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DIA 2016 Annual Meeting
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Preconference Tutorial
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Trk 01: Clinical Operations
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Trk 02: Proj-Port Mgt-Strat Planning
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Workshop
Trk 02: Proj/Port Mgt/Strat Planning
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Trk 03: Innov Part Model-Outsourcing
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Trk 03: Innov Part Model/Outsourcing
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Trk 04: Preclin Transl-Early Clin Dev
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Trk 05: Reg of Prod Adv-Mkting
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Trk 05: Reg of Prod Adv/Mkting
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Trk 06: Med Comm-Wrtg-MSL
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Trk 06: Med Comm/Wrtg/MSL
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Trk 07: Tech-Data- Records-Subs
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Trk 07: Tech/Data/ Records/Subs
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Trk 08: Reg Affairs
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Trk 09: Med Devices-InVitro-CombProd
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Trk 09: Med Devices/InVitro/CombProd
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Trk 10: Pub Pol-HealthCare Compl-Law
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Trk 10: Pub Pol/HealthCare Compl/Law
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Trk 11: Quality in CT-GCP
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Trk 11: Quality in CT/GCP
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Trk 12: Pharm Quality
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Trk 13: CER-Glob Health Econ
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Trk 13: CER/Glob Health Econ
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Trk 14: Clin Safety-PV
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Trk 14: Clin Safety/PV
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Trk 15: Statistics
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Trk 16: Prof Development
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Trk 17: Rare-Orphan Diseases
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Trk 17: Rare/Orphan Diseases
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Trk 18: Global Regulatory
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Trk 20: Innov Theater
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Trk 21: Poster Presentations
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Trk 22: Engage and Exchange
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Trk 23: Opening Plenary
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Saturday
, June 25
TBA
9:00am •
Exhibitor Registration Open
Sunday
, June 26
102AB
8:30am •
#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
1:00pm •
#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
103A
8:30am •
#23: How to Prepare for an FDA Inspection
1:00pm •
#31: Preparing for a US FDA Advisory Committee Meeting
103C
8:30am •
#21: Leadership: How to Organize and Lead People in a Work Group
104AB
8:30am •
#24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China
1:00pm •
#34: Ethical Issues in Clinical Trials
105AB
8:30am •
#25: Signal Detection: Identifying and Managing Safety Signals
1:00pm •
#32: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation
107AB
8:30am •
#20: The Sunshine Act: Understanding the Essentials of Compliance
1:00pm •
#33: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
108A
8:30am •
#26: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
1:00pm •
#37: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
111AB
9:00am •
#40: Analysis of Safety Data from Clinical Trials
112AB
9:00am •
#41: A Rare Disease Program Case Study: Strategies for Successful Outcomes
113A
9:00am •
#42: Clinical Statistics for Nonstatisticians
113B
9:00am •
#43: Risk Management and Safety Communication Strategies
113C
9:00am •
#44: The Good Pharmacovigilance Practices in the EU: Global Applications
202AB
2:45pm •
#001: Powerful Presentations
4:15pm •
#002: Networking: It's Personal - Understanding Yourself and Others to Maximize Personal Interaction
Liberty Ballroom A
11:45am •
Annual Meeting of Members
TBA
8:00am •
Registration for Full Day and Morning Preconference Tutorials Open
8:00am •
Exhibitor Registration Open
12:30pm •
Registration for Afternoon Preconference Tutorials, Conference Attendees, and Speakers
Monday
, June 27
102AB
8:30am •
#119: Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Clinical Trials
10:45am •
#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development
103A
8:30am •
#121: Rare Disease Clinical Trials: Coping with Unique Challenges
10:45am •
#134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy?
103C
8:30am •
#116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment?
10:45am •
#143: Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors
104A
7:30am •
Annual Meeting Orientation and Networking
10:00am •
Speaker Training Session
105AB
8:30am •
#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
10:45am •
#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?
