Agendas
The DIA Annual Meeting, the largest multidisciplinary event that brings together a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.
8:30 AM — 12:00 PM
#21: Leadership: How to Organize and Lead People in a Work Group8:30 AM — 12:00 PM
#23: How to Prepare for an FDA Inspection8:30 AM — 12:00 PM
#23: How to Prepare for an FDA Inspection8:30 AM — 12:00 PM
#25: Signal Detection: Identifying and Managing Safety Signals9:00 AM — 5:00 PM
#40: Analysis of Safety Data from Clinical Trials9:00 AM — 5:00 PM
#41: Quality Oversight of CROs-Clinical Vendors9:00 AM — 5:00 PM
#42: Fundamentals of ANDA Submissions and FDA Expectations Under GDUFA9:00 AM — 5:00 PM
#43: Clinical Statistics for Nonstatisticians9:00 AM — 5:00 PM
#44: Risk Management and Safety Communication Strategies9:00 AM — 5:00 PM
#45: The Good Pharmacovigilance Practices in the EU: Global Applications1:00 PM — 4:30 PM
#31: Preparing for a US FDA Advisory Committee Meeting1:00 PM — 4:30 PM
#35: Ethical Issues in Clinical Trials8:30 AM — 10:00 AM
Clinical Quality Management Systems in the New Millennium8:30 AM — 10:00 AM
Comprehensive Control Strategy: Building Confidence in Quality8:30 AM — 10:00 AM
Enabling Next Generation Sequencing Within Global Clinical Trials8:30 AM — 10:00 AM
Forward Progress Through Collaboration: Internal and External to the FDA8:30 AM — 10:00 AM
Health Canada's Approach to Achieve Regulatory Harmonization: An Update8:30 AM — 10:00 AM
Project Management of Adaptive Trials: Infrastructure and Methodology8:30 AM — 10:00 AM
Risk Management Plans Ten Years On: Where Are We Now and Where Are We Going?8:30 AM — 10:00 AM
The Growing Role of the Patient Leading Into PDUFA VI: Negotiations and 20169:30 AM — 4:30 PM
Student Posters (MONDAY)11:00 AM — 12:30 PM
Clinical Quality by Design: From Theory to Practice11:00 AM — 12:30 PM
Codevelopment of a Drug in the Pharmaceutical Industry: Is It Ever Fun?11:00 AM — 12:30 PM
Facilitating Rare Disease Patient Participation in Clinical Trials11:00 AM — 12:30 PM
Global Drug Development in China: Opportunities and Challenges for Innovation11:00 AM — 12:00 PM
Integrating Patient Engagement with EHR Data and eSource for Better Studies11:00 AM — 12:30 PM
New Pandemics: Lessons Learned from the Ebola Experience11:00 AM — 12:00 PM
Next Generation Nanomedicines and Nanosimilars: Regulators’ Perspective11:00 AM — 12:30 PM
Reducing Drug Shortages11:00 AM — 12:30 PM
The What, Why and How of Coaching and Its Application in the Work Place2:30 PM — 4:00 PM
Plenary Session & Keynote Address8:00 AM — 9:30 AM
Can We Talk? Alternative Strategies for Communicating with FDA8:00 AM — 9:30 AM
FDA GCP Compliance and Enforcement Updates8:00 AM — 9:30 AM
Global Regulation of Advanced Therapies8:00 AM — 9:00 AM
How to Succeed in Orphan Drug Regulatory Affairs8:00 AM — 9:30 AM
Implementing Risk-Based Monitoring8:00 AM — 9:00 AM
Learning By Doing: Regulatory Applications for Breakthrough Therapies8:00 AM — 9:30 AM
New Approaches to Submission Components8:00 AM — 9:30 AM
New Challenges for a Data Monitoring Committee8:00 AM — 9:30 AM
Pediatric Therapeutic Development: From Policy to Portfolios to Patients8:00 AM — 9:30 AM
PMDA Town Hall8:00 AM — 9:30 AM
Prescription Drug Marketing Regulatory Primer8:00 AM — 9:30 AM
Safety in Special Situations: Vaccines, Stem Cells and Beyond8:00 AM — 9:30 AM
