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Title Event Type Day Time Track(s) Credits
Plenary Session & Keynote Address Forum Monday, Jun 16 2:30PM - 4:00PM (Pacific Standard Time) Opening Plenary - Keynote Address
Bringing the Patient Voice to Clinical Development Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Does One Size Fit All? Understanding the Impact of Cultural Differences Across the Globe Workshop Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Global Clinical Trials Symposium: Opportunities and Challenges Symposium Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Engaging Patients through Digital and Social Media Communities Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Monitor Training: Building Essential Skills for Implementing Risk-Based Monitoring - Data Interpretation, Quality by Design Workshop Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Updated Strategies for Effective Recruitment of Patients in Clinical Trials Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Improving the Informed Consent Process Symposium Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Risk-Based Monitoring: From Concept to Practice Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Social Listening as a Tool to Inform Study Teams on Social Media Strategy for Recruitment and Building Patient-Centric Trials Forum Tuesday, Jun 17 10:30AM - 11:30AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Improving Investigative Site Selection Practices Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Optimization of and Enhancements to Interactive Response Technology to Ensure Efficient Investigational Product and Study Material Management Symposium Tuesday, Jun 17 1:30PM - 2:30PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Building a Site Budget from the Ground Floor Workshop Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Patient Registries: Designing, Implementing, and Leveraging to Accelerate Clinical Trials Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Perfecting the Protocol: Designing Studies for Success Symposium Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Metrics Benchmarking, Predictive Analytics, and Virtual Population Simulation: New Tools to Contextualize and Forecast Trial Performance Symposium Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
The Sites Have Spoken: Implementing Paperless Trials and Risk-Based Monitoring from a Site’s Perspective Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Clinical Supply Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Risk-Based Monitoring Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Site Selection and Feasibility Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Hot Topics in Patient Recruitment: Global Demographics, Underrepresented Populations, and the Science Behind Patient Communications Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Social Media in Patient Recruitment: How to Best Leverage the Digital Ecosystem Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Filling the Gaps and Speeding Up Results: What an Educated, Sophisticated Patient Population Can Do for You Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Optimize Protocol Design: A Path to Efficient, Lower Cost Trial Execution Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Accelerating Research in a Large Health Care System: Streamlining Research Review and Study Initiation Workshop Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
#30: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation Tutorial Sunday, Jun 15 1:00PM - 4:30PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 07 - Processes and Technologies for Clinical Research;Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 10 - Public Policy/Health Care Compliance/Law;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 12 - Pharmaceutical Quality;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 14 - Clinical Safety and Pharmacovigilance;Track 15 - Statistical Science and Quantitative Thinking;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases IACET
#23: Leadership: How to Organize and Lead People in Group Work Tutorial Sunday, Jun 15 8:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 07 - Processes and Technologies for Clinical Research;Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 10 - Public Policy/Health Care Compliance/Law;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 12 - Pharmaceutical Quality;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 14 - Clinical Safety and Pharmacovigilance;Track 15 - Statistical Science and Quantitative Thinking;Track 16 - Professional Development;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases IACET, PMI
The Twitter Value Proposition for Life Science Professionals Workshop Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 07 - Processes and Technologies for Clinical Research;Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 10 - Public Policy/Health Care Compliance/Law;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 12 - Pharmaceutical Quality;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 14 - Clinical Safety and Pharmacovigilance;Track 15 - Statistical Science and Quantitative Thinking;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Managing Innovation: Challenges and Opportunities Today and for the Future Workshop Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 07 - Processes and Technologies for Clinical Research;Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 10 - Public Policy/Health Care Compliance/Law;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 12 - Pharmaceutical Quality;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 14 - Clinical Safety and Pharmacovigilance;Track 15 - Statistical Science and Quantitative Thinking;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases CME, IACET, RN
Abstract and Article Publication Opportunities with DIA Workshop Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 07 - Processes and Technologies for Clinical Research;Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 10 - Public Policy/Health Care Compliance/Law;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 12 - Pharmaceutical Quality;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 14 - Clinical Safety and Pharmacovigilance;Track 15 - Statistical Science and Quantitative Thinking;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases IACET