107AB
8:30am •
#105: Maximize the Value of Your Product by Beginning with the End in Mind
10:45am •
#142: Why We All Need Mentors (and How to Be a Good Mentor to Others)
108A
8:30am •
#120: DIA 2016: Student Forum
10:45am •
#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements
108B
8:30am •
#113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements
10:45am •
#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
109AB
8:30am •
#117: IDMP: A Compliance Project or a New Way of Conducting Business?
10:45am •
#138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices
111AB
8:30am •
#115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product
10:45am •
#128: Alliance Management Forum
112AB
8:30am •
#106: Fostering a Partnership to Advance Innovation: Niche Service Leads to Breakthrough in Patient Recruitment and Retention Challenges
10:45am •
#127: Innovative Partnerships: gOVERN - A Research and Early Development’s Outsourcing Vision to Enable Resourcing INovation
113A
8:30am •
#102: Digital Health Debate
10:45am •
#125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration
113B
8:30am •
#103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science
10:45am •
#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America
113C
8:30am •
#101: Opportunities for Improving Informed Consent of Clinical Research Volunteers
10:45am •
#124: Risk-Based Monitoring in Clinical Trials
201A
8:30am •
#118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data
10:45am •
#141: Transforming Health Care Data for Clinical Research: Strategy and Experiences from the PCORnet Common Data Model
201B
8:30am •
#110: Updates and Pending Issues in the US Biosimilar Environment
10:45am •
#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!
201C
8:30am •
#109: EHR in Clinical Research: Heralding a New Era
10:45am •
#130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial
202AB
8:30am •
#107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost
10:45am •
#136: Clinical Data Disclosure and Transparency: ClinicalTrials.gov Final Rule, EU Requirements, and Other Key Updates
203AB
8:30am •
#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?
10:45am •
#129: Delivering Value Through Medical Information Metrics
204A
8:30am •
#114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward
10:45am •
#137: Using Technology to Make Trials Accessible to More Clinical Trial Participants
204B
8:30am •
#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?
10:45am •
#131: IDMP Update
204C
8:30am •
#112: The Upcoming European Clinical Trials Regulation
10:45am •
#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned
Ballroom AB
2:30pm •
#151: Plenary Session and Keynote Address
Exhibit Hall
9:30am •
Coffee Break
11:45am •
Luncheon
4:00pm •
Opening Reception
5:30pm •
Student Poster Awards Ceremony
Exhibit Hall A
10:45am •
#144: Root Cause Analysis: Getting to ‘Why’ When Something Goes Wrong in Your Trial
12:15pm •
#145: Student Poster Session and Oral Presentations 1A
12:15pm •
#147: Interpreting Meaningful Change on PRO Instruments: Methods in Action
1:30pm •
#149: EMA's Publication Policy 0070: Best Practices for Implementation
4:15pm •
#152: Student Poster Session and Oral Presentations 1B
Exhibit Hall B
10:00am •
#122: DBMS Consulting/Clinical Ink Innovation Theater: Accelerating Clinical Trial Innovation: Technology Case Studies for Improving Data Collection, Monitoring, and Medical Coding Processes
12:15pm •
#146: Tata Consultancy Services Innovation Theater: Data Transparency Initiative: An Innovative Solution
1:00pm •
#148: PAREXEL Innovation Theater: Balancing Rapid Approval with Demonstration of Value
1:45pm •
#150: Quintiles Innovation Theater: Evidence Optimization: Fueling Smarter Clinical Development and Value Generation
4:30pm •
#153: BBK Innovation Theater: Reimagining the Patient Experience Through mHealth Technologies
5:15pm •
#154: ConvergeHealth by Deloitte Innovation Theater
TBA
7:00am •
Attendee, Speaker, and Exhibitor Registration Open
7:00am •
Coffee and Light Refreshments
9:30am •
Exhibit Hall Open
TBD
6:30am •
CISCRP Medical Heroes Appreciation 5K
9:30am •
Student Poster Session
Tuesday
, June 28
102AB
10:30am •
#209: The Promotable Project Manager: Leadership Behaviors Critical to Success in the Life Sciences
2:00pm •
#251: Embracing Virtual Training Solutions in 2016: Focus on Performance!
