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00: Plenary
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01: ClinSafety-PV
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Tutorial
Workshop
02: ClinTrials -ClinOps
All
Forum
Session
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Workshop
03: Data-Data Standards
All
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Session
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Workshop
04: MedAffairs-SciComm
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Session
Tutorial
05: Patient Engagement
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Session
Tutorial
Workshop
06: PreClin Dev-EarlyPhaseCR
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Session
Tutorial
07: ProjMgt-StrategicPlanning
All
Forum
Session
Workshop
08: R-D Quality-Compliance
All
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Session
Tutorial
Workshop
09: Regulatory
All
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Session
Tutorial
Workshop
10: RegCMC-Product Quality
All
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Session
Tutorial
Workshop
11: Statistics
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Session
Tutorial
Workshop
12: Value-Access
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Session
Workshop
13: ProfDevelopment
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14: DIAmond
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15: Engage-Exchange
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16: Content Hubs
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17: Community Rounds
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18: InnovTheater
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19: Posters
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Poster Presentation
Networking-CommunityEvents
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Social Event
Short Course
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Level
Advanced
Beginner
Intermediate
Featured Topics
Advanced Therapies
Artificial Intelligence
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Patient Focused
Precision Medicine
Rare Disease
Real World Evidence
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Wednesday
, June 26
Community Area Sails Pav
10:30am •
DIAlogue Session 3: From My Crazy Career Path to Inside the Industry and How I Ended Up Here!
2:00pm •
#375.1 RT: Round Table Discussion: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
3:15pm •
#376.1 RT: Round Table Discussion: Master Protocols: Applications in Oncology
Community Zone Sails Pav
9:30am •
#322 RT: Round Table Discussion: Real World Data to Real World Evidence
9:30am •
#323 RT: Round Table Discussion: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?
12:45pm •
#351 RT: Round Table Discussion: An Industry Collaboration on Pharmacovigilance Analytics
12:45pm •
#352 RT: Round Table Discussion: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients
2:00pm •
#375 RT: Round Table Discussion: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?
3:15pm •
#377 RT: Round Table Discussion: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance
4:30pm •
#398 RT: Round Table Discussion: Digital Risk Minimization: The “Next Generation” Risk Management Tools
Content Hub Sails Pav
7:30am •
Talent Show
9:15am •
#320 CH: Considering Consulting? The Good, the Bad, the Ugly, and the Profitable!
10:00am •
#326 CH: 2020 and Beyond, Data Capture Across Systems, Functions, and Modalities
12:30pm •
#348 CH: Project Managing Your Own Leadership Journey
1:15pm •
#353 CH: The Current and Future State of RIM
2:00pm •
#373 CH: Success in the Workplace: What Does That Mean and How Can You Achieve it?
