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Audience: Intermediate [clear filter]
Monday, June 27
 

8:30am

10:00am

10:45am

#144: Root Cause Analysis: Getting to ‘Why’ When Something Goes Wrong in Your Trial Exhibit Hall A #123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America 113B #124: Risk-Based Monitoring in Clinical Trials 113C #127: Innovative Partnerships: gOVERN - A Research and Early Development’s Outsourcing Vision to Enable Resourcing INovation 112AB #128: Alliance Management Forum 111AB #129: Delivering Value Through Medical Information Metrics 203AB #132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned 204C #131: IDMP Update 204B #133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME! 201B #135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers 108B #134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy? 103A #136: Clinical Data Disclosure and Transparency: ClinicalTrials.gov Final Rule, EU Requirements, and Other Key Updates 202AB #137: Using Technology to Make Trials Accessible to More Clinical Trial Participants 204A #138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices 109AB #139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations? 105AB #140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements 108A #141: Transforming Health Care Data for Clinical Research: Strategy and Experiences from the PCORnet Common Data Model 201A #143: Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors 103C

12:15pm

1:00pm

1:30pm

1:45pm

2:30pm

4:30pm

5:15pm

 
Tuesday, June 28
 

8:00am

9:45am

10:30am

#215: Exploring the Use of Virtual Technologies and Virtual Teams Within Medical Affairs Organizations 202AB #218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification 201B #220: Regulatory Changes in China and the Impact to Global Drug Development Planning 109AB #222: Valuing the Clinical Trial Patient 204A #224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How 201A #227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development 103C #208: Measuring Return on Engagement: An Interim Report on the DIA-Tufts CSDD Metrics Study 108B #209: The Promotable Project Manager: Leadership Behaviors Critical to Success in the Life Sciences 102AB #211: Collaboration with a Purpose 111AB #212: Special Populations in Clinical Pharmacology Studies 113A #214: Product Management Strategies: Maximizing Content Re-Use to Meet Diverse Customer Information Needs 203AB #217: Electronic Submissions Gateway: Next Generation 201C #216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step 204C #221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment 103A #223: Global Harmonization: Current ICH Quality Initiatives 112AB #226: The Global Conundrum: Herding Cats - Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi-Country Pharmacovigilance Activities 113C #225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems 113B

10:45am

12:00pm

12:40pm

1:20pm

2:00pm

3:25pm

4:00pm

 
Wednesday, June 29
 

8:00am

9:40am

9:45am

10:30am

12:00pm

12:40pm

1:20pm

2:00pm

#341: eTMF: Selection, Implementation, and What's Next? 204B #351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies 108B #353: The Utility of Natural History Studies in Drug Development and Approval 103C #354: Protocol Optimization: Making It Real Exhibit Hall A #334: Risky Business: Latest Trends, Strategies, and Tools for Predicting Success and Monitoring Risk During Clinical Trial Operations 113B #335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials 113C #336: Effect of International Reference Pricing on Planning for Global New Product Launches 105AB #337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools 112AB #338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection 201A #339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them 203AB #342: Big Data in Health Care and Life Sciences 201C #343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape 201B #344: Companion Diagnostics: Driving New Business Models for Successful Outcomes 103A #345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority? 202AB #346: Anticipating and Responding to Challenges in Issue Management 204A #347: Global Harmonization: Non-ICH Regions 111AB #348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC 107AB #349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements 109AB #352: From Mistakes to Success: Lessons Learned from Organizational Change Management Programs 102AB #350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort? 108A

3:15pm

3:25pm

4:00pm

#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results 105AB #361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep 203AB #367: Quality at the Edge(s): Design It Right and Keep It Going in Non-Interventional Studies 204A #368: Conducting Trials in China 201A #372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes 113C #371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety 113A #374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations 108A #375: Creating Competent Clinical Research Professionals Through Systematic Evidence Review 112AB #359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk 111AB #362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders 204C #363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines 201B #364: Cell and Gene Therapies: Current Global Landscape 204B #365: Cross-Labeling of Drugs and Devices: How Can It Be Done? 103A #366: Infectious Disease Containment and Lessons Learned 202AB #369: Innovative and Emerging Technologies 109AB #370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices 107AB #373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs 113B #376: Pediatric Rare Disease Drug Development 103C
 
Thursday, June 30
 

9:00am

10:45am