4:00pm •
#275: Creating a Competency-Based Onboarding and Learning Program on a Budget
103A
10:30am •
#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment
2:00pm •
#246: Valuing the Signal and the Noise in Health Care Horizon Scanning
4:00pm •
#271: The Things Kids Say: Clinical Outcome Assessments in Pediatric Clinical Trials
103ABC
8:00am •
#202: Changing Cultures to Advance Patient Engagement
103C
10:30am •
#227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development
2:00pm •
#252: Capturing Real-World Data in Rare Diseases
4:00pm •
#276: Using Input from Patient Communities to Develop PRO Instruments
104A
9:45am •
Speaker Training Session
105AB
10:30am •
#210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management
2:00pm •
#247: Fit for Purpose and Modern Validity Theory in PROs
4:00pm •
#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
107AB
10:30am •
#213: FDA Enforcement Update: Advertising and Promotion
12:00pm •
Innovation Row Tour
2:00pm •
#238: Prescription Drug Marketing Regulatory Primer
4:00pm •
#261: Marketing After Amarin and Pacira
108A
10:30am •
#207: Advancing the Appropriate Use of Mobile Clinical Trials: The Clinical Trials Transformation Initiative
2:00pm •
#242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology
4:00pm •
#266: Perspectives on Expanded Access to Investigational New Drugs
108B
10:30am •
#208: Measuring Return on Engagement: An Interim Report on the DIA-Tufts CSDD Metrics Study
2:00pm •
#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations
4:00pm •
#274: Statistical Issues in the Evaluation of Biosimilars
109AB
10:30am •
#220: Regulatory Changes in China and the Impact to Global Drug Development Planning
2:00pm •
#234: TransCelerate's Risk-Based Monitoring: Sharing What We Are Learning
4:00pm •
#273: Improving Adverse Drug Reaction Information in Product Labels
111AB
10:30am •
#211: Collaboration with a Purpose
2:00pm •
#245: Risk-Based Inspections
4:00pm •
#270: Implementing Knowledge Management: Industry Perspectives
112AB
10:30am •
#223: Global Harmonization: Current ICH Quality Initiatives
2:00pm •
#237: Acquisitions and Mergers: When Companies’ Regulatory Operations Systems and Processes Converge
4:00pm •
#259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies
113A
10:30am •
#212: Special Populations in Clinical Pharmacology Studies
2:00pm •
#235: Global Clinical Supply Logistics Study
4:00pm •
#257: Mobile Apps for Clinical Trials: DIY or AMAZON Strategy? When to Build, When to Buy
113B
10:30am •
#225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems
2:00pm •
#249: Current Topics for Pharmacovigilance in Japan
4:00pm •
#272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance?
