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Tuesday, June 28

7:00am EDT

8:00am EDT

9:00am EDT

9:30am EDT

9:40am EDT

9:45am EDT

10:30am EDT

#207: Advancing the Appropriate Use of Mobile Clinical Trials: The Clinical Trials Transformation Initiative 108A #213: FDA Enforcement Update: Advertising and Promotion 107AB #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 #210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management 105AB #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 #219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development 204B #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 EDT

11:30am EDT

12:00pm EDT

12:40pm EDT

1:20pm EDT

1:30pm EDT

2:00pm EDT

#235: Global Clinical Supply Logistics Study 113A #237: Acquisitions and Mergers: When Companies’ Regulatory Operations Systems and Processes Converge 112AB #252: Capturing Real-World Data in Rare Diseases 103C #253: Update from Health Canada 202AB #255A: DIA Innovation Theater: Special Session for Exhibitors: Global Trends in Drug Development and Opportunities with DIA Worldwide Exhibit Hall B #255B: Lost in Translation: The Importance of Data Presentation Exhibit Hall A #234: TransCelerate's Risk-Based Monitoring: Sharing What We Are Learning 109AB #236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations 108B #238: Prescription Drug Marketing Regulatory Primer 107AB #240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards 204B #239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views 201C #241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease 201B #242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology 108A #243: Patient Involvement Today and Tomorrow: What’s in It for Patients? 204C #244: Transforming Clinical Development Through Enterprise Quality Management 204A #245: Risk-Based Inspections 111AB #246: Valuing the Signal and the Noise in Health Care Horizon Scanning 103A #247: Fit for Purpose and Modern Validity Theory in PROs 105AB #248: Mind the Gaps: The Science of Designing, Implementing, and Evaluating Benefit-Risk Communication for Medicinal Products 113C #249: Current Topics for Pharmacovigilance in Japan 113B #250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics 201A #251: Embracing Virtual Training Solutions in 2016: Focus on Performance! 102AB #254: CBER Town Hall: State of the Center and Plans for the Future 203AB

3:00pm EDT

3:25pm EDT

4:00pm EDT

#262: Solving Challenges and Employing Best Practices in Medical Information Contact Centers 201A #269: Making Quality Stick: Building a Complete Quality Culture 204A #278: Real Life Application of Risk-Based Monitoring Exhibit Hall A #257: Mobile Apps for Clinical Trials: DIY or AMAZON Strategy? When to Build, When to Buy 113A #259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies 112AB #260: A Risk-Benefit Approach to Planning Early Clinical Development 113C #261: Marketing After Amarin and Pacira 107AB #263: Patient Centricity in Clinical Trials 201B #264: FDA Update on Data Standards 204B #265: Enabling Innovative New Endpoint Measurement Using Mobile Technology 203AB #266: Perspectives on Expanded Access to Investigational New Drugs 108A #267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development? 105AB #268: Emerging Biopharma Therapeutic Modalities: Scientific and Policy Implications 201C #270: Implementing Knowledge Management: Industry Perspectives 111AB #271: The Things Kids Say: Clinical Outcome Assessments in Pediatric Clinical Trials 103A #272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance? 113B #273: Improving Adverse Drug Reaction Information in Product Labels 109AB #274: Statistical Issues in the Evaluation of Biosimilars 108B #275: Creating a Competency-Based Onboarding and Learning Program on a Budget 102AB #276: Using Input from Patient Communities to Develop PRO Instruments 103C #277: PMDA Town Hall 202AB