会议日程
8:30 AM — 12:00 PM
#20: Leadership: How to Organize and Lead People in a Work Group8:30 AM — 12:00 PM
#22: How to Prepare for an FDA Inspection8:30 AM — 12:00 PM
#23: Signal Detection: Identifying and Managing Safety Signals8:30 AM — 12:00 PM
#26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm8:30 AM — 12:00 PM
#26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm9:00 AM — 5:00 PM
#40: Clinical Statistics for Nonstatisticians9:00 AM — 5:00 PM
#40: Clinical Statistics for Nonstatisticians9:00 AM — 5:00 PM
#42: Analysis of Safety Data from Clinical Trials9:00 AM — 5:00 PM
#43: The Good Pharmacovigilance Practices in the EU: Global Applications10:30 AM — 12:00 PM
Student Session1:00 PM — 4:30 PM
#30: Preparing for a US FDA Advisory Committee Meeting4:15 PM — 5:30 PM
Networking Within Your Company8:30 AM — 10:00 AM
Drug Repurposing: Where Will it Take Us?8:30 AM — 10:00 AM
The Future of Patient Engagement: Measuring What Matters11:00 AM — 12:15 PM
Artificial Intelligence/Machine Learning11:00 AM — 12:15 PM
Breaking Down the Wall for FDA to Leverage Real World Data11:00 AM — 12:15 PM
Calling All Angels to the Valley of Death11:00 AM — 11:30 AM
Career Opportunities in Transitions in Life Science11:00 AM — 12:15 PM
Counting on Safety11:00 AM — 12:15 PM
Data Sharing: 2017 and Beyond11:00 AM — 12:15 PM
Designing and Implementing a Robust Pharmacovigilance System for Vaccines11:00 AM — 12:15 PM
Effective Life Cycle Management11:00 AM — 12:15 PM
Engage and Exchange Student Forum11:00 AM — 12:15 PM
Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies11:00 AM — 12:15 PM
FDA Rare Disease Town Hall11:00 AM — 12:15 PM
GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial11:00 AM — 12:15 PM
Globalization of Medical Affairs Departments11:00 AM — 12:15 PM
Leveraging Wearables and Sensors in Clinical Trials and mHealth11:00 AM — 12:15 PM
Patient Engagement: 4 W's and an H11:00 AM — 12:15 PM
Postmarketing Safety Studies: Approaches and Regulatory Insights11:00 AM — 12:15 PM
Submission Dossiers: Communications Excellence to Drive Speed and Quality11:00 AM — 12:30 PM
Update from the CFDA11:00 AM — 12:15 PM
We Can't Forget the Children in This Process11:45 AM — 12:15 PM
A Day in the Life of A....1:15 PM — 1:45 PM
Day in the Life of A…Part 23:00 PM — 4:30 PM
Opening Remarks and Keynote Address8:00 AM — 9:30 AM
Paying for Value in Biopharmaceuticals: Trends in the United States8:00 AM — 9:30 AM
People Will Talk: Gathering Insights from Digital Listening8:00 AM — 9:30 AM
Radical Technologies: Changing the Future of Biopharmaceuticals9:30 AM — 10:30 AM
Effective Team Management in Global Trials10:30 AM — 11:00 AM
A Risk-Based Approach to Quality Management for RWE Studies10:30 AM — 11:45 AM
Accelerating Drug Development Through Innovation10:30 AM — 11:45 AM
Big Data: Regulatory Information10:30 AM — 11:30 AM
Cardiac Safety10:30 AM — 11:45 AM
Evolving Data Standards and Regulations10:30 AM — 11:45 AM
Global Harmonization: Mutual Recognition10:30 AM — 11:45 AM
International Collaboration in Times of Public Health Crisis10:30 AM — 11:45 AM
Outcomes Standardization: An Imperative to Value Assessments10:30 AM — 11:45 AM
Pharmacovigilance Inspections: Hot Topics and Proactive Approaches10:30 AM — 11:45 AM
Recent Trends in Asian Regulations for Drug Development: What is Coming Next?10:30 AM — 11:45 AM
Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?10:30 AM — 11:45 AM
Safety Evaluation: Transforming Information into Evidence10:30 AM — 11:45 AM
Sharing the Burden10:30 AM — 11:45 AM
The New Business Reality for the Medical Science Liaison Community10:30 AM — 11:30 AM