113C
10:30am •
#226: The Global Conundrum: Herding Cats - Identifying Risk Across Pharmacovigilance Networks and Seeking Simplicity in Multi-Country Pharmacovigilance Activities
2:00pm •
#248: Mind the Gaps: The Science of Designing, Implementing, and Evaluating Benefit-Risk Communication for Medicinal Products
4:00pm •
#260: A Risk-Benefit Approach to Planning Early Clinical Development
114
8:00am •
#201: International Regulatory Convergence, Collaboration, and Cooperation
201A
10:30am •
#224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How
2:00pm •
#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics
4:00pm •
#262: Solving Challenges and Employing Best Practices in Medical Information Contact Centers
201B
10:30am •
#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
2:00pm •
#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
4:00pm •
#263: Patient Centricity in Clinical Trials
201C
10:30am •
#217: Electronic Submissions Gateway: Next Generation
2:00pm •
#239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views
4:00pm •
#268: Emerging Biopharma Therapeutic Modalities: Scientific and Policy Implications
202AB
10:30am •
#215: Exploring the Use of Virtual Technologies and Virtual Teams Within Medical Affairs Organizations
2:00pm •
#253: Update from Health Canada
4:00pm •
#277: PMDA Town Hall
203AB
10:30am •
#214: Product Management Strategies: Maximizing Content Re-Use to Meet Diverse Customer Information Needs
2:00pm •
#254: CBER Town Hall: State of the Center and Plans for the Future
4:00pm •
#265: Enabling Innovative New Endpoint Measurement Using Mobile Technology
204A
10:30am •
#222: Valuing the Clinical Trial Patient
2:00pm •
#244: Transforming Clinical Development Through Enterprise Quality Management
4:00pm •
#269: Making Quality Stick: Building a Complete Quality Culture
204B
10:30am •
#219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development
2:00pm •
#240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards
4:00pm •
#264: FDA Update on Data Standards
204C
10:30am •
#216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step
2:00pm •
#243: Patient Involvement Today and Tomorrow: What’s in It for Patients?
Ballroom A
8:00am •
#203: Next Generation Collaborations: Transforming the Industry
Exhibit Hall
9:30am •
Coffee Break
11:30am •
Luncheon
Exhibit Hall A
9:40am •
#205: It’s Not You; It’s Me: Dealing with Team Challenges, Critique, and Criticism
9:40am •
#204: Professional Poster Session and Oral Presentions 1A
10:45am •
#228: Increase Value of Clinical Trials Through Impactful Branding
12:00pm •
#231: Introduction to Structured Content
12:00pm •
#229: Professional Poster Session and Oral Presentions 1B
2:00pm •
#255B: Lost in Translation: The Importance of Data Presentation
4:00pm •
#278: Real Life Application of Risk-Based Monitoring
Exhibit Hall B
9:45am •
#206: Covance Innovation Theater: Leveraging Patient Data and Historical Investigator Performance Data to Realize Faster Patient Recruitment
12:00pm •
#230: Quintiles Innovation Theater: Transforming Patient Recruitment Through Site and Patient Engagement
12:40pm •
#232: PRA Innovation Theater: Transforming EMR to EDC
1:20pm •
#233: Veeva Innovation Theater: The Great RIM Throwdown! How Are You Managing Regulatory Events?
2:00pm •
#255A: DIA Innovation Theater: Special Session for Exhibitors: Global Trends in Drug Development and Opportunities with DIA Worldwide
3:25pm •
#256: Veeva Innovation Theater: 2016 Paperless TMF Survey: Trends and Insights
TBA
7:00am •
Attendee, Speaker, and Exhibitor Registration Open
7:00am •
Coffee and Light Refreshments
9:00am •
Exhibit Hall Open
1:30pm •
Exhibit Guest Passes
3:00pm •
Refreshment Break
TBD
9:00am •
Professional Poster Session 1
Wednesday
, June 29
102AB
10:30am •
#308: Patient Recruitment Workshop: Survey Results and Practical Application
2:00pm •
#352: From Mistakes to Success: Lessons Learned from Organizational Change Management Programs
4:00pm •
#358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages
103A
10:30am •
#326: FDA Rare Disease Town Hall
2:00pm •
#344: Companion Diagnostics: Driving New Business Models for Successful Outcomes
4:00pm •
#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?
103ABC
8:00am •
#301: The Future of Big Data
103C
10:30am •
#317: Global Medical Device Development: Regulatory Concordance or Discordance?
2:00pm •
#353: The Utility of Natural History Studies in Drug Development and Approval
4:00pm •
#376: Pediatric Rare Disease Drug Development
104A
9:45am •
Speaker Training Session
105AB
10:30am •
#309: Global Stakeholder Management: Across the Ocean Between East and West
2:00pm •
#336: Effect of International Reference Pricing on Planning for Global New Product Launches
4:00pm •
#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results
107AB
10:30am •
#322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence
2:00pm •
#348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC
4:00pm •
#370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices
108A
10:30am •
#307: Mythbusting Site Productivity: Referral Practices and Untapped Site Options
2:00pm •
#350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort?
