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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 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;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 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;Track 15 - Statistical Science and Quantitative Thinking;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;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 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;Track 15 - Statistical Science and Quantitative Thinking;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;Track 14 - Clinical Safety and Pharmacovigilance;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;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
A Common Decision Framework for Health Technology Assessment and Regulatory Agencies: Is This of Benefit to Stakeholders? Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
Beyond Operational Excellence: A Survey on Sponsor Expectations of Preferred Business Partners Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Bringing the Patient Voice to Clinical Development Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Central Statistical Monitoring Revealed: How to Enhance Data Quality and 'De-Risk' Studies Through Enhanced Risk-Based Monitoring Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research;Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Data Warehousing and Integration: Current Status, Key Success Ingredients and Alternative Approaches for Maximizing the Value of Your Data Symposium Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Delivering Value Through Medical Content to Health Care Providers Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Design and Sample Size Planning for Multiregional Clinical Trials Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
DIA 2014 Student Forum: Maintaining Your Career - Continuing Education and Changing Your Track Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Does One Size Fit All? Understanding the Impact of Cultural Differences Across the Globe Workshop Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Formal Dispute Resolution at CDER: When, Why, and How Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Global Clinical Trials Symposium: Opportunities and Challenges Symposium Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Global Pediatric Development: We Are Making Progress Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Implementation of Quality by Design: Progress Update Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Making Better Go/No-Go Decisions: Improving Success Rates and Reducing Costs Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
New Approaches to International Collaboration Between Regulators (Part 1 of 2) Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
One Paddle for Two Boats? Policy Alternatives to Buoy Adoption of Precision Therapies and Their Companion Diagnostics Forum Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Pioneering Regenerative Medicine: Trends in Regulations for New Therapy Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Protocol Deviations: Finding the Yellow Brick Road (Part 1 of 2) Workshop Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Risk Management in the US, EU, and Asia: Where Are We Now? Session Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Stage Gate Decision-Making Workshop (Part 1 of 2) Workshop Monday, Jun 16 8:30AM - 10:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
The Twitter Value Proposition for Life Science Professionals Workshop Monday, Jun 16 8:30AM - 10:00AM (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 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Assessment of Impact and Effectiveness of Risk Management and Minimization in the EU and US Symposium Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Defining, Measuring, and Assessing "Fit for Purpose" Quality in a Risk-Based Monitoring Model: Industry and Agency Perspectives Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Driving Toward Standardization: Overcoming Barriers - eDM, eTMF, and CTMS Symposium Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Effective Communication Model Between Drug Safety, Regulatory Affairs, and Clinical Development Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Electronic Clinical Outcome Assessments: Coming to a Device Near You! Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Engaging Patients through Digital and Social Media Communities Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Fact or Fiction: Patient Engagement in the Drug Development Process Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
FDA Regulation of Therapeutic Products Derived from Human Stem Cells: Successfully Navigating the Regulatory Hurdles Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Improving Returns on Invested Capital in the Pharmaceutical and Biotechnology Industry Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Narrative Medicine: How to Tap into the Inherent Power of Words and Stories in the Clinical Trial Process Workshop Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, RN
New Approaches to International Collaboration Between Regulators (Part 2 of 2) Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 18 - Global Regulatory;Track 19 - Executive Program CME, IACET, RN
Observational Studies of Comparative Effectiveness: How to Recognize Good Practice Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Pediatric Drug Development: Lessons Learned During FDASIA Implementation Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Pricing, Economics, Reimbursement, Market Share (PERMS) Strategy: An Interactive Holistic Approach in Rare Diseases Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics;Track 17 - Rare/Orphan Diseases CME, IACET, RN
Proarrhythmic Risk Assessment WITHOUT the Thorough QT: FDA and Pharmaceutical Company Perspectives Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Protocol Deviations: Finding the Yellow Brick Road (Part 2 of 2) Workshop Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
