hahn	Wed, June 26 4:00PM CME, IACET, RN
  Movie Documentary: Here.Us.Now. Session Chair : Lesa Mitchell	Wed, June 26 5:30PM
  The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value Session Chair : Charles A. Stevens	Thu, June 27 9:00AM CME, IACET, RN

Regulation of Product Advertising and Marketing in an Ever-changing World (4)

• Prescription Drug Marketing Regulatory Primer Session Chair : Janet L. "Lucy" Rose	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  FDA Enforcement Update: Advertising and Promotion Session Chair : Wayne L. Pines	Tue, June 25 10:15AM ACPE, CME, IACET, RN
  Drug Development for Commercial Success Session Chair : Michele L. Sharp	Tue, June 25 1:45PM CME, IACET, RN
  Product Communications in the Preapproval Phase Session Chair : Mark Gaydos	Tue, June 25 4:00PM CME, IACET, RN

Regulatory Affairs and Submissions (24)

• Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators Session Chair : Virginia L. Behr	Mon, June 24 11:00AM CME, IACET, RN
  Pediatric Drug Development: A New Paradigm Under FDASIA Session Chair : Rosemary M. Addy	Mon, June 24 11:00AM ACPE, CME, IACET, RN
  Navigating the Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs) and Combined ATMPs Session Chair : Mark J. Hope	Mon, June 24 2:30PM CME, IACET, RN
  Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy Session Chair : Jeffrey N. Stuart	Mon, June 24 2:30PM CME, IACET, RN
  A Regulatory Perspective of Biosimilars in Emerging Markets Session Chair : Linda F. Bowen	Tue, June 25 8:00AM CME, IACET, RN
  Expediting Drug Development and Review for Serious Conditions Session Chair : Robert J. Temple	Tue, June 25 8:00AM ACPE, CME, IACET, RN
  The Aging Population: Approaches to Ensure Safety and Efficacy Session Chair : Francesca Cerreta	Tue, June 25 10:15AM ACPE, CME, IACET, RN
  US and EU Regulatory Update of Clinical Trial Disclosure Session Chair : Barbara Godlew	Tue, June 25 1:45PM CME, IACET, RN
  Electronic Submissions in PDUFA V Session Chair : Nancy D. Smith	Tue, June 25 1:45PM CME, IACET, RN
  Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This? Session Chair : Stuart Walker	Tue, June 25 1:45PM CME, IACET, RN
  Labeling and Patient Medical Information (PMI) Session Chair : Lynette Hopkinson	Tue, June 25 4:00PM ACPE, CME, IACET, RN
  Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access Session Chair : Charles A. Stevens	Tue, June 25 4:00PM CME, IACET, RN
  Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions Session Chair : Janel Demeter	Wed, June 26 8:00AM IACET
  FDASIA: Impact of New Legislative Provisions on Innovative Drug Development Session Chair : Janet Jenkins-Showalter	Wed, June 26 8:00AM CME, IACET, RN
  Advancing Alzheimer’s Innovation: A Call to Action Session Chair : Meryl Comer	Wed, June 26 10:15AM ACPE, CME, IACET, RN
  A Comparison of Study Startup Regulations and Timelines in Several Major Emerging Markets and the Decision Process for Selection Session Chair : David Passov	Wed, June 26 10:15AM CME, IACET, RN
  FDASIA Patient Provisions: One Year Later Session Chair : James E. Valentine	Wed, June 26 1:45PM CME, IACET, RN
  eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation Session Chair : Daniel F. Orfe	Wed, June 26 1:45PM IACET
  Advancing Alzheimer's Innovation: Patient Advocacy, Caregiver Support and Health Care System Impact Session Chair : Robert Feeney	Wed, June 26 1:45PM ACPE, CME, IACET, RN
  Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges Session Chair : Andrew Satlin	Wed, June 26 4:00PM ACPE, CME, IACET, RN
  Global Pediatric Development: Next Steps Session Chair : Chin Koerner	Wed, June 26 4:00PM CME, IACET, RN
  Electronic Regulatory Submission (ERS) Development and the Impact on the Sponsor’s Organization: Retooling R&D for ERS Session Chair : Peter M. Lassoff	Wed, June 26 4:00PM CME, IACET, RN
  NDA Submission Strategy for New Chemical Entity (NCE) Products in Asia Pacific Countries to Reduce Drug Lag Session Chair : Shun Jin	Thu, June 27 9:00AM CME, IACET, RN
  Certificate of Pharmaceutical Product (CPPs): How Can the Process for Obtaining from and Submitting to Health Authorities Be Made More Efficient? Moving from Ribbons and Wax to Electronic Solutions Session Chair : Fraser McKillop Stodart	Thu, June 27 10:45AM CME, IACET, RN

Statistical Science and Quantitative Thinking (11)

• Hot Topics in Statistics: Working Together Effectively to Transform Our Science Session Chair : Stephen E. Wilson	Mon, June 24 11:00AM CME, IACET, RN
  Key Multiplicity Issues in Clinical Trials Session Chair : Alex Dmitrienko	Mon, June 24 2:30PM CME, IACET, RN
  Biomarkers for Drug Development: How Are We Dealing with the Challenges? Session Chair : Sue-Jane Wang	Tue, June 25 8:00AM CME, IACET, RN
  Statistical Considerations When Developing Antibacterial Treatments Session Chair : Rima Izem	Tue, June 25 10:15AM CME, IACET, RN
  Looking Closer into the Utility of Adaptive Approaches Session Chair : Sue-Jane Wang	Tue, June 25 1:45PM CME, IACET, RN
  Analysis Data Standards: Developing, Applying, Submitting and Reviewing Session Chair : Stephen E. Wilson	Tue, June 25 4:00PM CME, IACET, RN
  Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians Session Chair : Susan P. Duke	Wed, June 26 8:00AM CME, IACET, RN
  Clinical Trial Simulations and Modeling Session Chair : David A. Amato	Wed, June 26 1:45PM CME, IACET, RN
  Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives Session Chair : Surya P. Chitra	Wed, June 26 4:00PM CME, IACET, RN
  Some Innovative Approaches to Handling Missing Data Problems in Clinical Trials Session Chair : Peiling Yang	Thu, June 27 9:00AM CME, IACET, RN
  Bayesian Methods in Medical Product Development and Comparative Effectiveness Session Chair : David Ohlssen	Thu, June 27 10:45AM ACPE, CME, IACET, RN

White Paper Showcase (5)

• Next Generation Medical Information Call Center Session Chair : Chip Kalfaian	Mon, June 24 11:00AM
  Moving to a Standards-based, Agile Clinical Development Lifecycle Session Chair : Julie Smiley	Tue, June 25 8:00AM
  Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology Session Chair : Kenneth J. Pennline	Tue, June 25 10:15AM
  Learning to Share-Sharing To Learn: How an Industry Learns to Honor Its Volunteers Session Chair : Matt Gross	Tue, June 25 1:45PM
  Four Ways to Accelerate Clinical Portfolio Strategy Session Chair : Larissa Comis-Tis	Tue, June 25 4:00PM