DIA
Drug Information Association Logo

Advanced Search

Search Program

Search Program 

Title Event Type Day Time Track(s) Credits
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
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
Clinical Supply Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations 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
Site Selection and Feasibility Symposium Symposium Wednesday, Jun 18 10:30AM - 12:00PM (Pacific Standard Time) Track 01 - Clinical Operations 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
ICH Update: Emerging Guidelines Session Wednesday, Jun 18 8:00AM - 9:30AM (Pacific Standard Time) Track 12 - Pharmaceutical Quality CME, IACET, 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Women as Transformational Leaders Workshop Wednesday, Jun 18 3:30PM - 5:00PM (Pacific Standard Time) Track 16 - Professional Development 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
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
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
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
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
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
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
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
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
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
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
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
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