R&D and Technology Outsourcing Today: An Industry Update Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Regulatory Submissions: Better, Faster, and Cheaper Symposium Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Risk Sharing or Risk Transfer? Striking the Perfect Balance in Strategic Partnerships Forum Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Stage Gate Decision-Making Workshop (Part 2 of 2) Workshop Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Strategic Quantitative Thinking: Designing a Roadmap for Innovation Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Why Waste Time and Money? Data Standards from the Beginning: Working Together for Good Science and Good Submissions Session Monday, Jun 16 11:00AM - 12:30PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
INC Research Innovation Theater: “Organizing for Change”… Lessons Learned in Preparing a Global Organization for Innovation Special Session Monday, Jun 16 1:00PM - 2:00PM (Pacific Standard Time) Track 21 - Innovation Theater
Plenary Session & Keynote Address Forum Monday, Jun 16 2:30PM - 4:00PM (Pacific Standard Time) Opening Plenary - Keynote Address
Benefit-Risk Throughout the Product Life Cycle: How Should Benefit-Risk Be Evaluated and Communicated from Development through Marketing as New Information Emerges? Symposium Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Big Data, Big Impact: New Levels of Strategic Partnerships Between Sponsors-CROs Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Bioinformatics and Translational Medicine Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Capital Efficient Drug Development with Revolutionary Technologies: Calculated Risks Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, PMI, RN
CDRH Town Hall Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 18 - Global Regulatory CME, IACET, RN
Clinical Outcomes Assessment and Patient Engagement Symposium Symposium Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
CMC Development of Breakthrough Therapies Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Collaboration in R&D: What’s New for TransCelerate BioPharma? Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 19 - Executive Program ACPE, CME, IACET, RN
Communicating Clinical Trial Results: Targeting the Patient Audience Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Covering Industry Trends in the Biomedical Industry Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 20 - Late-breaking Topics IACET
Drug Development and the Virtual Company Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Effective Leadership in Hybrid Team Between West and East Asia in New Drug Development Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Electronic Source Data in Clinical Investigations (Part 1 of 2): Regulatory Considerations Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Mitigating Missing Data in Clinical Trials: Moving Toward Global Behavioral Change Impacts Efficacy, Safety, and Quality Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Monitor Training: Building Essential Skills for Implementing Risk-Based Monitoring - Data Interpretation, Quality by Design Workshop Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Nanotechnology: Application to Medical Products Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development ACPE, CME, IACET, RN
PDUFA V New Molecular Entity Program: History, Implementation and Future of the Program Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Prescription Drug Marketing Regulatory Primer Workshop Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Quality and Risk Management in an Increasingly Complex Clinical Research Environment: State of the Industry and Leading Practices Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Regulated Product Submissions and eCTD 4: The Path to Progress Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Regulatory and GCP Quality Trends in Emerging Markets Session Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances, and Precision Medicine (Part 1 of 2) Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 19 - Executive Program;Track 19 - Executive Program CME, IACET, RN
The Regulatory Intelligence Function: Evolution Over the Past Decade in an Expanded Global Marketplace Session Tuesday, Jun 17 8:00AM - 9:00AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Updated Strategies for Effective Recruitment of Patients in Clinical Trials Forum Tuesday, Jun 17 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Using Comparative Effectiveness Research to Make Health Care Decisions: Exploring the Environment, Opportunities, and Challenges Through Real-World Examples Session Tuesday, Jun 17 8:00AM - 9:00AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
ConvergeHEALTH by Deloitte Innovation Theater: Personalized Medicine Studies and Real-World Analytics for Oncology: M2Gen and ConvergeHEALTH Collaboration Special Session Tuesday, Jun 17 9:45AM - 10:15AM (Pacific Standard Time) Track 21 - Innovation Theater
Development of an Integrated Orphan Drug Framework in Canada Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Device and Diagnostic Innovation Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Drug Development with Reimbursement in Mind: Obtaining the Input of Payers to Inform Clinical Trial Design Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
Efficient Distribution of Information Across Documents to Support Product's Benefit-Risk Ratio for Patients Worldwide Workshop Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Electronic Source Data in Clinical Investigations (Part 2 of 2): Practical Implementation Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
EMA-FDA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Europe Town Hall Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
