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01: Data-BigData-eHealth
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02: DisruptiveInnov
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03: MedAffairs-SciComm
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04: PatientEngagement
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05: Regulatory
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06: Safety-PV
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07: SpecialPops
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08: StratPlan-Exec-Partnershps
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09: TranslSci-Preclin-Clin-ProdDev
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10: Value-Access
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11: Quality
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12: DIAmond
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13: InnovTheater
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14: ProfDevelopment
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15:Engage-Exchange
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16: Posters
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17: ContentHub
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18: Plenary
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19: DIACommunities
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Career Development
Clinical Operations
Data Management
Devices-Combination Products
Electronic Regulatory Submissions
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Medical Writing
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Public Policy
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Saturday
, June 17
TBA
8:00am •
Exhibitor Registration
Sunday
, June 18
Hyatt Regency McCormick Place, Regency Ballroom
12:00pm •
DIA Drug Development and Life Sciences Career Fair: Career Fair Expo
N426a
2:45pm •
#001: To Change or Not to Change, That is the Career Question: Knowing When it’s Time to Move On (Not, Run From)
4:15pm •
#002: Networking Within Your Company
Prairie Room, Hyatt
10:30am •
Student Session
S401a
8:30am •
#20: Leadership: How to Organize and Lead People in a Work Group
1:00pm •
#30: Preparing for a US FDA Advisory Committee Meeting
S401bc
8:30am •
#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing
S401d
8:30am •
#22: How to Prepare for an FDA Inspection
1:00pm •
#32: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
S402ab
8:30am •
#23: Signal Detection: Identifying and Managing Safety Signals
1:00pm •
#34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
S403ab
8:30am •
#24: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
1:00pm •
#31: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation
S404a
8:30am •
#25: Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China
1:00pm •
#35: Digital Health Technologies for Combination Products and Beyond: Development and Regulation
S404bc
8:30am •
#26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm
1:00pm •
#33: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
S404d
9:00am •
#40: Clinical Statistics for Nonstatisticians
S405a
9:00am •
#42: Analysis of Safety Data from Clinical Trials
S405b
9:00am •
#43: The Good Pharmacovigilance Practices in the EU: Global Applications
TBA
8:00am •
Registration for Full Day and Morning Preconference Short Courses
8:00am •
Exhibitor Registration
8:30am •
Half Day Morning Preconference Short Courses
9:00am •
Full Day Preconference Short Courses
12:30pm •
Registration for Afternoon Preconference Short Courses, Conference Attendees, and Speakers
1:00pm •
Half Day Afternoon Preconference Short Courses
Monday
, June 19
Arie Crown Theater
3:00pm •
#142: Opening Remarks and Keynote Address
Community Corner
12:30pm •
DIA Patient Engagement Community Round Table Discussion: The Future of Patient Engagement: Measuring What Matters
1:45pm •
DIA Medical Writing Community Round Table Discussion: Submission Dossiers: Communications Excellence to Drive Speed and Quality
Exh Hall
12:30pm •
#134: Student Poster Session and Oral Presentations 1A
4:45pm •
#146: Student Poster Session and Oral Presentations 1B
Exhibit Hall
11:00am •
#129: Engage and Exchange Student Forum
1:15pm •
#137: The Worst Coworker on the Block: Can YOU Work with Difficult People? Yes, You Can!
Hyatt Regency McCormick Place, Regency Ballroom
1:00pm •
DIA Drug Development and Life Sciences Career Fair: Private Interviews
N226
11:00am •
#126: Breaking Down the Wall for FDA to Leverage Real World Data
N227b
11:00am •
#120: FDA Rare Disease Town Hall
N228
11:00am •
#114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI
N229
11:00am •
#106: Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research From Sponsor, Vendor and National Health System Perspective: Case Studies
N230b
11:00am •
#128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment
N426a
11:00am •
#111: Patient Engagement: 4 W's and an H
N426b
11:00am •
#112: Data Sharing: 2017 and Beyond
N426c
11:00am •
#113: We Can't Forget the Children in This Process
Poster Area Exhibit Hall
12:30pm •
Student Poster Session
S100a
8:30am •
#102: The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making
S100c
8:30am •
#103: The Future of Patient Engagement: Measuring What Matters
S105
8:30am •
#101: Drug Repurposing: Where Will it Take Us?