The Art and Science of Portfolio Management8:00 AM — 9:30 AM
The Development of Patient Power: From Consumer to Active Participant!9:00 AM — 4:00 PM
Professional Poster Session 1 (TUESDAY)9:30 AM — 10:30 AM
Tuesday Oral Presentations - Professional Poster Session 1A10:30 AM — 12:00 PM
Breakthrough Medicines or Affordable Health Care: Do We Have to Choose?10:30 AM — 11:30 AM
Efficient Authoring of Submission Documents10:30 AM — 12:00 PM
FDA Enforcement Update: Advertising and Promotion10:30 AM — 12:00 PM
FDA Study Data Technical Conformance Guide (Part 1 of 2): An Overview10:30 AM — 12:00 PM
How Pharmaceutical Companies Can Engage Responsibly with Patients Online10:30 AM — 12:00 PM
How to Trust Data from Wearable Devices Used in Clinical Trials10:30 AM — 12:00 PM
Networking: It's Not What You Know, But Who You Know!10:30 AM — 12:00 PM
Office of Pharmaceutical Quality Update10:30 AM — 12:00 PM
Recent Trends in Facilitating Decision Making in Drug Development10:30 AM — 12:00 PM
Regulation of Combination Products in the 21st Century10:30 AM — 11:30 AM
Taking the Pulse of Outsourcing Relationship Structures and Their Impact10:30 AM — 12:00 PM
The State of Pediatric Research in the United States11:35 AM — 1:32 PM
Tuesday Oral Presentations - Professional Poster Session 1B1:30 PM — 2:30 PM
Collaborate to Innovate: Exploring a Seconds Market1:30 PM — 2:30 PM
Continuous Improvement and Innovation in Manufacturing Approaches1:30 PM — 3:00 PM
Disruptive Forces in Health Care Innovation: Where Are They Leading Us?1:30 PM — 3:00 PM
Roadmap to Measuring Clinical Trial Quality1:30 PM — 3:00 PM
Tool Is a Good Four-Letter Word2:30 PM — 3:10 PM
Tuesday Oral Presentations - Professional Poster Session 1C3:30 PM — 5:00 PM
Bringing Clinical Trial Practices into the 21st Century3:30 PM — 5:00 PM
CDRH Town Hall3:30 PM — 5:00 PM
CMC/GMP: Risk-Based Regulatory Review3:30 PM — 5:00 PM
Conflict Resolution: Helping Teams Manage Through Conflict3:30 PM — 5:00 PM
Data and Evaluation Needed for Robust Evidence: Regulators' Challenges3:30 PM — 5:00 PM
Getting the Most Out of Scientific Advice in the US and EU3:30 PM — 5:00 PM
Has the New Format PSUR/PBRER Achieved What Was Originally Intended?3:30 PM — 5:00 PM
Innovative Approaches to Patient Registries for Evaluating Outcomes3:30 PM — 5:00 PM
Leadership and Process in Medical Writing3:30 PM — 5:00 PM
Pediatric Clinical Trials: One Size Does Not Fit All3:30 PM — 4:30 PM
Pediatric Drug Development3:30 PM — 5:00 PM
Predictive Subgroup Methodologies and Molecular Basket Designs3:30 PM — 5:00 PM
Progress Report on Emerging Nations and Regulatory Capacity Building3:30 PM — 5:00 PM
The Free Exchange of Truthful and Non-Misleading Medical Information8:00 AM — 9:30 AM
Challenges in Managing Global Regulatory Divergence8:00 AM — 9:30 AM
Keys to Managing a Successful Regulatory Strategy and Submission8:00 AM — 9:30 AM
Leveraging Diverse Patient Insights8:00 AM — 9:30 AM
Patient Registries: Design, Development, and Recruitment8:00 AM — 9:30 AM
The Future of Clinical Trial Data Sharing8:00 AM — 9:30 AM
The Impact of the eLabeling Rule on Industry and Stakeholders9:00 AM — 4:00 PM
Professional Poster Session 2 (WEDNESDAY)9:30 AM — 10:30 AM
Wednesday Oral Presentations - Professional Poster Session 2A10:30 AM — 12:00 PM
Best Evidence Generation: Regulatory Perspectives10:30 AM — 12:00 PM