FDA Programs to Encourage Innovation: Maximizing the Opportunities and Confronting the Challenges of New Product Development Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
GCP Inspection Findings: A Roundtable Discussion Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Health Care's Revolutionary Printing Press? 3D Printing - Blue Sky and Regulatory Path Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Impact of Bayesian Methods in Drug Development with a Focus on Comparative Effectiveness Research Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Improving Communication in the Informed Consent Process: The Advantages of eConsent Workshop Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Improving the Informed Consent Process Symposium Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Industry Trends, Successes, and Failures in Orphan and Rare Disease Therapeutics Forum Tuesday, Jun 17 10:30AM - 11:30AM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Juvenile Animal Studies and Pediatric Nonclinical Development Session Tuesday, Jun 17 10:30AM - 11:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Manufacturing Challenges for Breakthrough Products Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
National Strategy to Bridge the Gap Between Academic Innovation and Commercialization in Asia Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Networking: It's Not What You Know, But Who You Know! Workshop Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, RN
Preparing for a Successful Product Launch Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Risk-Based Monitoring: From Concept to Practice Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Social Listening as a Tool to Inform Study Teams on Social Media Strategy for Recruitment and Building Patient-Centric Trials Forum Tuesday, Jun 17 10:30AM - 11:30AM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
The Changing Landscape for Bioinnovation: The Emergence of Small Pharma, Strategic Alliances, and Precision Medicine (Part 2 of 2) Forum Tuesday, Jun 17 10:30AM - 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 08 - Regulatory Affairs and Submissions;Track 19 - Executive Program CME, IACET, RN
The State of Clinical Outsourcing: Do Outsourcing Partnerships Promote or Impede Progress Toward Clinical Trial Optimization? Forum Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Understanding Corporate Integrity Agreements/Trends: What Can We Expect and Why Is It Important? Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Update on Postmarketing Safety Reporting Session Tuesday, Jun 17 10:30AM - 12:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison;Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Covance Innovation Theater: Risk-Based Monitoring - Seeing the Forest for the Trees When Designing and Deploying an Enterprise Process Special Session Tuesday, Jun 17 11:45AM - 12:30PM (Pacific Standard Time) Track 21 - Innovation Theater
Veeva Innovation Theater: Industry’s Largest eTMF Survey: Benchmarks and Insights Special Session Tuesday, Jun 17 12:45PM - 1:15PM (Pacific Standard Time) Track 21 - Innovation Theater
Adapting GCPs to Evolving Drug Development Paradigm (Part 1 of 2) Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Asia Town Hall Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Breakthrough Therapy Designation: One Year After Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Challenges and Strategic Approaches to Development of a Novel Biologic Versus a Biosimilar Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn't) Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 19 - Executive Program CME, IACET, RN
Computer System Validation in the Cloud: Cloud Is Here Today and Here to Stay Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Dare to Be Different: Comparing Biosensor Data to Patient-Reported Outcomes Data - Learnings from Asthma Session Tuesday, Jun 17 1:30PM - 2:30PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Digital Health: Mobile Medical Apps and the Future of Health Care Delivery Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 07 - Processes and Technologies for Clinical Research;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
EMA-FDA GCP Initiative: Current Status and Future Perspectives Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Embracing Change: The New Face of Clinical Data Management Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Enabling Participants' Access to the Electronic Clinical Trial Data: The Blue Button Project Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 07 - Processes and Technologies for Clinical Research;Track 20 - Late-breaking Topics ACPE, CME, IACET, RN
FDA Enforcement Update: Advertising and Promotion Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
How Do We Keep Kids Safe? Pediatric Safety Monitoring From Beginning to End Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
How to Make a Successful Electronic Registration and Listing Submission: NDC, Regulatory Compliance, and Technical Requirements Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Improving Investigative Site Selection Practices Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
In-Sourcing, Out-Sourcing: Where Do We Go from Here? Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Introducing CDER's Office of Pharmaceutical Quality Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality;Track 18 - Global Regulatory CME, IACET, PMI, RN
Optimization of and Enhancements to Interactive Response Technology to Ensure Efficient Investigational Product and Study Material Management Symposium Tuesday, Jun 17 1:30PM - 2:30PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Organs on a Chip: The Future of Efficacy and Safety Testing Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 14 - Clinical Safety and Pharmacovigilance;Track 20 - Late-breaking Topics CME, IACET, RN