4:00pm •
#374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations
108B
10:30am •
#310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch
2:00pm •
#351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies
4:00pm •
#357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects
109AB
10:30am •
#324: Implementing Adaptive Designs Involves Greater Teamwork
2:00pm •
#349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements
4:00pm •
#369: Innovative and Emerging Technologies
111AB
10:30am •
#311: Outsourcing: Assessing CRO Performance and Challenges
2:00pm •
#347: Global Harmonization: Non-ICH Regions
4:00pm •
#359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk
112AB
10:30am •
#325: Reinventing You: How to Change Your Career Fearlessly!
2:00pm •
#337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools
4:00pm •
#375: Creating Competent Clinical Research Professionals Through Systematic Evidence Review
113A
10:30am •
#323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation
2:00pm •
#333: Hearing the Patient Voice in Pharma and What Patients Want You to Know
4:00pm •
#371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety
113B
10:30am •
#321: Office of Pharmaceutical Quality Update
2:00pm •
#334: Risky Business: Latest Trends, Strategies, and Tools for Predicting Success and Monitoring Risk During Clinical Trial Operations
4:00pm •
#373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs
113C
10:30am •
#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
2:00pm •
#335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials
4:00pm •
#372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes
114
8:00am •
#302: Europe and the US: Making Outcomes-Based Health Care Possible
201A
10:30am •
#320: Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials
2:00pm •
#338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection
4:00pm •
#368: Conducting Trials in China
201B
10:30am •
#315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My!
2:00pm •
#343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape
4:00pm •
#363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines
201C
10:30am •
#327: FDA–Health Canada Regulatory Cooperation Council Town Hall
2:00pm •
#342: Big Data in Health Care and Life Sciences
202AB
10:30am •
#318: Changes to Common Rule Likely Affecting FDA-Governed Research
2:00pm •
#345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority?
4:00pm •
#366: Infectious Disease Containment and Lessons Learned
203AB
10:30am •
#314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End
2:00pm •
#339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them
4:00pm •
#361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep
204A
10:30am •
#319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development
2:00pm •
#346: Anticipating and Responding to Challenges in Issue Management
4:00pm •
#367: Quality at the Edge(s): Design It Right and Keep It Going in Non-Interventional Studies
204B
10:30am •
#313: The Future of Clinical Research Data: 2020 and Beyond
2:00pm •
#341: eTMF: Selection, Implementation, and What's Next?
4:00pm •
#364: Cell and Gene Therapies: Current Global Landscape
204C
10:30am •
#316: What’s Your Preference? The Emerging Importance of Patient Preference Elicitation
2:00pm •
#340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research
4:00pm •
#362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders
Ballroom A
8:00am •
#303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
Exhibit Hall
9:30am •
Coffee Break
11:30am •
Luncheon
Exhibit Hall A
9:40am •
#305: MedDRA: Use in the Review of New Drug Applications at the FDA
9:40am •
#304: Professional Poster Session and Oral Presentions 2A
10:45am •
#328: The Ethics of “Big Data” Biomedical Science
12:00pm •
#331: Applying Design Thinking to Clinical Development: Human-Centered Approaches to Improve Quality and Efficiency
12:00pm •
#329: Professional Poster Session and Oral Presentions 2B
2:00pm •
#354: Protocol Optimization: Making It Real
3:15pm •
#356: Let's Enjoy Global Stakeholder Management
Exhibit Hall B
9:45am •
#306: SAS/JMP Innovation Theater: Efficient Safety Assessment in Clinical Trials Using the Computer-Generated Adverse Event Narratives of JMP Clinical
12:00pm •
#330: SAS Innovation Theater: Empowering Action – Fueling Safety and Operational Efficiency
12:40pm •
#332A: Salesforce Innovation Theater: Connect to Your Patients, Providers, and Partners in a Whole New Way with the Salesforce Platform
1:20pm •
#332B: SAP Innovation Theater: Too Much R&D Data to Develop New Drugs and Medical Devices?