3:30pm •
#378 CH: Measuring “Value” in Value-Based Healthcare: A Health Economics Perspective
E and E Area Exh Hall
9:30am •
#321 EE: One Size Does NOT Fit All: Know How to Adapt your Communication Style to be Effective Communicating Up, Down and Peer-to-Peer
12:30pm •
#349 EE: Regulatory Affairs Governance: Benchmarking and Sharing of Best Practices
2:00pm •
#374 EE: Enabling Patient-Centric Clinical Studies: TransCelerate’s Patient Engagement Tools
3:15pm •
#376 EE: Assessing Medical Adherence in a Clinical Trial Setting: Challenges and Solutions
Exhibit Hall
9:15am •
Coffee Break
11:30am •
Luncheon Service
3:15pm •
Refreshment Break
Posters Exhibit Hall
9:00am •
Professional Poster Session 2
Room 10
8:00am •
#304: Operationalizing Master Protocols
10:30am •
#329: Global Clinical Trials: Make Them Really Global and Involve Africa
2:00pm •
#359: Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients
4:15pm •
#381: A New Path Forward for Using Decentralized Clinical Trials
Room 11A
8:00am •
#303: Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables
10:30am •
#330: The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations
2:00pm •
#357: Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite
Room 11B
8:00am •
#317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data
10:30am •
#331: A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock
4:15pm •
#394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials
Room 14A
8:00am •
#312: Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4)
10:30am •
#345: Achieving High Performance Through Emotional Intelligence
4:15pm •
#397: PowerUp: Stories of Career Transforming Moments
Room 14B
8:00am •
#318: Opportunities and Challenges of Collecting Data in a Pre-Approval Access Setting: A Multi-Stakeholder Perspective
10:30am •
#335: Highlights of the Patient Engagement Preparedness, Capabilities, Experience, and Impact (PEPCEI) Study
2:00pm •
#372: Advancing Value and Access With Technology
4:15pm •
#396: Challenges to Access: Bringing Payers to the Table
Room 15AB
8:00am •
#310: Project Planning 101: Turning Strategy into Execution
10:30am •
#337: Application of Project Management Methodologies and Tools in NonProfit Institutions
2:00pm •
#364: Effective Portfolio Management of Assets Across an Organization
4:15pm •
#386: Setting the Stage for Effective Stakeholder Collaboration
Room 16AB
8:00am •
#319: How to Solve the Problem of Access for Rare Diseases
2:00pm •
#366: Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4)
3:30pm •
#378.1 SB: On the Soapbox: Good for People and Good for Research - Individuals as Research Partners
4:15pm •
#391: Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies
Room 17AB
8:00am •
#311: Improving Trial Quality by Better Preparing Site Teams
10:30am •
#338: Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability
2:00pm •
#365: Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment
4:15pm •
#387: Global Perspective on ICH E8(R1): General Considerations for Clinical Trials
Room 1AB
8:00am •
#306: Methods for Integrating EHR Data into EDC and eSource Databases
10:30am •
#332: eSource Adoption: Where We Are - Our Experiences from eSource Implementation
2:00pm •
#360: Identification of Medicinal Products: FDA's Perspective and Approach
4:15pm •
#382: Real World Data Quality for Regulatory Decision-Making
Room 2
8:00am •
#309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities
10:30am •
#336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs
2:00pm •
#363: Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development
4:15pm •
#385: The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety
Room 3
8:00am •
#316: Implementation of Innovative and Adaptive Designs in Clinical Trials
10:30am •
#344: Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine
2:00pm •
#371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information
4:15pm •
#395: Utilization and Evaluation of Innovative Approaches for Efficient Drug Development
Room 4
8:00am •
#307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?
10:30am •
#333: Pediatric Plans: The Challenges Between Regulations and Reality
2:00pm •
#361: Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB
4:15pm •
#383: Next-Generation Approaches for Developing Narratives
Room 5AB
8:00am •
#308: Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups
10:30am •
#334: Understanding and Exploring Elements of a Patient-Focused Product Launch
2:00pm •
#362: Patient Engagement Quality Guidance: Results and Learnings from Global Multistakeholder Pilots
4:15pm •
#384: Patient Preferences in Decision Making and the PREFER Project: Past, Present, and Future
Room 6B
10:30am •
#339: Hot Topics in Quality and Regulatory Affairs for Combination Products
2:00pm •
#367: Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?
4:15pm •
#389: Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines?
Room 6C
8:00am •
#301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment
10:30am •
#327: Digital Risk Minimization: The “Next Generation” Risk Management Tools
2:00pm •
#355: History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned?
4:15pm •
#379: From Trials to Real World: How Safety Protocols Impact REMS
Room 6D
8:00am •
#302: Triple-s (3S) Smart Safety Surveillance
10:30am •
#342: When is Real World Evidence Ready for Prime Time?
2:00pm •
#356: Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing?
