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Title Event Type Day Time Track(s) Credits
#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
#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
#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
#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
#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
#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
#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
#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
#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
#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
#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
#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
#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
#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
#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
#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