The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances, and Precision Medicine (Part 2 of 2) Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 19 - Executive Program CME, IACET, RN
The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances, and Precision Medicine (Part 1 of 2) Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 19 - Executive Program;Track 19 - Executive Program CME, IACET, RN
#31: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges and Decision Criteria Tutorial Sunday, Jun 15 1:00PM - 4:30PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions IACET
#32: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine Tutorial Sunday, Jun 15 1:00PM - 4:30PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products ACPE, CME, IACET, RN
Pioneering Regenerative Medicine: Trends in Regulations for New Therapy Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Organs on a Chip: The Future of Efficacy and Safety Testing Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 14 - Clinical Safety and Pharmacovigilance;Track 20 - Late-breaking Topics CME, IACET, RN
#24: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing Tutorial Sunday, Jun 15 8:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions IACET
#21: The Sunshine Act: Understanding the Essentials of Compliance Tutorial Sunday, Jun 15 8:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Improving Communication in the Informed Consent Process: The Advantages of eConsent Workshop Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Digital Health: Mobile Medical Apps and the Future of Health Care Delivery Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 07 - Processes and Technologies for Clinical Research;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Enabling Participants' Access to the Electronic Clinical Trial Data: The Blue Button Project Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 07 - Processes and Technologies for Clinical Research;Track 20 - Late-breaking Topics ACPE, CME, IACET, RN
#22: Preparing for a US FDA Advisory Committee Meeting Tutorial Sunday, Jun 15 8:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions IACET
From the Protocol to the Patient: Clinical Trial Data Disclosure Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products ACPE, CME, IACET, RN
#46: The Good Pharmacovigilance Practices In The EU: Lessons Learned and Frequently Asked Implementation Questions Tutorial Sunday, Jun 15 9:00AM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
#35: Understanding Translational Medicine: Benefits and Innovative Approaches Tutorial Sunday, Jun 15 1:00PM - 4:30PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development CME, IACET, RN
#41: Quality Oversight of CROs-Clinical Vendors Tutorial Sunday, Jun 15 9:00AM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice IACET
Research Site Quality Compliance Programs: Review of Industry Gold Standards Workshop Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
SAS/JMP Innovation Theater: Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP Clinical Special Session Wednesday, Jun 18 11:45AM - 12:15PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 21 - Innovation Theater
#43: Clinical Statistics for Nonstatisticians Tutorial Sunday, Jun 15 9:00AM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
#44: Quality by Design: From Theory to Practice Tutorial Sunday, Jun 15 9:00AM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Parents as Partners: Overcoming Unique Challenges to Pediatric Recruitment and Retention Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 17 - Rare/Orphan Diseases CME, IACET, RN
Collaboration in R&D: What’s New for TransCelerate BioPharma? Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 19 - Executive Program ACPE, CME, IACET, RN
Making Better Go/No-Go Decisions: Improving Success Rates and Reducing Costs Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Stage Gate Decision-Making Workshop (Part 1 of 2) Workshop Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Improving Returns on Invested Capital in the Pharmaceutical and Biotechnology Industry Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Stage Gate Decision-Making Workshop (Part 2 of 2) Workshop Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Drug Development and the Virtual Company Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Effective Leadership in Hybrid Team Between West and East Asia in New Drug Development Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
National Strategy to Bridge the Gap Between Academic Innovation and Commercialization in Asia Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Challenges and Strategic Approaches to Development of a Novel Biologic Versus a Biosimilar Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Virtual Teams in Clinical Development Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Development of Central Nervous System Drugs with Abuse Potential Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning ACPE, CME, IACET, RN
Life Cycle Management of Biopharmaceuticals: An Approach and Lessons Learned for an Imperative Business Practice Session Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Why Does Drug Development Need Project Management? Session Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Career Planning and Limitations for Mid- to Upper-Level Project Managers Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Project Management Basics: Creating a High-Level Project Plan Workshop Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Complex Drug Projects: Complex Project Management Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Project Management Plays Critical Roles in the New Challenging Environment Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Exploring Responder-Patient Clinical Study Design Approaches Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning ACPE, CME, IACET, RN