Update from CBER: Advancing the Development of Complex Biologic Products10:45 AM — 11:45 AM
Healthy CRO/Sponsor Relations: “Sole” Mate or Flavor of the Month12:00 PM — 1:00 PM
DIA Communities Luncheon12:00 PM — 12:45 PM
QuintilesIMS Innovation Theater: Changing Trials Through Analytics: How it Works12:45 PM — 1:30 PM
PowerUp!12:45 PM — 1:45 PM
Strategies for Communicating with FDA1:15 PM — 1:45 PM
Strategies for Managing Difficult Stakeholders2:00 PM — 3:15 PM
Best Practice for Advisory Committee Meeting Preparation2:00 PM — 3:15 PM
Big Data: Current and Emerging Technologies2:00 PM — 3:15 PM
Building the Medical Strategy and Tactics2:00 PM — 3:15 PM
Clinical Relevant Specifications: Leveraging Principles of QbD2:00 PM — 3:00 PM
Comparative Effectiveness: State of the Art and Stakeholder Perspectives2:00 PM — 3:00 PM
Data and Privacy Protection2:00 PM — 3:15 PM
FDA Session: Electronic Submissions and Data2:00 PM — 3:15 PM
Leveraging Wearables and Sensors in Clinical Trials: Case Studies2:00 PM — 3:00 PM
Mergers and Acquisitions: Due Diligence Considerations2:00 PM — 3:15 PM
Mobile Health: Participatory Research2:00 PM — 3:15 PM
New Considerations in Benefit-Risk Management2:00 PM — 3:15 PM
New Trial Design Approaches: Including New Endpoints2:00 PM — 3:15 PM
Not Your Grandma's Patient Advocacy Group Anymore2:00 PM — 3:15 PM
Novel Techniques for Improving Clinical Trial Subject Retention2:00 PM — 3:15 PM
Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 22:00 PM — 3:15 PM
Regulatory Challenges with Next Generation Sequencing2:00 PM — 3:15 PM
Strategic Planning Across Research Organizations2:00 PM — 3:15 PM
What’s New in Devices: European Medical Device Regulations and MDUFA IV4:00 PM — 5:15 PM
Big Data: Genomics and Personalized Medicine4:00 PM — 5:15 PM
Breaking Down the Wall for Global Regulators to Leverage Real World Data4:00 PM — 5:15 PM
Brexit: Where Are We Now?4:00 PM — 5:15 PM
Challenges and Issues in Early-Phase Oncology Trials4:00 PM — 5:00 PM
Combination Products4:00 PM — 5:15 PM
Creating Adaptive Contents for a Multichannel World4:00 PM — 5:15 PM
Data Quality4:00 PM — 5:15 PM
Developing Pharmacovigilance Policy Based on Impact4:00 PM — 5:15 PM
Effective Collaboration Between Sponsors and Medical Writing Vendors4:00 PM — 5:00 PM
FDA Session: Health IT at FDA4:00 PM — 5:00 PM
Microbiome: Innovative Therapeutics, Challenges, and Opportunities4:00 PM — 5:15 PM
Next Generation Patient Recruitment: Part 1 of 24:00 PM — 5:15 PM
Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 24:00 PM — 5:15 PM
PMDA Town Hall4:00 PM — 5:15 PM
Quality Metrics: The Carrot or the Stick?4:00 PM — 5:15 PM
Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More5:30 PM — 6:30 PM
DIA Study Endpoints Community Meeting8:00 AM — 9:30 AM
Does Diversity Matter in Clinical Trials?8:00 AM — 9:30 AM
International Regulatory Convergence8:00 AM — 9:30 AM
Progress in Pediatric Therapeutics9:30 AM — 10:30 AM
Mergers and Acquisitions: First, Do No Harm10:30 AM — 11:45 AM
Big Data: Combining Registries and Legacy Clinical Trial Databases10:30 AM — 11:45 AM
CRISPR: Regulatory Challenges in the Gene Editing Revolution10:30 AM — 11:45 AM
Effective Collaborations: Navigating the Grey Space10:30 AM — 11:45 AM
Evolution of Novel Registration Endpoints as Diseases Become Chronic10:30 AM — 11:45 AM
How to Engage Patients Within Medical Affairs10:30 AM — 11:45 AM
Is the Future Bright for Treatment of Neurodegenerative Diseases?10:30 AM — 11:45 AM
Keys to Effective Product Launch Preparation10:30 AM — 11:45 AM
Leading in the Midst of Ambiguity10:30 AM — 11:45 AM
