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Tutorials 

Register Title Date Time Credits Track(s)
#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development Sun, June 15 8:30AM - 12:00PM (Pacific Standard Time) IACET Track 08 - Regulatory Affairs and Submissions;Track 08 - Regulatory Affairs and Submissions;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics
#21: The Sunshine Act: Understanding the Essentials of Compliance Sun, June 15 8:30AM - 12:00PM (Pacific Standard Time) CME, IACET, RN Track 01 - Clinical Operations;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 10 - Public Policy/Health Care Compliance/Law
#22: Preparing for a US FDA Advisory Committee Meeting Sun, June 15 8:30AM - 12:00PM (Pacific Standard Time) IACET Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions;Track 08 - Regulatory Affairs and Submissions
#23: Leadership: How to Organize and Lead People in Group Work Sun, June 15 8:30AM - 12:00PM (Pacific Standard Time) IACET, PMI 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
#24: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing Sun, June 15 8:30AM - 12:00PM (Pacific Standard Time) IACET Track 01 - Clinical Operations;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions
#30: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation Sun, June 15 1:00PM - 4:30PM (Pacific Standard Time) IACET 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
#31: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges and Decision Criteria Sun, June 15 1:00PM - 4:30PM (Pacific Standard Time) IACET Track 01 - Clinical Operations;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions
#32: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine Sun, June 15 1:00PM - 4:30PM (Pacific Standard Time) ACPE, CME, IACET, RN Track 01 - Clinical Operations;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
#33: Bayesian Evidence Synthesis and Network Meta-analysis Sun, June 15 1:00PM - 4:30PM (Pacific Standard Time) CME, IACET, RN Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 15 - Statistical Science and Quantitative Thinking;Track 15 - Statistical Science and Quantitative Thinking
#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports Sun, June 15 1:00PM - 4:30PM (Pacific Standard Time) ACPE, CME, IACET, RN Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 14 - Clinical Safety and Pharmacovigilance
#35: Understanding Translational Medicine: Benefits and Innovative Approaches Sun, June 15 1:00PM - 4:30PM (Pacific Standard Time) CME, IACET, RN Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development
#40: Analysis of Safety Data from Clinical Trials Sun, June 15 9:00AM - 5:00PM (Pacific Standard Time) ACPE, CME, IACET, RN Track 15 - Statistical Science and Quantitative Thinking;Track 15 - Statistical Science and Quantitative Thinking;Track 15 - Statistical Science and Quantitative Thinking
#41: Quality Oversight of CROs-Clinical Vendors Sun, June 15 9:00AM - 5:00PM (Pacific Standard Time) IACET Track 01 - Clinical Operations;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice
#42: Regulatory Affairs for Biologics Sun, June 15 9:00AM - 5:00PM (Pacific Standard Time) IACET Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions
#43: Clinical Statistics for Nonstatisticians Sun, June 15 9:00AM - 5:00PM (Pacific Standard Time) ACPE, CME, IACET, RN Track 01 - Clinical Operations;Track 15 - Statistical Science and Quantitative Thinking
#44: Quality by Design: From Theory to Practice Sun, June 15 9:00AM - 5:00PM (Pacific Standard Time) CME, IACET, RN Track 01 - Clinical Operations;Track 15 - Statistical Science and Quantitative Thinking;Track 15 - Statistical Science and Quantitative Thinking;Track 15 - Statistical Science and Quantitative Thinking
#45: Risk Management Plan Sun, June 15 9:00AM - 5:00PM (Pacific Standard Time) ACPE, CME, IACET, RN Track 14 - Clinical Safety and Pharmacovigilance
#46: The Good Pharmacovigilance Practices In The EU: Lessons Learned and Frequently Asked Implementation Questions Sun, June 15 9:00AM - 5:00PM (Pacific Standard Time) CME, IACET, RN Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance;Track 14 - Clinical Safety and Pharmacovigilance;Track 14 - Clinical Safety and Pharmacovigilance