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#21: Leadership: How to Organize and Lead People in a Work Group
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Tutorial
|
Sunday, Jun 14
|
8:30AM - 12:00PM
|
Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 04 - Preclinical 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 Liaisons;Track 07 - Technology/Data/Records and Submissions;Track 08 - Regulatory Affairs;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 (GCP);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;Track 18 - Global Regulatory;Track 19 - Late-breaking Topics;Track 20 - Innovation Theater;Track 21 - Poster Presentations
|
IACET, PMI
|
|
#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
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Tutorial
|
Sunday, Jun 14
|
8:30AM - 12:00PM
|
Track 01 - Clinical Operations;Track 06 - Medical Communication/Medical Writing and Medical Science Liaisons;Track 08 - Regulatory Affairs
|
IACET
|
|
#23: How to Prepare for an FDA Inspection
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Tutorial
|
Sunday, Jun 14
|
8:30AM - 12:00PM
|
Track 01 - Clinical Operations;Track 08 - Regulatory Affairs;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP)
|
CME, IACET, RN
|
|
#23: How to Prepare for an FDA Inspection
|
Tutorial
|
Sunday, Jun 14
|
8:30AM - 12:00PM
|
Track 01 - Clinical Operations;Track 08 - Regulatory Affairs;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP)
|
CME, IACET, RN
|
|
#25: Signal Detection: Identifying and Managing Safety Signals
|
Tutorial
|
Sunday, Jun 14
|
8:30AM - 12:00PM
|
Track 01 - Clinical Operations;Track 14 - Clinical Safety and Pharmacovigilance
|
ACPE, CME, IACET, RN
|
|
#40: Analysis of Safety Data from Clinical Trials
|
Tutorial
|
Sunday, Jun 14
|
9:00AM - 5:00PM
|
Track 14 - Clinical Safety and Pharmacovigilance;Track 15 - Statistical Science and Quantitative Thinking
|
ACPE, CME, IACET, RN
|
|
#41: Quality Oversight of CROs-Clinical Vendors
|
Tutorial
|
Sunday, Jun 14
|
9:00AM - 5:00PM
|
Track 01 - Clinical Operations;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP)
|
IACET
|
|
#42: Fundamentals of ANDA Submissions and FDA Expectations Under GDUFA
|
Tutorial
|
Sunday, Jun 14
|
9:00AM - 5:00PM
|
Track 08 - Regulatory Affairs
|
CME, IACET, RN
|
|
#43: Clinical Statistics for Nonstatisticians
|
Tutorial
|
Sunday, Jun 14
|
9:00AM - 5:00PM
|
Track 01 - Clinical Operations;Track 15 - Statistical Science and Quantitative Thinking
|
ACPE, CME, IACET, RN
|
|
#44: Risk Management and Safety Communication Strategies
|
Tutorial
|
Sunday, Jun 14
|
9:00AM - 5:00PM
|
Track 08 - Regulatory Affairs;Track 14 - Clinical Safety and Pharmacovigilance
|
ACPE, CME, IACET, RN
|
|
#45: The Good Pharmacovigilance Practices in the EU: Global Applications
|
Tutorial
|
Sunday, Jun 14
|
9:00AM - 5:00PM
|
Track 07 - Technology/Data/Records and Submissions;Track 08 - Regulatory Affairs;Track 14 - Clinical Safety and Pharmacovigilance
|
CME, IACET, RN
|
|
#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
|
Tutorial
|
Sunday, Jun 14
|
1:00PM - 4:30PM
|
Track 08 - Regulatory Affairs;Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics
|
IACET
|
|
#31: Preparing for a US FDA Advisory Committee Meeting
|
Tutorial
|
Sunday, Jun 14
|
1:00PM - 4:30PM
|
Track 01 - Clinical Operations;Track 08 - Regulatory Affairs
|
IACET
|
|
#32: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation
|
Tutorial
|
Sunday, Jun 14
|
1:00PM - 4:30PM
|
Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 04 - Preclinical 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 Liaisons;Track 07 - Technology/Data/Records and Submissions;Track 08 - Regulatory Affairs;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 (GCP);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;Track 18 - Global Regulatory;Track 19 - Late-breaking Topics;Track 20 - Innovation Theater;Track 21 - Poster Presentations
|
IACET
|
|
#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
|
Tutorial
|
Sunday, Jun 14
|
1:00PM - 4:30PM
|
Track 01 - Clinical Operations;Track 09 - Medical Devices/In Vitro Diagnostics and Combination Products;Track 14 - Clinical Safety and Pharmacovigilance
|
ACPE, CME, IACET, RN
|
|
#35: Ethical Issues in Clinical Trials
|
Tutorial
|
Sunday, Jun 14
|
1:00PM - 4:30PM
|
Track 01 - Clinical Operations;Track 08 - Regulatory Affairs;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP);Track 14 - Clinical Safety and Pharmacovigilance
|
CME, IACET, RN
|