Managing Acceleration and Quality In Product Development10:30 AM — 11:45 AM
Measuring and Advancing the Clinical Quality Management System10:30 AM — 11:45 AM
Multiregional Clinical Trials and the ICH E1710:30 AM — 11:45 AM
New Frontiers in Pharmaceutical Manufacturing10:30 AM — 11:45 AM
New Site Paradigm: Just in Time Sites10:30 AM — 11:45 AM
Next Generation Patient Recruitment: Part 2 of 210:30 AM — 11:45 AM
Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation10:30 AM — 11:30 AM
Quantified Self Tracking10:30 AM — 11:45 AM
Quantitative Metrics to Capture the Value of Patient Engagement10:30 AM — 11:45 AM
Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness10:30 AM — 11:45 AM
The Brave New World: The Ongoing Globalization of Pharmacovigilance10:45 AM — 11:45 AM
Patient Perspective11:15 AM — 11:45 AM
Information Quality in EHR Computer Systems12:45 PM — 1:45 PM
Real-World Application of Risk-Based Monitoring2:00 PM — 3:15 PM
Big Data: Management and Analytics2:00 PM — 3:00 PM
Biosimilars and Generics: Access Versus Innovation2:00 PM — 3:00 PM
Cultural Diversity2:00 PM — 3:15 PM
Digital Innovations for Medical Information Contact Centers2:00 PM — 3:15 PM
EMA Policy 0070: A Game Changer for Industry2:00 PM — 3:15 PM
Expanded Access and Compassionate Use2:00 PM — 3:15 PM
Exploring the Evolution of Signal Detection2:00 PM — 3:15 PM
Global Perspective on ICH: Part 1 of 22:00 PM — 3:15 PM
Life Cycle Management: ICH Q122:00 PM — 3:15 PM
Off-Label Communications to Health Care Providers and Consumers2:00 PM — 3:15 PM
Pharmacovigilance 2.0: Redesigning for the Future2:00 PM — 3:15 PM
Risk-Based Monitoring: Convergence of Technology, Processes, and People2:00 PM — 3:15 PM
Understanding the New Common Rule and Its Impact to Industry2:45 PM — 3:15 PM
Online Health Communities: A New Frontier in Health Research3:15 PM — 4:00 PM
Medical Affairs and KOL Management4:00 PM — 5:15 PM
Are We Ready for Telemedicine-Powered Clinical Trials?4:00 PM — 5:15 PM
Automation and Innovation in Clinical Trial Safety Assessment4:00 PM — 5:15 PM
Changing Environments Within Pharmacovigilance4:00 PM — 5:15 PM
EHRs/eSource and Emerging Data Streams4:00 PM — 5:15 PM
FDA Update on Prescription Drug Promotion4:00 PM — 5:00 PM
FDA–Health Canada Regulatory Cooperation Council Town Hall4:00 PM — 5:15 PM
Global Perspective on ICH: Part 2 of 24:00 PM — 5:15 PM
How Is Digital Patient Engagement Impacting Trial Participation?4:00 PM — 5:15 PM
Lessons Learned from the Sarepta Exondys 51 Approval4:00 PM — 5:15 PM
Looking to the Future for EU Pediatric Investigation Plans4:00 PM — 5:15 PM
Maximizing Success in Partner Collaborations4:00 PM — 5:15 PM
Next Generation Predictive Analytics4:00 PM — 5:15 PM
Patient-Centric Development Assessment4:00 PM — 5:15 PM
Safety Issues in First-in-Human Studies4:00 PM — 5:15 PM
The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator5:30 PM — 6:30 PM
DIA Clinical Safety and Pharmacovigilance Community Meeting9:00 AM — 10:30 AM
FDA Forum10:45 AM — 12:00 PM
EMA/ FDA Question Time10:45 AM — 11:45 AM
Evolving Clinical Trial Guidance and Regulations: Am I Ready?10:45 AM — 12:00 PM
Exploration of Metabolic Diseases: Is the Liver the New Heart?10:45 AM — 12:00 PM
Flexing Your Project Management Muscles Outside of Traditional Roles10:45 AM — 12:00 PM
How Do You Build a Collaborative Community? What Advice Would You Give?10:45 AM — 12:00 PM
Of Course My Data Has Integrity … And I Can Prove It10:45 AM — 12:00 PM
Online Patient Networking10:45 AM — 12:00 PM
Recruiting Rare Disease Patients: A Unique Set of Challenges10:45 AM — 12:00 PM
Trial Master File: MHRA/EMA Inspections and Sponsor Audit Learnings