A Hitchhiker's Guide to Working with Management Consultants Workshop Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Managing Global Teams: Navigating Through Cultural, Lingual, and Geographic Challenges Session Wednesday, Jun 18 1:30PM - 2:30PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development CME, IACET, PMI, RN
Beyond Operational Excellence: A Survey on Sponsor Expectations of Preferred Business Partners Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
R&D and Technology Outsourcing Today: An Industry Update Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Risk Sharing or Risk Transfer? Striking the Perfect Balance in Strategic Partnerships Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Big Data, Big Impact: New Levels of Strategic Partnerships Between Sponsors-CROs Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
The State of Clinical Outsourcing: Do Outsourcing Partnerships Promote or Impede Progress Toward Clinical Trial Optimization? Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
How a New Collaboration Between a Biopharmaceutical Company and a CRO Is Improving the Quality, Speed, and Efficiency of Drug Development Forum Tuesday, Jun 17 3:30PM - 4:30PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies ACPE, CME, IACET, RN
Achieving Success in a Mega-Trial Sponsor/ARO/CRO Collaboration: Approaches to Overcome Challenges and Optimize Results Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Optimizing Outsourcing Relationships: Data-Driven Strategies to Support Vendor Selection, Negotiation, and Management Symposium Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
The Present and Future of Pharmaceutical Development Outsourcing: Where Are We Today and Where Are We Going? Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Vendor Selection for a Small Company Forum Wednesday, Jun 18 10:30AM - 11:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Costing Strategies for Sustainable Drug Development Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Functional Service Provider Relationships: Critical Factors to Ensuring Long-Term Success Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Effective Strategic Partnering Between Small Pharmaceutical Companies and CROs: Discussion and Case Study Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
The Sponsor-Vendor-Vendor Relationship: A Fine Balance Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Keeping It Together: Syncing CRO Data and Metrics Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
The Evolution of Strategic Partnerships and the Four P's of International Relationship Building Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn't) Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 19 - Executive Program CME, IACET, RN
Proarrhythmic Risk Assessment WITHOUT the Thorough QT: FDA and Pharmaceutical Company Perspectives Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Nanotechnology: Application to Medical Products Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development ACPE, CME, IACET, RN
Juvenile Animal Studies and Pediatric Nonclinical Development Session Tuesday, Jun 17 10:30AM - 11:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Gene Therapy Symposium Symposium Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Designing Smarter and More Cost-Effective Phase 1 Protocols Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Site Certification of Early Phase Research Units: An International Perspective Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Phase 1 Studies in Renal and Hepatic Subjects: Considerations and Best Practices in Design and Conduct Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Predicting Drug Off-Target Protein Binding to Hypothesize Mechanisms for Safety Issues Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Bioinformatics and Translational Medicine Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
#42: Regulatory Affairs for Biologics Tutorial Sunday, Jun 15 9:00AM - 5:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions IACET
Trends in Biosimilars Regulation Within Developed and Emerging Markets Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
FDA Regulation of Therapeutic Products Derived from Human Stem Cells: Successfully Navigating the Regulatory Hurdles Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Safety in Special Situations: Stem Cells, Vaccines, and Combination Products Symposium Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Prescription Drug Marketing Regulatory Primer Workshop Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
FDA Enforcement Update: Advertising and Promotion Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
International Regulatory Advertising and Promotion Considerations Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Understanding Corporate Integrity Agreements/Trends: What Can We Expect and Why Is It Important? Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Industry in the Sunshine: How the “Sunshine” Provisions of the Affordable Care Act Will Change Industry Policy and Practice Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
FDA Drug Claims Substantiation after IMS and Caronia: Will Court Scrutiny Based on the First Amendment Lead to Change in Current Policy and Practice? Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Delivering Value Through Medical Content to Health Care Providers Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Communicating Clinical Trial Results: Targeting the Patient Audience Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Preparing for a Successful Product Launch Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
In-Sourcing, Out-Sourcing: Where Do We Go from Here? Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Promotional Material Management: From Review to Submission – Contemporary Ideas Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Our First Year Under Sunshine: Impact on Medical and Scientific Communications Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