S400 Concourse
11:00am •
#130: Career Opportunities in Transitions in Life Science
11:45am •
#131: A Day in the Life of A....
1:15pm •
#138: Day in the Life of A…Part 2
S401a
11:00am •
#117: Postmarketing Safety Studies: Approaches and Regulatory Insights
S401bc
11:00am •
#119: Designing and Implementing a Robust Pharmacovigilance System for Vaccines
S401d
11:00am •
#118: Counting on Safety
S402ab
11:00am •
#124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies
S403ab
11:00am •
#115: Update from the CFDA
S404a
11:00am •
#122: GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial
S404bc
11:00am •
#125: Hybrid Study Designs: An Innovative Approach to Obtaining Valuable Information by Combining Existing Data with New Data Length
S405a
11:00am •
#127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India
S405b
11:00am •
#123: Calling All Angels to the Valley of Death
S501abc
11:00am •
#107: Leveraging Wearables and Sensors in Clinical Trials and mHealth
S502ab
11:00am •
#108: Artificial Intelligence/Machine Learning
S503ab
11:00am •
#109: Submission Dossiers: Communications Excellence to Drive Speed and Quality
S504abc
11:00am •
#110: Globalization of Medical Affairs Departments
S505ab
11:00am •
#121: Effective Life Cycle Management
TBA
6:30am •
CISCRP Medical Appreciation 5K
7:00am •
Attendee, Speaker, and Exhibitor Registration
7:30am •
Coffee and Light Refreshments
7:30am •
Annual Meeting Orientation
10:00am •
Exhibit Hall Open
10:00am •
Coffee Break
12:00pm •
Luncheon
4:30pm •
Opening Reception
Theater #1
10:15am •
#105: DBMS Consulting Innovation Theater: Replacing dsNavigator with Oracle TMS as a centralized coding solution
12:30pm •
#133: Tata Consultancy Services Innovation Theater: Global Regulatory Information Portal (GRIP) – A Regulatory Information Strategic Effectiveness Portal
1:15pm •
#135: PAREXEL International Innovation Theater: Developing Drugs in the New Era of Personalized Medicines
2:00pm •
#139: Deloitte Consulting Innovation Theater: 21st Century Cures and Person-Centered Research: A Recipe for Innovation
4:45pm •
#143: Advanced Clinical Innovation Theater: Avoid Systems Overload: Connecting and Operationalizing Disparate Technology Systems Supporting Clinical Trials
5:30pm •
#148: DBMS Consulting Innovation Theater: Manage Customized SMQs/MedDRA Queries and Customized SDGs/Drug Groupings and Facilitate Risk Profiling and Safety Analysis with OpenCQT
Theater #2
10:15am •
#104: Cenduit LLC Innovation Theater: High-Profile Early Onset Alzheimer’s Disease Study in an Academic Setting Requiring Highly Configurable IRT System for Complex Study Design.
12:30pm •
#132: QuintilesIMS Innovation Theater: The Next Generation of Clinical Development is Here
1:15pm •
#136: Covance Innovation Theater: Lessons Learned From Deploying Clinical Data Review: Ensuring Patient Safety, Increasing Operational Efficiency and Creating New Insights
2:00pm •
#140: SAS Institute Inc. Innovation Theater: Clinical Analytics Workflow Optimization
4:45pm •
#145: Educational Measures Innovation Theater: EM Array™ Live Meeting Technology
5:30pm •
#147: Appian Innovation Theater: Product Lifecycle Management In The Digital Era
Tuesday
, June 20
Community Corner
10:30am •
DIA Study Endpoints Community Round Table Discussion: Leveraging Wearables and Sensors in the Clinical Trials and mHealth
1:00pm •
DIA Patient Engagement Community Round Table Discussion: Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What Have We Learned?
