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Title Event Type Day Time Track(s) Credits
#20: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development Tutorial Sunday, Jun 24 8:30AM - 12:00PM Track 08 - Regulatory Affairs and Submissions IACET
#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them, and How to Respond If Violations Do Occur Tutorial Sunday, Jun 24 8:30AM - 12:00PM Track 08 - Regulatory Affairs and Submissions IACET
#22: Utilizing Chemistry, Manufacturing, and Controls in Drug Development Tutorial Sunday, Jun 24 8:30AM - 12:00PM Track 12 - Pharmaceutical Quality IACET
#23: Global Market Access: Essential Knowledge for Clinical Trial Design Tutorial Sunday, Jun 24 8:30AM - 12:00PM Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) IACET
#24: A Device Primer: 510(k)s, PMAs, IDEs Tutorial Sunday, Jun 24 8:30AM - 12:00PM Track 09 - Medical Diagnostics and Devices CME, IACET
#40: Understanding and Navigating the Regulatory System in China Tutorial Sunday, Jun 24 9:00AM - 5:00PM Track 08 - Regulatory Affairs and Submissions IACET
#41: Quality Oversight of CROs - Clinical Vendors Tutorial Sunday, Jun 24 9:00AM - 5:00PM Track 03 - Innovative Partnering Models and Outsourcing Strategies IACET
#42: Regulatory Affairs for Biologics Tutorial Sunday, Jun 24 9:00AM - 5:00PM Track 08 - Regulatory Affairs and Submissions ACPE, IACET
#43: Clinical Statistics for Nonstatisticians Tutorial Sunday, Jun 24 9:00AM - 5:00PM Track 01 - Clinical Operations ACPE, CME, IACET
#30: Regulatory Affairs in the European Union: An Overview of Registration Procedures for Medicinal Products in the EU Tutorial Sunday, Jun 24 1:00PM - 4:30PM Track 08 - Regulatory Affairs and Submissions IACET
#31: Leadership: How to Organize and Lead People in Group Work Tutorial Sunday, Jun 24 1:00PM - 4:30PM Track 16 - Professional Development IACET, PMI
#32: Designing, Operating and Evaluating Patient Registries Tutorial Sunday, Jun 24 1:00PM - 4:30PM Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) ACPE, CME, IACET, RN
#33: Understanding Comparative Effectiveness Research (CER) in the Biopharmaceutical Industry Tutorial Sunday, Jun 24 1:00PM - 4:30PM Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) ACPE, CME, IACET, RN
#34: Fourteen Steps from Research to Development Tutorial Sunday, Jun 24 1:00PM - 4:30PM Track 08 - Regulatory Affairs and Submissions CME, IACET
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