The Regulatory Writing Game Show Workshop Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Professional Career Development Within Medical Affairs: A Perspective from Medical Communications, Medical Science Liaisons, and Medical Writers Session Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Field-Based Medical Communications on a Global Scale Session Wednesday, Jun 18 10:30AM - 11:30AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Broadening Health Care Communications: Learnings from Health Authority Initiatives Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Powering Up Communications: Improving the Information Exchange Between Patients and Industry Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Transforming Organizational Knowledge into Product Information: Can Structured Authoring Save the Day? Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Today's Dynamic Medical Science Liaison Environment Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Regulatory Submissions: Better, Faster, and Cheaper Symposium Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Update on Postmarketing Safety Reporting Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Data Warehousing and Integration: Current Status, Key Success Ingredients and Alternative Approaches for Maximizing the Value of Your Data Symposium Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Driving Toward Standardization: Overcoming Barriers - eDM, eTMF, and CTMS Symposium Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Electronic Clinical Outcome Assessments: Coming to a Device Near You! Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Why Waste Time and Money? Data Standards from the Beginning: Working Together for Good Science and Good Submissions Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Clinical Outcomes Assessment and Patient Engagement Symposium Symposium Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Electronic Source Data in Clinical Investigations (Part 1 of 2): Regulatory Considerations Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Electronic Source Data in Clinical Investigations (Part 2 of 2): Practical Implementation Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Computer System Validation in the Cloud: Cloud Is Here Today and Here to Stay Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Embracing Change: The New Face of Clinical Data Management Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Electronic Standardized Study Data: Regulatory Considerations Forum Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Transforming Culture and Mindsets to Deliver a Higher Quality eTMF Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
CDISC BRIDG Implementation: A Model for System Interoperability and as a Data Base Model Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Clinical Trials Technology Implementation: Bringing Together Patient- and Site-Centric Approaches Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Maximizing the Potential of Your EDC System Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Innovative Direct-to-Patient Study Model to Capture PRO Instrument Validation Data for Submission to a Regulatory Authority Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
End-to-End Data and Metadata in Today's Clinical Trials Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Sustainable Solutions for Global Clinical Research Site Documentation Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Qualifying a Software Vendor in a Regulated Industry Session Thursday, Jun 19 9:00AM - 10:00AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Risk-Based Monitoring: Where We Are and Where We Are Headed Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
A Cloud-Based Approach to Evaluating and Maintaining Global Regulatory Content Alignment Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research;Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Central Statistical Monitoring Revealed: How to Enhance Data Quality and 'De-Risk' Studies Through Enhanced Risk-Based Monitoring Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research;Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Global Pediatric Development: We Are Making Progress Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Fact or Fiction: Patient Engagement in the Drug Development Process Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
PDUFA V New Molecular Entity Program: History, Implementation and Future of the Program Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Regulated Product Submissions and eCTD 4: The Path to Progress Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
The Regulatory Intelligence Function: Evolution Over the Past Decade in an Expanded Global Marketplace Session Tuesday, Jun 17 8:00AM - 9:00AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Efficient Distribution of Information Across Documents to Support Product's Benefit-Risk Ratio for Patients Worldwide Workshop Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
FDA Programs to Encourage Innovation: Maximizing the Opportunities and Confronting the Challenges of New Product Development Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Breakthrough Therapy Designation: One Year After Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
How to Make a Successful Electronic Registration and Listing Submission: NDC, Regulatory Compliance, and Technical Requirements Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Prequalification of Medicines for Neglected Tropical Diseases Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in the Global Regulatory Process Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Utilizing 505(b)(2) to Accelerate Drug Development Plans Session Tuesday, Jun 17 3:30PM - 4:30PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Proprietary Name Review: International Perspectives from the FDA, Health Canada, and EMA Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Regulatory Strategic Plan: Don’t Start Development Without One Workshop Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Implementation of GDUFA: Progress and Expectations Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Adaptive, Progressive or Risk-Based Licensing Models: What Approaches Could Be Considered by Mature and Emerging Markets? Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Benefit-Risk Assessments of Medicines: Framework Development and Use in Marketing Applications Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Health Authority Meeting Preparation: There Are No Do-Overs Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