2:00pm •
DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches
Exh Hall
9:30am •
#205: Professional Poster Session 2A
12:00pm •
#236: Professional Poster Session and Oral Presentions 2B
Exhibit Hall
9:30am •
#204: Effective Team Management in Global Trials
10:45am •
#232: Healthy CRO/Sponsor Relations: “Sole” Mate or Flavor of the Month
12:45pm •
#237: Strategies for Communicating with FDA
2:00pm •
#263: Mergers and Acquisitions: Due Diligence Considerations
4:00pm •
#291: Combination Products
N139
5:30pm •
DIA Study Endpoints Community Meeting
N226
10:30am •
#208: Big Data: Regulatory Information
2:00pm •
#251: Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory
4:00pm •
#269: Big Data: Genomics and Personalized Medicine
N227b
10:30am •
#214: Recent Trends in Asian Regulations for Drug Development: What is Coming Next?
2:00pm •
#242: Big Data: Current and Emerging Technologies
4:00pm •
#268: FDA Session: Health IT at FDA
N228
10:30am •
#209: Evolving Data Standards and Regulations
2:00pm •
#241: FDA Session: Electronic Submissions and Data
4:00pm •
#277: The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry
N229
10:30am •
#216: International Collaboration in Times of Public Health Crisis
2:00pm •
#261: Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in Support of Marketing Applications of New Drug Products to EMA and FDA
4:00pm •
#290: Quality Metrics: The Carrot or the Stick?
N230b
10:30am •
#221: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches
2:00pm •
#256: Post-Trial Access: Ensuring Patient Access Across the Development Spectrum
4:00pm •
#288: Breaking Down the Wall for Global Regulators to Leverage Real World Data
N426a
10:30am •
#212: Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What Have We Learned?
12:45pm •
PowerUp!
2:00pm •
#243: Data and Privacy Protection
4:00pm •
#270: Data Quality
N426b
10:30am •
#211: Sharing the Burden
2:00pm •
#257: Strategic Planning Across Research Organizations
4:00pm •
#283: The Impact of Industry Consortia on Creating Collaborative Solutions to Drug Development Challenges: What Does the Future Hold?
N426c
10:30am •
#229: Outcomes Standardization: An Imperative to Value Assessments
2:00pm •
#240: Mobile Health: Participatory Research
4:00pm •
#289: Value and Access for Special Populations: From Access Restriction to Drug Mortgages
N427bc
12:00pm •
DIA Communities Luncheon
Poster Area Exhibit Hall
9:30am •
Professional Poster Session 1
S100a
8:00am •
#203: Radical Technologies: Changing the Future of Biopharmaceuticals
S100c
8:00am •
#202: People Will Talk: Gathering Insights from Digital Listening
S105
8:00am •
#201: Paying for Value in Biopharmaceuticals: Trends in the United States
S400 Concourse
10:30am •
#231: A Risk-Based Approach to Quality Management for RWE Studies
1:15pm •
#239B: Strategies for Managing Difficult Stakeholders
2:45pm •
#265: Patient Engagement in Study Endpoints: Will the Rising Tide Lift All Boats?
4:00pm •
#292: How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies
4:45pm •
#293: Conversations That Matter: How do Regulatory Affairs Professionals Wish to Engage with Statisticians and Vice Versa?
S401a
10:30am •
#219: Safety Evaluation: Transforming Information into Evidence
2:00pm •
#248: Building the Medical Strategy and Tactics
4:00pm •
#284: Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More
S401bc
10:30am •
#220: Cardiac Safety
2:00pm •
#262: Clinical Relevant Specifications: Leveraging Principles of QbD
4:00pm •
#280: Developing Pharmacovigilance Policy Based on Impact
S401d
10:30am •
#210: The New Business Reality for the Medical Science Liaison Community
2:00pm •
#250: If You See Something (About a Clinical Trial), Do You Say Something (to Your Doctor?)