Direct-to-Patient Strategies That Are Changing the Landscape of Clinical Trials10:30 AM — 12:00 PM
Electronic Standardized Data in Regulatory Submissions10:30 AM — 12:00 PM
FDA Sentinel Initiative10:30 AM — 12:00 PM
How Can International Guidances Enable Global Regulatory Convergence?10:30 AM — 12:00 PM
Integrated Cardiac Safety10:30 AM — 12:00 PM
Medicine Development and Authorization: A Patient-Centered Approach10:30 AM — 12:00 PM
Opening the Door to Data Transparency: What's the Verdict?10:30 AM — 12:00 PM
Orphan Drug Development Challenges: Case Studies10:30 AM — 12:00 PM
Pharmacovigilance Inspections: Achieving Compliance in a Global Environment10:30 AM — 12:00 PM
Power Up! Give Your Brain a Break!10:30 AM — 12:00 PM
The Role of Labeling in Successful Human Factors Studies11:35 AM — 1:30 PM
Wednesday Oral Presentations - Professional Poster Session 2B12:00 PM — 12:30 PM
SAS Innovation Theater: Accelerate Value-Based Drug Development With Analytics1:30 PM — 3:00 PM
A Global Update on Orphan Drugs1:30 PM — 3:00 PM
Big and MultiStream Data for Drug Evaluation: The Promise and Cautions1:30 PM — 3:00 PM
Cardiac Safety Considerations in Pediatric Drug Development1:30 PM — 3:00 PM
CBER Town Hall: Innovation and Public Health Response1:30 PM — 3:00 PM
Frontier Issues in Electronic Information Integrity Today1:30 PM — 3:00 PM
Issue Resolution in Clinical Partnerships1:30 PM — 2:30 PM
Regulatory Framework for Medical Devices in Europe1:30 PM — 3:00 PM
Risk-Based Inspections and Compliance1:30 PM — 3:00 PM
Searching for the Gold Nuggets: Text Analysis in Clinical Data1:30 PM — 3:00 PM
The Challenges, Solutions and Right To Try Surrounding Expanded Access1:30 PM — 3:00 PM
Using Data Analytics to Detect Quality Issues1:30 PM — 3:00 PM
Using Games and Play to Create an Innovative Learning Experience2:30 PM — 3:10 PM
Wednesday Oral Presentations - Professional Poster Session 2C3:30 PM — 5:00 PM
Accountable Care Organizations and Integrated Health Care3:30 PM — 5:00 PM
Adapting Risk Management Principles to Nontraditional R&D Settings3:30 PM — 5:00 PM
Asia Town Hall: Asia as a Drug R&D Center in the World3:30 PM — 5:00 PM
CIOMS IX: Practical Approaches to Risk Minimization and Its Evaluation3:30 PM — 5:00 PM
Enforcement Update and Trends From a Global Perspective3:30 PM — 5:00 PM
Knowledge Management for the Product Life Cycle3:30 PM — 5:00 PM
Speaking and Publishing Opportunities with DIA3:30 PM — 5:00 PM
Statistical Support of Risk-Based Monitoring3:30 PM — 5:00 PM
The State of Informatics at CDER and CBER9:00 AM — 10:00 AM
Aha: Moments of Breakthrough Thinking Leading to New Opportunities9:00 AM — 10:30 AM
An Insider’s View of Cooperation Between the EMA and CDER/FDA: Question Time9:00 AM — 10:30 AM
Innovations in Strategic Alliances and Overcoming Obstacles9:00 AM — 10:00 AM
Novel Data Sources and Tools for Pharmacovigilance9:00 AM — 10:30 AM
Survey Results: How Project Managers Leverage Tools and Techniques9:00 AM — 10:00 AM
The Ultimate in Patient-Centered Trials: Bringing Study Visits into the Home10:45 AM — 11:45 AM
A Systematic Approach to Study Start-Up10:45 AM — 12:15 PM
CDER Town Hall10:45 AM — 12:15 PM
Global Developments in the Regulation of Biological Therapeutics10:45 AM — 11:45 AM
Making Technology a Key Component of Your Learning Strategy10:45 AM — 12:15 PM
The Future of Pharmacovigilance Operations