The Realities of Late Life Cycle Management for Very Old Legacy Brands Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Why, When, and How Should Patients Be Involved in the Benefit-Risk Assessment of Medicines? Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Ethnic Difference in Clinical Trial Data: A 15-Year History of an Investigation by Regulatory Agencies and Industry Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Hot Topics in Medical Devices Labeling: US and Global Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Pediatric Drug Development: Lessons Learned During FDASIA Implementation Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Making Comments Count: Best Practices in Developing Comments for a Global Audience Workshop Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development Tutorial Sunday, Jun 15 8:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics IACET
FDA - Health Canada Regulatory Cooperation Council (RCC) Town Hall Forum Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 18 - Global Regulatory CME, IACET, RN
An International Approach to Benefit-Risk Assessment of Medicines: An Evaluation by a Consortium of Established Agencies Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 18 - Global Regulatory CME, IACET, RN
One Paddle for Two Boats? Policy Alternatives to Buoy Adoption of Precision Therapies and Their Companion Diagnostics Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Device and Diagnostic Innovation Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Dare to Be Different: Comparing Biosensor Data to Patient-Reported Outcomes Data - Learnings from Asthma Session Tuesday, Jun 17 1:30PM - 2:30PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Changing Global Regulatory Climates: Effects on Companion Diagnostics and Combination Products Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Combination Products: An Overview of Clinical Benefits, Regulatory Issues, and Manufacturing Challenges Workshop Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Medical Device Update: Unique Device Identification Rule, Medical Device Reporting Draft Guidance, and Postmarketing Clinical Research Reporting Requirements Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Regulatory Perspectives in the Execution of Clinical Studies and Medical Product Commercialization in Asia Pacific Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports Tutorial Sunday, Jun 15 1:00PM - 4:30PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
CDRH Town Hall Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 18 - Global Regulatory CME, IACET, RN
Formal Dispute Resolution at CDER: When, Why, and How Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Health Care's Revolutionary Printing Press? 3D Printing - Blue Sky and Regulatory Path Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
The Legal, Ethical, and Commercial Issues Impacting the Development and Accessibility of Pediatric Medicines Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Approaches to Decrease the Time Gap Between FDA Approval and the Ability to Market a DEA Scheduled Drug Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Strengthening Public Policy for Sustainable Clinical Research Enterprise in Africa, Asia, and South America: Progress and Prospects Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
EU Clinical Trial Data Transparency Debate: Where Are We? Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Patient Voice in Decision Making: How Are Regulators Making This Work? Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Protocol Deviations: Finding the Yellow Brick Road (Part 1 of 2) Workshop Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Defining, Measuring, and Assessing "Fit for Purpose" Quality in a Risk-Based Monitoring Model: Industry and Agency Perspectives Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Protocol Deviations: Finding the Yellow Brick Road (Part 2 of 2) Workshop Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Quality and Risk Management in an Increasingly Complex Clinical Research Environment: State of the Industry and Leading Practices Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Regulatory and GCP Quality Trends in Emerging Markets Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
GCP Inspection Findings: A Roundtable Discussion Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Adapting GCPs to Evolving Drug Development Paradigm (Part 1 of 2) Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
EMA-FDA GCP Initiative: Current Status and Future Perspectives Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Adapting GCPs to Evolving Drug Development Paradigm (Part 2 of 2) Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice ACPE, CME, IACET, RN
Misconduct and Management of Serious or Continued Noncompliance: Differences, Similarities, and Building a World-Class Program Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
GCP Audits in a Risk-Based Environment Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 1 of 2) Workshop Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 2 of 2) Workshop Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
GCP Quality Agreements Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Bringing Quality to Quality Metrics Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Implementation of Quality by Design: Progress Update Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
CMC Development of Breakthrough Therapies Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Manufacturing Challenges for Breakthrough Products Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Lessons Learned in the Development and Registration of Fixed-Dose Combination Products: CMC Focus Forum Tuesday, Jun 17 3:30PM - 4:30PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Balancing Manufacturing Quality Improvements and Drug Shortage Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality ACPE, CME, IACET, RN
ICH Update: Emerging Guidelines Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Update from the FDA-EMA Parallel Assessment Pilot Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, PMI, RN