Predictive Enrichment: Design, Development Strategies, and Methodological Issues Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Promotional Material Management: From Review to Submission – Contemporary Ideas Session Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Unraveling Evidence-Based Medicine: A Scientific, Ethical, and Socio-Political Analysis Forum Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Virtual Teams in Clinical Development Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Who’s Moving the PV Cheese? Three Game Changing Topics - Impact of Emerging New Requirements for E2B (R3), ICSR Quality Standards, and Benefit-Risk Management Symposium Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Yes and ... Applying Improvisational Skills to Improve Innovation Workshop Tuesday, Jun 17 1:30PM - 3:00PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, RN
BBK Worldwide Innovation Theater: Adopting New Strategies for the New Face of Patient Recruitment Special Session Tuesday, Jun 17 2:45PM - 3:15PM (Pacific Standard Time) Track 21 - Innovation Theater
Adapting GCPs to Evolving Drug Development Paradigm (Part 2 of 2) Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice ACPE, CME, IACET, RN
Assessing Comparative Effectiveness Research Feasibility and Interpretability A Priori Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Building a Site Budget from the Ground Floor Workshop Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Development of Central Nervous System Drugs with Abuse Potential Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning ACPE, CME, IACET, RN
Electronic Standardized Study Data: Regulatory Considerations Forum Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Evaluating Potential Contribution of Social Media to Postmarketing Medication Safety Surveillance Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
FDA - Health Canada Regulatory Cooperation Council (RCC) Town Hall Forum Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 18 - Global Regulatory CME, IACET, RN
Gene Therapy Symposium Symposium Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
How a New Collaboration Between a Biopharmaceutical Company and a CRO Is Improving the Quality, Speed, and Efficiency of Drug Development Forum Tuesday, Jun 17 3:30PM - 4:30PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies ACPE, CME, IACET, RN
International Regulatory Advertising and Promotion Considerations Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Key Subgroup Analysis Issues in Clinical Trials Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Lessons Learned in the Development and Registration of Fixed-Dose Combination Products: CMC Focus Forum Tuesday, Jun 17 3:30PM - 4:30PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Managing Innovation: Challenges and Opportunities Today and for the Future Workshop Tuesday, Jun 17 3:30PM - 5:00PM (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 17 - Rare/Orphan Diseases CME, IACET, RN
Misconduct and Management of Serious or Continued Noncompliance: Differences, Similarities, and Building a World-Class Program Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Orphan Drugs and Treatment of Rare Diseases in Asia Symposium Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Our First Year Under Sunshine: Impact on Medical and Scientific Communications Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Patient Registries: Designing, Implementing, and Leveraging to Accelerate Clinical Trials Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Perfecting the Protocol: Designing Studies for Success Symposium Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Power Up! Give Your Brain a Vacation Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 20 - Late-breaking Topics
Prequalification of Medicines for Neglected Tropical Diseases Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
The Pharmacovigilance System Master File: Business as Usual? Can This File Help Industry? Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
The Regulatory Writing Game Show Workshop Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Transforming Culture and Mindsets to Deliver a Higher Quality eTMF Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Using a Hub and Spoke Model to Drive Efficiency and Cost-Effectiveness in the Global Regulatory Process Session Tuesday, Jun 17 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Utilizing 505(b)(2) to Accelerate Drug Development Plans Session Tuesday, Jun 17 3:30PM - 4:30PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Achieving Success in a Mega-Trial Sponsor/ARO/CRO Collaboration: Approaches to Overcome Challenges and Optimize Results Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Balancing Manufacturing Quality Improvements and Drug Shortage Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality ACPE, CME, IACET, RN
CDISC BRIDG Implementation: A Model for System Interoperability and as a Data Base Model Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Changing Global Regulatory Climates: Effects on Companion Diagnostics and Combination Products Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Clinical Trials Technology Implementation: Bringing Together Patient- and Site-Centric Approaches Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Designing Smarter and More Cost-Effective Phase 1 Protocols Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
ICH Update: Emerging Guidelines Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Innovative Engagement Strategies to Inspire Higher Level Commitment and Performance Workshop Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