4:00pm •
#275: Partnering with Patients: Virtual and Traditional Communities - When for What
S402ab
10:30am •
#230: Global Harmonization: Mutual Recognition
2:00pm •
#249: Not Your Grandma's Patient Advocacy Group Anymore
4:00pm •
#276: Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools
S403ab
10:30am •
#213: Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?
2:00pm •
#254: New Considerations in Benefit-Risk Management
4:00pm •
#274: Effective Collaboration Between Sponsors and Medical Writing Vendors
S404a
10:30am •
#217: Update from CBER: Advancing the Development of Complex Biologic Products
2:00pm •
#252: What’s New in Devices: European Medical Device Regulations and MDUFA IV
4:00pm •
#278: PMDA Town Hall
S404bc
10:30am •
#218: ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act
2:00pm •
#253: Regulatory Challenges with Next Generation Sequencing
4:00pm •
#279: Brexit: Where Are We Now?
S404d
10:30am •
#215: The Evolving Model of Using Artificial Intelligence to Deliver Actionable Regulatory Intelligence
2:00pm •
#258: Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2
4:00pm •
#287: Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2
S405a
10:30am •
#228: Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development
2:00pm •
#259: Novel Techniques for Improving Clinical Trial Subject Retention
4:00pm •
#285: What Question Are You Trying to Answer? The Use of Estimands, Potential Revisions to ICH E-9 and the Impact to Trial Design and Analysis
S405b
10:30am •
#227: At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints
2:00pm •
#260: Comparative Effectiveness: State of the Art and Stakeholder Perspectives
4:00pm •
#286: Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In...
S501abc
10:30am •
#225: So You Say You're an Extrovert: Being an Effective Leader when All You Really Want Is a Stage
2:00pm •
#244: New Trial Design Approaches: Including New Endpoints
4:00pm •
#271: Next Generation Patient Recruitment: Part 1 of 2
S502ab
10:30am •
#226: Accelerating Drug Development Through Innovation
2:00pm •
#245: Leveraging Wearables and Sensors in Clinical Trials: Case Studies
4:00pm •
#272: Microbiome: Innovative Therapeutics, Challenges, and Opportunities
S503ab
10:30am •
#223: Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol Development, and Operations Perspective
2:00pm •
#246: Medical Information and the Patient: Effective Communication and Handling of Requests
4:00pm •
#273: Creating Adaptive Contents for a Multichannel World
S504abc
10:30am •
#224: Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with Biomarkers
2:00pm •
#247: Best Practice for Advisory Committee Meeting Preparation
4:00pm •
#282: Challenges and Issues in Early-Phase Oncology Trials
S505ab
10:30am •
#222: Serving the Patient Who Needs Early Access to Treatments and Achieving Meaningful Outcomes
2:00pm •
#255: Integrating the Patient's Voice Across the Development Program of Rare Diseases: Translation Into Meaningful Outcomes
4:00pm •
#281: Integrating the Patient's Voice Across the Development Program of Rare Diseases: At the Table - Where to Sit?
TBA
7:00am •
Coffee and Light Refreshments
7:00am •
Attendee, Speaker, and Exhibitor Registration
9:30am •
Coffee Break
9:30am •
Exhibit Hall Opens
11:30am •
Luncheon
1:30pm •
Exhibit Guest Passes
3:00pm •
Refreshment Break
Theater #1
9:45am •
#207: Veeva Systems, Inc. Innovation Theater: 2017 Unified Clinical Operations Survey
12:00pm •
#235: Amplexor Innovation Theater: Reduce Complexity – Increase Compliance – Decrease TCO’s: Regulatory Vendor Promises - Innovations or Buzzwords?
1:00pm •
#238: Veeva Systems, Inc. Innovation Theater: Tomorrow's Clinical Trial, Powered by Modern EDC
3:25pm •
#267: Veeva Systems, Inc. Innovation Theater: Unified RIM: End-to-end Submissions Development—from Planning Through Archival
Theater #2
9:45am •
#206: Covance Innovation Theater: Overcoming Study Complexity Through Data-Driven Design
12:00pm •
#234: QuintilesIMS Innovation Theater: Changing Trials Through Analytics: How it Works
1:00pm •
#239A: BioClinica Innovation Theater: Case Studies: How Companies Are Finally Reaping the Benefits of Risk-Based Monitoring.