Recent Advancement of the Pharmaceutical Inspection Cooperation Scheme and Good Manufacturing Practices in the Asia Pacific Region Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
CMC Regulatory Pathways in the Emerging Markets: Focus on Asia Pacific Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Question-Based Review (QbR): A Risk-Based, Standardized Pharmaceutical Quality Assessment Tool Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, PMI, RN
Introducing CDER's Office of Pharmaceutical Quality Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality;Track 18 - Global Regulatory CME, IACET, PMI, RN
Transforming ICH Toward Greater Global Harmonization Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality;Track 18 - Global Regulatory CME, IACET, RN
A Common Decision Framework for Health Technology Assessment and Regulatory Agencies: Is This of Benefit to Stakeholders? Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
Observational Studies of Comparative Effectiveness: How to Recognize Good Practice Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Using Comparative Effectiveness Research to Make Health Care Decisions: Exploring the Environment, Opportunities, and Challenges Through Real-World Examples Session Tuesday, Jun 17 8:00AM - 9:00AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
Unraveling Evidence-Based Medicine: A Scientific, Ethical, and Socio-Political Analysis Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Assessing Comparative Effectiveness Research Feasibility and Interpretability A Priori Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Leveraging Electronic Health Record Data to Understand Clinical Nuance in Complex Real-World Populations: A Case Study Forum Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Public-Private Partnerships: An Innovative Strategy for Patient Registries Workshop Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Nesting Studies Within Patient Registries to Support Comparative Effectiveness Research Workshop Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Universal Health Coverage and Health Technology Assessment in Emerging Asia Pacific Countries Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
How Can Studies that Inform Relative Effectiveness Best Be Incorporated into Global Drug Development Plans? Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
#33: Bayesian Evidence Synthesis and Network Meta-analysis Tutorial Sunday, Jun 15 1:00PM - 4:30PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Pricing, Economics, Reimbursement, Market Share (PERMS) Strategy: An Interactive Holistic Approach in Rare Diseases Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 17 - Rare/Orphan Diseases CME, IACET, RN
#45: Risk Management Plan Tutorial Sunday, Jun 15 9:00AM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Risk Management in the US, EU, and Asia: Where Are We Now? Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Assessment of Impact and Effectiveness of Risk Management and Minimization in the EU and US Symposium Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Effective Communication Model Between Drug Safety, Regulatory Affairs, and Clinical Development Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Benefit-Risk Throughout the Product Life Cycle: How Should Benefit-Risk Be Evaluated and Communicated from Development through Marketing as New Information Emerges? Symposium Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
EMA-FDA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
How Do We Keep Kids Safe? Pediatric Safety Monitoring From Beginning to End Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Who’s Moving the PV Cheese? Three Game Changing Topics - Impact of Emerging New Requirements for E2B (R3), ICSR Quality Standards, and Benefit-Risk Management Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Evaluating Potential Contribution of Social Media to Postmarketing Medication Safety Surveillance Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
The Pharmacovigilance System Master File: Business as Usual? Can This File Help Industry? Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Signal Detection: Challenges and Strategic Aspects Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
The Challenges of High Quality Risk Management with Single Shared System REMS and Physician Knowledge Surveys Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Expanding the Scope: Empowering the Public in Pharmacovigilance Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Prediction of Safety: An Evolving Field for Selecting Low-Risk Compounds Towards an Effective Life Cycle of a Product Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Natalizumab and Progressive Multifocal Leukoencephalopathy: A Risk Management Case Study Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
The Role of Intelligent Signaling in Digital Disease Detection and Proactive Pharmacovigilance Session Wednesday, Jun 18 1:30PM - 2:30PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Compliance, Potential Financial Implications, and Impact of New Safety Measures Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Product Crisis Management: Crisis, What Crisis? Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
#40: Analysis of Safety Data from Clinical Trials Tutorial Sunday, Jun 15 9:00AM - 5:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Design and Sample Size Planning for Multiregional Clinical Trials Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Strategic Quantitative Thinking: Designing a Roadmap for Innovation Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Mitigating Missing Data in Clinical Trials: Moving Toward Global Behavioral Change Impacts Efficacy, Safety, and Quality Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Impact of Bayesian Methods in Drug Development with a Focus on Comparative Effectiveness Research Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Predictive Enrichment: Design, Development Strategies, and Methodological Issues Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Key Subgroup Analysis Issues in Clinical Trials Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Seeing Is Believing! Good Graphic Design Principles for Medical Research Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Your Future Success as a Master’s Level Statistician: Learn from the Past of These Industry Masters Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking IACET
