Search Preconference Tutorials

Tutorials 

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