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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