Separating Perceptions from Reality in the Acceptance of Adaptive Trials by Regulatory Agencies Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Benefit-Risk Evaluation in Drug Development Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Pediatric Trials: Improvements through Bayesian Methods, Adaptive Designs, and Modeling/Simulation Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Exploring Bayesian Approaches Applied to New Treatments for Rare Diseases Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking;Track 17 - Rare/Orphan Diseases CME, IACET, RN
DIA 2014 Student Forum: Maintaining Your Career - Continuing Education and Changing Your Track Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Narrative Medicine: How to Tap into the Inherent Power of Words and Stories in the Clinical Trial Process Workshop Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, RN
Capital Efficient Drug Development with Revolutionary Technologies: Calculated Risks Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, PMI, RN
Networking: It's Not What You Know, But Who You Know! Workshop Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, RN
Yes and ... Applying Improvisational Skills to Improve Innovation Workshop Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, RN
Innovative Engagement Strategies to Inspire Higher Level Commitment and Performance Workshop Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Be a Change Agent: Leveraging Communication and Training Tools to Help Promote Project and Career Transformation Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, PMI, RN
Women as Transformational Leaders Workshop Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Independent Consultant or Permanent Role: Get the Position You Want (Tips from Insiders) Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Walking the Tightrope of Talent Acquisition and Retention: The Balancing Act for Maintaining Productivity, Efficiency, and Quality Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, PMI, RN
Industry Trends, Successes, and Failures in Orphan and Rare Disease Therapeutics Forum Tuesday, Jun 17 10:30AM - 11:30AM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Orphan Drugs and Treatment of Rare Diseases in Asia Symposium Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
International Cooperation in Rare Disease Research Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Optimizing Orphan Drug Development and Using Appropriate Methodology: Key Tips for Success Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Regulatory Challenges for Orphan Medicines Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Innovative Patient Recruitment Solutions for Rare Disease Clinical Trials Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
New Approaches to International Collaboration Between Regulators (Part 1 of 2) Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Development of an Integrated Orphan Drug Framework in Canada Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Europe Town Hall Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Asia Town Hall Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Challenges and Opportunities Facing FDA’s International Posts Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
CDER Town Hall (Part 1 of 2) Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 18 - Global Regulatory ACPE, CME, IACET, RN
CDER Town Hall (Part 2 of 2) Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 18 - Global Regulatory ACPE, CME, IACET, RN
New Approaches to International Collaboration Between Regulators (Part 2 of 2) Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 18 - Global Regulatory;Track 19 - Executive Program CME, IACET, RN
Covering Industry Trends in the Biomedical Industry Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 20 - Late-breaking Topics IACET
Power Up! Give Your Brain a Vacation Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 20 - Late-breaking Topics
The Patient Point-of-View: An Unrehearsed but Revealing Conversation to Rectify Patient Enrollment Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 20 - Late-breaking Topics ACPE, CME, IACET, RN
Informed Medication Use in Pregnancy: A Collaborative Approach to Address Needs for Data, Communication, and Engagement Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 20 - Late-breaking Topics ACPE, CME, IACET, RN
INC Research Innovation Theater: “Organizing for Change”… Lessons Learned in Preparing a Global Organization for Innovation Special Session Monday, Jun 16 1:00PM - 2:00PM (Pacific Standard Time) Track 21 - Innovation Theater
ConvergeHEALTH by Deloitte Innovation Theater: Personalized Medicine Studies and Real-World Analytics for Oncology: M2Gen and ConvergeHEALTH Collaboration Special Session Tuesday, Jun 17 9:45AM - 10:15AM (Pacific Standard Time) Track 21 - Innovation Theater
Covance Innovation Theater: Risk-Based Monitoring - Seeing the Forest for the Trees When Designing and Deploying an Enterprise Process Special Session Tuesday, Jun 17 11:45AM - 12:30PM (Pacific Standard Time) Track 21 - Innovation Theater
Veeva Innovation Theater: Industry’s Largest eTMF Survey: Benchmarks and Insights Special Session Tuesday, Jun 17 12:45PM - 1:15PM (Pacific Standard Time) Track 21 - Innovation Theater
BBK Worldwide Innovation Theater: Adopting New Strategies for the New Face of Patient Recruitment Special Session Tuesday, Jun 17 2:45PM - 3:15PM (Pacific Standard Time) Track 21 - Innovation Theater
Appirio Innovation Theater: The Big R&D Leap: Accelerating Pharmaceutical Innovation and Discovery Through Crowdsourcing Special Session Wednesday, Jun 18 9:45AM - 10:15AM (Pacific Standard Time) Track 21 - Innovation Theater
SAS Innovation Theater: Data Transparency and Sharing: Research Benefits, Risks and the Future Special Session Wednesday, Jun 18 12:30PM - 1:15PM (Pacific Standard Time) Track 21 - Innovation Theater