3:25pm •
#355: DBMS Consulting/Clinical Ink Innovation Theater: Safety Data Delay Is a Risk-Enhanced Signal Detection with Customized MedDRA and Drug Grouping Queries
TBA
7:00am •
Attendee, Speaker, and Exhibitor Registration Open
7:00am •
Coffee and Light Refreshments
9:00am •
Exhibit Hall Open
1:30pm •
Exhibit Guest Passes
3:00pm •
Refreshment Break
TBD
9:00am •
Professional Poster Session 2.
Thursday
, June 30
103ABC
9:00am •
#402: Protocol Development Is a Team Sport
107AB
10:45am •
#405: Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies
108A
10:45am •
#411: Nonclinical Statistics for Chemistry, Manufacturing, and Control: Case Studies and Regulatory Perspective
108B
10:45am •
#403: Running Personalized Medicine Trials: Facts and Figures
109AB
10:45am •
#408: Securing Internet-Driven Collaboration in Drug Development
111AB
10:45am •
#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
112AB
10:45am •
#404: Bringing CRO Collaboration into the 21st Century
113A
10:45am •
#406: Navigating Partnerships and Submissions: Best Practices for Successful Medical Writing Deliverables Involving Multiple Stakeholders
113B
10:45am •
#410: The Role of Big Data in Transforming the Detection of Adverse Drug Reactions
113C
10:45am •
#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment
114
9:00am •
#401: EMA/FDA Question Time
10:45am •
#412: CDER Town Hall
TBA
8:00am •
Coffee and Light Refreshments
8:00am •
Attendee and Speaker Registration
10:30am •
Coffee Break
Timezone
DIA 2016 Annual Meeting
America/New York
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DIA 2016 Annual Meeting
Jun 25
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30, 2016
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Design Thinking
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Increasing Research and Development Innovation
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Labeling
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Val - Electronic Info Integrity
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Dates
Saturday
, June 25
Sunday
, June 26
Monday
, June 27
Tuesday
, June 28
Wednesday
, June 29
Thursday
, June 30
Venue
102AB
103A
103ABC
103C
104A
104AB
105AB
107AB
108A
108B
109AB
111AB
112AB
113A
113B
113C
114
201A
201B
201C
202AB
203AB
204A
204B
204C
Ballroom A
Ballroom AB
Exhibit Hall
Exhibit Hall A
Exhibit Hall B
Liberty Ballroom A
TBA
TBD
Session Type
Preconference Tutorial
All
Tutorial
Trk 01: Clinical Operations
All
Forum
Session
Symposium
Tutorial
Workshop
Trk 02: Proj-Port Mgt-Strat Planning
All
Forum
Session
Workshop
Trk 02: Proj/Port Mgt/Strat Planning
All
Forum
Trk 03: Innov Part Model-Outsourcing
All
Forum
Session
Symposium
Trk 03: Innov Part Model/Outsourcing
All
Session
Trk 04: Preclin Transl-Early Clin Dev
All
Forum
Session
Symposium
Trk 05: Reg of Prod Adv-Mkting
All
Forum
Session
Trk 05: Reg of Prod Adv/Mkting
All
Forum
Session
Trk 06: Med Comm-Wrtg-MSL
All
Session
Symposium
Trk 06: Med Comm/Wrtg/MSL
All
Session
Trk 07: Tech-Data- Records-Subs
All
Forum
Session
Symposium
Trk 07: Tech/Data/ Records/Subs
All
Forum
Session
Symposium
Trk 08: Reg Affairs
All
Forum
Session
Tutorial