3:25pm •
#266: BBK Worldwide Innovation Theater: Building a Patient-Centric Mindset through Theatrical Contemplation
Wednesday
, June 21
Aisle 300/400
9:30am •
#304: Mergers and Acquisitions: First, Do No Harm
10:45am •
#332: Patient Perspective
12:45pm •
#335: Real-World Application of Risk-Based Monitoring
2:00pm •
#359: Cultural Diversity
3:15pm •
#362: Medical Affairs and KOL Management
Community Corner
12:00pm •
DIA Patient Engagement Community Round Table Discussion: Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness
1:00pm •
DIA Regulatory Affairs Community, Regulatory Intelligence WG Round Table Discussion: The Evolving Role of Using Artificial Intelligence to Deliver Actionable Intelligence
4:00pm •
DIA Medical Writing Community Round Table Discussion: EMA Policy 0070:A Game Changer for Industry
Exh Hall
9:30am •
#305: Professional Poster Session 3A
12:00pm •
#334A: Professional Poster Session and Oral Presentions 3B
N139
5:30pm •
DIA Clinical Safety and Pharmacovigilance Community Meeting
N226
10:30am •
#320: The Brave New World: The Ongoing Globalization of Pharmacovigilance
2:00pm •
#338: Risk-Based Monitoring: Convergence of Technology, Processes, and People
4:00pm •
#364: Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion
N227b
10:30am •
#308: Quantified Self Tracking
2:00pm •
#341: EMA Policy 0070: A Game Changer for Industry
4:00pm •
#368: FDA Update on Prescription Drug Promotion
N228
10:30am •
#312: CRISPR: Regulatory Challenges in the Gene Editing Revolution
2:00pm •
#345: Global Perspective on ICH: Part 1 of 2
4:00pm •
#374: Global Perspective on ICH: Part 2 of 2
N229
10:30am •
#310: New Site Paradigm: Just in Time Sites
2:00pm •
#339: Off-Label Communications to Health Care Providers and Consumers
4:00pm •
#372: The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator
N230b
10:30am •
#328: Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness
2:00pm •
#343: Expanded Access and Compassionate Use
4:00pm •
#363: EHRs/eSource and Emerging Data Streams
N426a
10:30am •
#316: Quantitative Metrics to Capture the Value of Patient Engagement
2:00pm •
#337: Big Data: Management and Analytics
4:00pm •
#380: Effective Portfolio Management and How to Ensure You Get the Value Out of the Decisions Made
N426b
10:30am •
#323: Effective Collaborations: Navigating the Grey Space
2:00pm •
#346: Understanding the New Common Rule and Its Impact to Industry
4:00pm •
#381: Maximizing Success in Partner Collaborations
N426c
10:30am •
#324: Keys to Effective Product Launch Preparation
2:00pm •
#342: Adoption and Implementation of Digital Platforms to Further Patient Interactions
4:00pm •
#385: Patient-Centric Development Assessment
Poster Area Exhibit Hall
9:30am •
Professional Poster Session 2
S100a
8:00am •
#303: International Regulatory Convergence
S100c
8:00am •
#302: Does Diversity Matter in Clinical Trials?
S105
8:00am •
#301: Progress in Pediatric Therapeutics
S400 Concourse
10:30am •
#331: Conversations that Matter: How do Pharmacovigilance Professionals wish to Engage with Statisticians and Vice Versa?