International Cooperation in Rare Disease Research Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Leveraging Electronic Health Record Data to Understand Clinical Nuance in Complex Real-World Populations: A Case Study Forum Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Life Cycle Management of Biopharmaceuticals: An Approach and Lessons Learned for an Imperative Business Practice Session Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Metrics Benchmarking, Predictive Analytics, and Virtual Population Simulation: New Tools to Contextualize and Forecast Trial Performance Symposium Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Optimizing Outsourcing Relationships: Data-Driven Strategies to Support Vendor Selection, Negotiation, and Management Symposium Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Professional Career Development Within Medical Affairs: A Perspective from Medical Communications, Medical Science Liaisons, and Medical Writers Session Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Proprietary Name Review: International Perspectives from the FDA, Health Canada, and EMA Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Regulatory Strategic Plan: Don’t Start Development Without One Workshop Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Research Site Quality Compliance Programs: Review of Industry Gold Standards Workshop Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Seeing Is Believing! Good Graphic Design Principles for Medical Research Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Signal Detection: Challenges and Strategic Aspects Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
The Challenges of High Quality Risk Management with Single Shared System REMS and Physician Knowledge Surveys Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
The Legal, Ethical, and Commercial Issues Impacting the Development and Accessibility of Pediatric Medicines Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
The Sites Have Spoken: Implementing Paperless Trials and Risk-Based Monitoring from a Site’s Perspective Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Transforming ICH Toward Greater Global Harmonization Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality;Track 18 - Global Regulatory CME, IACET, RN
Why Does Drug Development Need Project Management? Session Wednesday, Jun 18 8:00AM - 9:00AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Your Future Success as a Master’s Level Statistician: Learn from the Past of These Industry Masters Forum Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking IACET
Appirio Innovation Theater: The Big R&D Leap: Accelerating Pharmaceutical Innovation and Discovery Through Crowdsourcing Special Session Wednesday, Jun 18 9:45AM - 10:15AM (Pacific Standard Time) Track 21 - Innovation Theater
An International Approach to Benefit-Risk Assessment of Medicines: An Evaluation by a Consortium of Established Agencies Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 18 - Global Regulatory CME, IACET, RN
Approaches to Decrease the Time Gap Between FDA Approval and the Ability to Market a DEA Scheduled Drug Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Be a Change Agent: Leveraging Communication and Training Tools to Help Promote Project and Career Transformation Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 16 - Professional Development ACPE, CME, IACET, PMI, RN
Career Planning and Limitations for Mid- to Upper-Level Project Managers Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, RN
Clinical Supply Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Combination Products: An Overview of Clinical Benefits, Regulatory Issues, and Manufacturing Challenges Workshop Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Expanding the Scope: Empowering the Public in Pharmacovigilance Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Field-Based Medical Communications on a Global Scale Session Wednesday, Jun 18 10:30AM - 11:30AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
From the Protocol to the Patient: Clinical Trial Data Disclosure Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products ACPE, CME, IACET, RN
GCP Audits in a Risk-Based Environment Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Implementation of GDUFA: Progress and Expectations Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Maximizing the Potential of Your EDC System Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Prediction of Safety: An Evolving Field for Selecting Low-Risk Compounds Towards an Effective Life Cycle of a Product Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Project Management Basics: Creating a High-Level Project Plan Workshop Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Public-Private Partnerships: An Innovative Strategy for Patient Registries Workshop Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Risk-Based Monitoring Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Separating Perceptions from Reality in the Acceptance of Adaptive Trials by Regulatory Agencies Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Site Certification of Early Phase Research Units: An International Perspective Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Site Selection and Feasibility Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
Strengthening Public Policy for Sustainable Clinical Research Enterprise in Africa, Asia, and South America: Progress and Prospects Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
The Patient Point-of-View: An Unrehearsed but Revealing Conversation to Rectify Patient Enrollment Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 20 - Late-breaking Topics ACPE, CME, IACET, RN
The Present and Future of Pharmaceutical Development Outsourcing: Where Are We Today and Where Are We Going? Forum Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Update from the FDA-EMA Parallel Assessment Pilot Session Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, PMI, RN
Vendor Selection for a Small Company Forum Wednesday, Jun 18 10:30AM - 11:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
SAS/JMP Innovation Theater: Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP Clinical Special Session Wednesday, Jun 18 11:45AM - 12:15PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice;Track 21 - Innovation Theater
