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Saturday, June 25
 

9:00am

 
Sunday, June 26
 

8:00am

8:30am

9:00am

11:45am

12:30pm

1:00pm

2:45pm

4:15pm

 
Monday, June 27
 

6:30am

7:00am

7:30am

8:30am

#106: Fostering a Partnership to Advance Innovation: Niche Service Leads to Breakthrough in Patient Recruitment and Retention Challenges 112AB #117: IDMP: A Compliance Project or a New Way of Conducting Business? 109AB #101: Opportunities for Improving Informed Consent of Clinical Research Volunteers 113C #102: Digital Health Debate 113A #103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science 113B #104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy 105AB #105: Maximize the Value of Your Product by Beginning with the End in Mind 107AB #107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost 202AB #113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements 108B #108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness? 203AB #109: EHR in Clinical Research: Heralding a New Era 201C #110: Updates and Pending Issues in the US Biosimilar Environment 201B #111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring? 204B #112: The Upcoming European Clinical Trials Regulation 204C #114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward 204A #115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product 111AB #116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment? 103C #118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data 201A #119: Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Clinical Trials 102AB #120: DIA 2016: Student Forum 108A #121: Rare Disease Clinical Trials: Coping with Unique Challenges 103A

9:30am

10:00am

10:45am

#142: Why We All Need Mentors (and How to Be a Good Mentor to Others) 107AB #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 #125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration 113A #126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development 102AB #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 #130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial 201C #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

11:45am

12:15pm

1:00pm

1:30pm

1:45pm

2:30pm

4:00pm

4:15pm

4:30pm

5:15pm

5:30pm

 
Tuesday, June 28
 

7:00am

8:00am

9:00am

9:30am

9:40am

9:45am

10:30am

#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

11:30am

12:00pm

12:40pm

1:20pm

1:30pm

2:00pm

#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

3:25pm

4:00pm

#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
 
Wednesday, June 29
 

7:00am

8:00am

9:00am

9:30am

9:40am

9:45am

10:30am

#320: Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials 201A #312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies 113C #314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End 203AB #318: Changes to Common Rule Likely Affecting FDA-Governed Research 202AB #322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence 107AB #327: FDA–Health Canada Regulatory Cooperation Council Town Hall 201C #307: Mythbusting Site Productivity: Referral Practices and Untapped Site Options 108A #308: Patient Recruitment Workshop: Survey Results and Practical Application 102AB #310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch 108B #309: Global Stakeholder Management: Across the Ocean Between East and West 105AB #311: Outsourcing: Assessing CRO Performance and Challenges 111AB #313: The Future of Clinical Research Data: 2020 and Beyond 204B #315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My! 201B #316: What’s Your Preference? The Emerging Importance of Patient Preference Elicitation 204C #317: Global Medical Device Development: Regulatory Concordance or Discordance? 103C #319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development 204A #321: Office of Pharmaceutical Quality Update 113B #323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation 113A #324: Implementing Adaptive Designs Involves Greater Teamwork 109AB #325: Reinventing You: How to Change Your Career Fearlessly! 112AB #326: FDA Rare Disease Town Hall 103A

10:45am

11:30am

12:00pm

12:40pm

1:20pm

1:30pm

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 #333: Hearing the Patient Voice in Pharma and What Patients Want You to Know 113A #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 #340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research 204C #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

3:00pm

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 #357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects 108B #358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages 102AB #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
 

8:00am

9:00am

10:30am

10:45am