11:15am •
#333: Information Quality in EHR Computer Systems
2:45pm •
#361: Online Health Communities: A New Frontier in Health Research
S401a
10:30am •
#326: Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation
2:00pm •
#340: Digital Innovations for Medical Information Contact Centers
4:00pm •
#384: The Increasing Role for Big Data for Late Phase Drug and Postapproval Purposes
S401bc
10:30am •
#325: Leading in the Midst of Ambiguity
2:00pm •
#353: What Do the Experts Believe? Translating Expert Knowledge and Judgment Into a Quantitative Belief Distribution
4:00pm •
#379: The Art of Negotiation: Preparing Yourself and Your Team for Their Seat at the Table
S401d
10:30am •
#314: Digital Channels and Artificial Intelligence in Medical Information and Communications
2:00pm •
#347: Integrated Life Cycle Approaches to Benefit -Risk Assessment, Communication, and Evaluation
4:00pm •
#373: FDA–Health Canada Regulatory Cooperation Council Town Hall
S402ab
10:30am •
#327: Multiregional Clinical Trials and the ICH E17
2:00pm •
#348: Exploring the Evolution of Signal Detection
4:00pm •
#375: Automation and Innovation in Clinical Trial Safety Assessment
S403ab
10:30am •
#315: How to Engage Patients Within Medical Affairs
2:00pm •
#349: Pharmacovigilance 2.0: Redesigning for the Future
4:00pm •
#371: Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies
S404a
10:30am •
#318: IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System
2:00pm •
#344: Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval
4:00pm •
#369: How Is Digital Patient Engagement Impacting Trial Participation?
S404bc
10:30am •
#317: Evolution of Novel Registration Endpoints as Diseases Become Chronic
2:00pm •
#355: FDA, NIH, and TransCelerate Collaborate to Accelerate Drug Development Through Protocol Harmonization
4:00pm •
#370: Lessons Learned from the Sarepta Exondys 51 Approval
S404d
10:30am •
#319: A New Age for Physician and Patient Labeling: Recommendations for Innovative Change in How We Communicate
2:00pm •
#358: Life Cycle Management: ICH Q12
4:00pm •
#376: Changing Environments Within Pharmacovigilance
S405a
10:30am •
#329: Measuring and Advancing the Clinical Quality Management System
2:00pm •
#354: Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision Making
4:00pm •
#382: Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It
S405b
10:30am •
#330: Managing Acceleration and Quality In Product Development
2:00pm •
#357: Biosimilars and Generics: Access Versus Innovation
4:00pm •
#383: Safety Issues in First-in-Human Studies
S501abc
10:30am •
#311: Next Generation Patient Recruitment: Part 2 of 2
2:00pm •
#351: Pregnancy and Lactation Labeling Rule: Unique Challenges to Meet Requirements
4:00pm •
#378: Looking to the Future for EU Pediatric Investigation Plans
S502ab
10:30am •
#313: New Frontiers in Pharmaceutical Manufacturing
2:00pm •
#350: Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric Indications
4:00pm •
#367: Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and Its Impact on Global Pharmaceutical Activities
S503ab
10:30am •
#321: Engagement, Education, Networks, Media, and Societies in Rare Diseases: The MUST Haves
2:00pm •
#356: Value-Based Conversations with Payers: Issues, Opportunities, and Barriers
4:00pm •
#365: Next Generation Predictive Analytics
S504abc
10:30am •
#322: Is the Future Bright for Treatment of Neurodegenerative Diseases?
2:00pm •
#352: Collaborative Efforts to Accelerate Rare Disease Research and Development
4:00pm •
#366: Are We Ready for Telemedicine-Powered Clinical Trials?
S505ab
10:30am •
#309: Big Data: Combining Registries and Legacy Clinical Trial Databases
4:00pm •
#377: Increasing Participation in Clinical Trials Among Under-Represented Populations
TBA
7:00am •
Coffee and Light Refreshments
7:00am •
Attendee, Speaker, and Exhibitor Registration
9:30am •
Exhibit Hall Opens
9:30am •
Coffee Break
11:30am •
Luncheon
1:30pm •
Exhibit Guest Passes
3:00pm •
Refreshment Break
Theater #1
9:45am •
#306: Synchronoss Innovation Theater: Applying Telecom’s Mobility Best Practices to mHealth
12:00pm •
#334B: Cognizant Technology Solutions Innovation Theater: The Shared Investor Platform - An Innovative Open Technology Powering New possibilities for Site -Sponsor Relationship
Theater #2
9:45am •
#307: SAS Institute Inc, JMP Division, Innovation Theater: Work with Me Here...(or There or Anywhere!): Practical Cloud Collaboration with JMP Clinical
12:00pm •
#334C: Accenture Innovation Theater: The Digital Clinical Trial – Placing the Right Bets
1:00pm •
#336: QuintilesIMS Innovation Theater: Connecting People and Trials Through Innovative Technologies
Thursday
, June 22
N426b
10:45am •
#404: How Do You Build a Collaborative Community? What Advice Would You Give?