SAS Innovation Theater: Data Transparency and Sharing: Research Benefits, Risks and the Future Special Session Wednesday, Jun 18 12:30PM - 1:15PM (Pacific Standard Time) Track 21 - Innovation Theater
A Cloud-Based Approach to Evaluating and Maintaining Global Regulatory Content Alignment Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research;Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Abstract and Article Publication Opportunities with DIA Workshop Wednesday, Jun 18 1:30PM - 3:00PM (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 17 - Rare/Orphan Diseases IACET
Adaptive, Progressive or Risk-Based Licensing Models: What Approaches Could Be Considered by Mature and Emerging Markets? Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Benefit-Risk Assessments of Medicines: Framework Development and Use in Marketing Applications Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Broadening Health Care Communications: Learnings from Health Authority Initiatives Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Challenges and Opportunities Facing FDA’s International Posts Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 18 - Global Regulatory CME, IACET, RN
Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 1 of 2) Workshop Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Complex Drug Projects: Complex Project Management Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Costing Strategies for Sustainable Drug Development Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
EU Clinical Trial Data Transparency Debate: Where Are We? Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Exploring Bayesian Approaches Applied to New Treatments for Rare Diseases Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking;Track 17 - Rare/Orphan Diseases CME, IACET, RN
Functional Service Provider Relationships: Critical Factors to Ensuring Long-Term Success Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Hot Topics in Patient Recruitment: Global Demographics, Underrepresented Populations, and the Science Behind Patient Communications Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Innovative Direct-to-Patient Study Model to Capture PRO Instrument Validation Data for Submission to a Regulatory Authority Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Making Comments Count: Best Practices in Developing Comments for a Global Audience Workshop Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Managing Global Teams: Navigating Through Cultural, Lingual, and Geographic Challenges Session Wednesday, Jun 18 1:30PM - 2:30PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development CME, IACET, PMI, RN
Medical Device Update: Unique Device Identification Rule, Medical Device Reporting Draft Guidance, and Postmarketing Clinical Research Reporting Requirements Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Natalizumab and Progressive Multifocal Leukoencephalopathy: A Risk Management Case Study Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Nesting Studies Within Patient Registries to Support Comparative Effectiveness Research Workshop Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics ACPE, CME, IACET, RN
Optimizing Orphan Drug Development and Using Appropriate Methodology: Key Tips for Success Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Phase 1 Studies in Renal and Hepatic Subjects: Considerations and Best Practices in Design and Conduct Forum Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Recent Advancement of the Pharmaceutical Inspection Cooperation Scheme and Good Manufacturing Practices in the Asia Pacific Region Session Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Social Media in Patient Recruitment: How to Best Leverage the Digital Ecosystem Symposium Wednesday, Jun 18 1:30PM - 3:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
The Role of Intelligent Signaling in Digital Disease Detection and Proactive Pharmacovigilance Session Wednesday, Jun 18 1:30PM - 2:30PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Benefit-Risk Evaluation in Drug Development Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 2 of 2) Workshop Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
CMC Regulatory Pathways in the Emerging Markets: Focus on Asia Pacific Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, RN
Compliance, Potential Financial Implications, and Impact of New Safety Measures Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Effective Strategic Partnering Between Small Pharmaceutical Companies and CROs: Discussion and Case Study Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
End-to-End Data and Metadata in Today's Clinical Trials Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
Filling the Gaps and Speeding Up Results: What an Educated, Sophisticated Patient Population Can Do for You Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Health Authority Meeting Preparation: There Are No Do-Overs Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Industry in the Sunshine: How the “Sunshine” Provisions of the Affordable Care Act Will Change Industry Policy and Practice Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
Informed Medication Use in Pregnancy: A Collaborative Approach to Address Needs for Data, Communication, and Engagement Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 20 - Late-breaking Topics ACPE, CME, IACET, RN
Optimize Protocol Design: A Path to Efficient, Lower Cost Trial Execution Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 01 - Clinical Operations ACPE, CME, IACET, RN
Patient Voice in Decision Making: How Are Regulators Making This Work? Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 10 - Public Policy/Health Care Compliance/Law CME, IACET, RN
Pediatric Trials: Improvements through Bayesian Methods, Adaptive Designs, and Modeling/Simulation Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking ACPE, CME, IACET, RN
Powering Up Communications: Improving the Information Exchange Between Patients and Industry Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison ACPE, CME, IACET, RN