Trk 09: Med Devices-InVitro-CombProd
All
Forum
Session
Trk 09: Med Devices/InVitro/CombProd
All
Session
Trk 10: Pub Pol-HealthCare Compl-Law
All
Forum
Session
Tutorial
Trk 10: Pub Pol/HealthCare Compl/Law
All
Forum
Session
Trk 11: Quality in CT-GCP
All
Forum
Session
Tutorial
Trk 11: Quality in CT/GCP
All
Session
Trk 12: Pharm Quality
All
Forum
Session
Trk 13: CER-Glob Health Econ
All
Forum
Session
Tutorial
Trk 13: CER/Glob Health Econ
All
Forum
Session
Trk 14: Clin Safety-PV
All
Forum
Session
Tutorial
Trk 14: Clin Safety/PV
All
Session
Trk 15: Statistics
All
Forum
Session
Tutorial
Trk 16: Prof Development
All
Forum
Session
Tutorial
Workshop
Trk 17: Rare-Orphan Diseases
All
Forum
Session
Symposium
Tutorial
Trk 17: Rare/Orphan Diseases
All
Session
Trk 18: Global Regulatory
All
Forum
Session
Trk 19: DIAmond
All
Forum
Trk 20: Innov Theater
All
Session
Trk 21: Poster Presentations
All
Poster Presentation
Trk 22: Engage and Exchange
All
Workshop
Trk 23: Opening Plenary
All
Session
Other Filters
Credit Type
ACPE
CME
IACET
PMI
RN
Audience
Advanced
Basic
Intermediate
Featured Topics
21st Century Cures
Agency Participation
Approval Pathways
Audits and Inspections
Benefit-Risk
Big Data
Biologics-Biosimilars
Clinical Trial Designs
Clinical Trial Transparency-Clinical Trial Disclos
Cloud Computing
Community-led-Scientific Working Group Offerings
Current Issues in Policy and Law
Design Thinking
Disease Specific
Disruptive Technologies
Electronic Health Records (EHR)
Emerging Markets
GDUFA-Generics
Hot Topics in Policy and Law
IDMP
Increasing Research and Development Innovation
Interactive Workshop
Labeling
Mobile-Wearable Technology
Observational Studies
Partnership Strategies
Patient Engagement
Patient Recruitment and Retention
Patient Registries
Pediatrics
Precision-Personalized Medicine-Targeted Therapy
Pricing- Reimbursement and Access
Program Offerings for Student Attendees
R&D Innovation
Regulatory Harmonization-Convergence
Risk Evaluation and Mitigation Strategies (REMS)
Risk-Based Monitoring
Social Media Strategies
Topics Related to Asia-Pacific Region
Topics Related to Canada
Topics Related to China
Topics Related to Europe-EMEA
Topics Related to India
Topics Related to Japan
Vaccines
Value-Based Evidence
Women's Health
Interest Area
Academic Health Centers-Investigative Sites
Advertising & Promotion
Biotechnology
Clinical Data Management
Clinical Data Management - eClinical
Clinical Research
Clinical Safety & Pharmacovigilance
Clinical Supplies
CMC
CMC-GMP
Combination Products
Comparative Effectiveness
Document & Records Management
eClinical
Finance
Good Clinical Practices & QA
Information Technology
Manufacturing
Marketing & Sales
Medical Communications
Medical Devices & Diagnostics
Medical Science Liaison
Medical Writing
Non-clinical Safety
Outsourcing
Patient Engagement
Pharmaceutics
Pricing - Reimbursement
Professional Education - Training & Development
Project Management
Public Policy - Health Care Compliance - Law
Public Policy - Law
QA-QC
Quality Assurance - Quality Control
R&D - Strategic Issues
Rare - Orphan Diseases
Regulatory Affairs
Statistics
Strategic Planning
Study Endpoints
Submissions
Val - Electronic Info Integrity
Popular