N426c
10:45am •
#405: How Do We Retain Patients in Studies? Using the Patients’ Words to Explore Treatment Acceptance and Patient Engagement
S105
9:00am •
#401: FDA Forum
10:45am •
#412: EMA/ FDA Question Time
S401a
10:45am •
#406: Recruiting Rare Disease Patients: A Unique Set of Challenges
S401d
10:45am •
#407: Exploration of Metabolic Diseases: Is the Liver the New Heart?
S402ab
10:45am •
#409: Trial Master File: MHRA/EMA Inspections and Sponsor Audit Learnings
S403ab
10:45am •
#403: Driving International Awareness and Use of Regulatory Writing Guidelines: Case Studies of the Clarity and Openness in Reporting (CORE) Reference Guidelines
S404a
10:45am •
#402: Online Patient Networking
S404d
10:45am •
#408: Flexing Your Project Management Muscles Outside of Traditional Roles
S405a
10:45am •
#410: Of Course My Data Has Integrity … And I Can Prove It
S405b
10:45am •
#411: Evolving Clinical Trial Guidance and Regulations: Am I Ready?
TBA
8:00am •
Attendee and Speaker Registration
8:00am •
Coffee and Light Refreshments
10:30am •
Coffee Break
Timezone
DIA 2017 Annual Meeting
America/Chicago
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DIA 2017 Annual Meeting
Jun 17
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22, 2017
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Aisle 300/400
Arie Crown Theater
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Hyatt Regency McCormick Place, Regency Ballroom
N139
N226
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Dates
Saturday
, June 17
Sunday
, June 18
Monday
, June 19
Tuesday
, June 20
Wednesday
, June 21
Thursday
, June 22
Venue
Aisle 300/400
Arie Crown Theater
Community Corner
Exh Hall
Exhibit Hall
Hyatt Regency McCormick Place, Regency Ballroom
N139
N226
N227b
N228
N229
N230b
N426a
N426b
N426c
N427bc
Poster Area Exhibit Hall
Prairie Room, Hyatt
S100a
S100c
S105
S400 Concourse
S401a
S401bc
S401d
S402ab
S403ab
S404a
S404bc
S404d
S405a
S405b
S501abc
S502ab
S503ab
S504abc
S505ab
TBA
Theater #1
Theater #2
Session Type
01: Data-BigData-eHealth
All
Forum
Session
Tutorial
02: DisruptiveInnov
All
Forum
Session
03: MedAffairs-SciComm
All
Forum
Session
Tutorial
04: PatientEngagement
All
Forum
Session
05: Regulatory
All
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06: Safety-PV
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07: SpecialPops
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08: StratPlan-Exec-Partnershps
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Workshop
09: TranslSci-Preclin-Clin-ProdDev
All
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Session
Tutorial
Workshop
10: Value-Access
All
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Session
11: Quality
All
Forum
Session
Tutorial
12: DIAmond
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Forum
Session
13: InnovTheater
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Session
14: ProfDevelopment
All
Session
Tutorial
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15:Engage-Exchange
All
Session
16: Posters
All
Poster Presentation
17: ContentHub
All
Session
18: Plenary
All
Session
19: DIACommunities
All
Session
Short Course
All
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Advanced
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Featured Topics
Academic Clinical Researcher
Career Development
Clinical Operations
Data Management
Devices-Combination Products
Electronic Regulatory Submissions
Global Regulatory
Medical Writing
Outsourcing
Patient Centric
Pediatrics
Public Policy
Quality-GXP
Rare Disease
RBM
Real World Evidence
Statistics
Wearables-Mobile Health
Popular