Predicting Drug Off-Target Protein Binding to Hypothesize Mechanisms for Safety Issues Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development CME, IACET, RN
Product Crisis Management: Crisis, What Crisis? Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Project Management Plays Critical Roles in the New Challenging Environment Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Regulatory Challenges for Orphan Medicines Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Regulatory Perspectives in the Execution of Clinical Studies and Medical Product Commercialization in Asia Pacific Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Sustainable Solutions for Global Clinical Research Site Documentation Symposium Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research CME, IACET, RN
The Realities of Late Life Cycle Management for Very Old Legacy Brands Forum Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
The Sponsor-Vendor-Vendor Relationship: A Fine Balance Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Transforming Organizational Knowledge into Product Information: Can Structured Authoring Save the Day? Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Why, When, and How Should Patients Be Involved in the Benefit-Risk Assessment of Medicines? Session Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
Women as Transformational Leaders Workshop Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Accelerating Research in a Large Health Care System: Streamlining Research Review and Study Initiation Workshop Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 01 - Clinical Operations CME, IACET, RN
CDER Town Hall (Part 1 of 2) Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 18 - Global Regulatory ACPE, CME, IACET, RN
Exploring Responder-Patient Clinical Study Design Approaches Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning ACPE, CME, IACET, RN
FDA Drug Claims Substantiation after IMS and Caronia: Will Court Scrutiny Based on the First Amendment Lead to Change in Current Policy and Practice? Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World;Track 10 - Public Policy/Health Care Compliance/Law ACPE, CME, IACET, RN
GCP Quality Agreements Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
Hot Topics in Medical Devices Labeling: US and Global Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products CME, IACET, RN
Independent Consultant or Permanent Role: Get the Position You Want (Tips from Insiders) Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, RN
Keeping It Together: Syncing CRO Data and Metrics Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, RN
Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments Forum Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 15 - Statistical Science and Quantitative Thinking CME, IACET, RN
Qualifying a Software Vendor in a Regulated Industry Session Thursday, Jun 19 9:00AM - 10:00AM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
Question-Based Review (QbR): A Risk-Based, Standardized Pharmaceutical Quality Assessment Tool Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, PMI, RN
Safety in Special Situations: Stem Cells, Vaccines, and Combination Products Symposium Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 14 - Clinical Safety and Pharmacovigilance ACPE, CME, IACET, RN
Today's Dynamic Medical Science Liaison Environment Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 06 - Medical Communication, Medical Writing, and Medical Science Liaison CME, IACET, RN
Universal Health Coverage and Health Technology Assessment in Emerging Asia Pacific Countries Session Thursday, Jun 19 9:00AM - 10:30AM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
A Hitchhiker's Guide to Working with Management Consultants Workshop Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 02 - Project/Portfolio Management and Strategic Planning CME, IACET, PMI, RN
Bringing Quality to Quality Metrics Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 11 - Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice CME, IACET, RN
CDER Town Hall (Part 2 of 2) Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 18 - Global Regulatory ACPE, CME, IACET, RN
Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 14 - Clinical Safety and Pharmacovigilance CME, IACET, RN
Ethnic Difference in Clinical Trial Data: A 15-Year History of an Investigation by Regulatory Agencies and Industry Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 08 - Regulatory Affairs and Submissions ACPE, CME, IACET, RN
How Can Studies that Inform Relative Effectiveness Best Be Incorporated into Global Drug Development Plans? Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 13 - Comparative Effectiveness Research/Global Health Outcomes and Economics CME, IACET, RN
Innovative Patient Recruitment Solutions for Rare Disease Clinical Trials Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 17 - Rare/Orphan Diseases ACPE, CME, IACET, RN
Parents as Partners: Overcoming Unique Challenges to Pediatric Recruitment and Retention Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 01 - Clinical Operations;Track 17 - Rare/Orphan Diseases CME, IACET, RN
Risk-Based Monitoring: Where We Are and Where We Are Headed Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 07 - Processes and Technologies for Clinical Research ACPE, CME, IACET, RN
The Evolution of Strategic Partnerships and the Four P's of International Relationship Building Forum Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 03 - Innovative Partnering Models and Outsourcing Strategies CME, IACET, PMI, RN
Trends in Biosimilars Regulation Within Developed and Emerging Markets Session Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions CME, IACET, RN
Walking the Tightrope of Talent Acquisition and Retention: The Balancing Act for Maintaining Productivity, Efficiency, and Quality Symposium Thursday, Jun 19 10:45AM - 12:15PM (Pacific Standard Time) Track 16 - Professional Development CME, IACET, PMI, RN