4:15pm •
#392: Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry
Room 6E
8:00am •
#313: Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why
10:30am •
#341: The Evolving Gene Therapy Regulatory Framework: A Brave New World
2:00pm •
#369: User-Fee Programs Myth Busting: General Financial Principles Explained
4:15pm •
#390: Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints
Room 6F
8:00am •
#314: Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?
10:30am •
#340: Digital Technology Advances Labeling Management and Patient Access
2:00pm •
#368: Global Rare Disease Town Hall
4:15pm •
#388: Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products
Room 8
8:00am •
#315: Measuring and Assessing Product Manufacturing Quality
10:30am •
#343: Efficient Preparation of Global CMC Dossiers
2:00pm •
#370: Challenges and Opportunities in Product Quality: Lifecycle Management
4:15pm •
#393: Case Studies in Resolving Quality Issues
Room 9
8:00am •
#305: Demystifying Technology Selection in Mobile Clinical Trials
10:30am •
#328: Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow
2:00pm •
#358: Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles
4:15pm •
#380: Incorporating Patient Input into the Design and Conduct of Clinical Trials
Sails Pavilion
7:00am •
Coffee and Light Refreshments
7:00am •
Attendee, Speaker, and Exhibitor Registration
Theater 1 Exhibit Hall
9:45am •
#324 IT: Salesforce Innovation Theater: Digital R&D: Accelerating intelligent innovation with IQVIA’s Orchestrated Clinical Trials Platform, powered by Salesforce Health Cloud
11:40am •
#346 IT: IQVIA Innovation Theater: Clinical Development Innovation Through the Lens of Data Science
12:40pm •
#350 IT: IQVIA Innovation Theater: The Digital Patient Experience
1:40pm •
#353.1 IT: Tata Consultancy Services: Enabling Perpetual Digital Transformation in Research & Development
Theater 2 Exhibit Hall
9:45am •
#325 IT: SAS Institute Inc JMP Innovation Theater: Semi-automation of the Narrative Section of the Clinical Study Report for Oncology Studies
11:40am •
#347 IT: ZS Innovation Theater: Designing With Confidence
12:40pm •
#350.1 IT: Oracle Health Sciences Innovation Theater: The AI Revolution in Multivigilance
1:40pm •
#354 IT: PRA Health Sciences Innovation Theater: The Importance and Impact of Age Specific Content in Pediatric Studies
Timezone
DIA 2019 Global Annual Meeting
America/Los Angeles
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DIA 2019 Global Annual Meeting
Jun 22
-
27, 2019
Saturday
, June 22
Sunday
, June 23
Monday
, June 24
Tuesday
, June 25
Wednesday
, June 26
Thursday
, June 27
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Ballroom 20
Ballroom 20 Lobby
Booth #1531 Exhibit Hall
Community Area 2 Sails
Community Area Sails Pav
Community Zone 3 Sails
Community Zone Sails Pav
Content Hub Sails Pav
E and E Area Exh Hall
Exhibit Hall
Marriott Marquis Marina
Posters Exhibit Hall
Room 10
Room 11A
Room 11B
Room 14A
Room 14B
Room 15AB
Room 16AB
Room 17AB
Room 1AB
Room 2
Room 3
Room 4
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Room 6B
Room 6C
Room 6D
Room 6E
Room 6F
Room 8
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Sails Pavilion
TBD
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Filter By Type
00: Plenary
All
Forum
01: ClinSafety-PV
All
Forum
Session
Tutorial
Workshop
02: ClinTrials -ClinOps
All
Forum
Session
Tutorial
Workshop
03: Data-Data Standards
All
Forum
Session
Tutorial
Workshop
04: MedAffairs-SciComm
All
Forum
Session
Tutorial
05: Patient Engagement
All
Forum
Session
Tutorial
Workshop
06: PreClin Dev-EarlyPhaseCR
All
Forum
Session
Tutorial
07: ProjMgt-StrategicPlanning
All
Forum
Session
Workshop
08: R-D Quality-Compliance
All
Forum
Session
Tutorial
Workshop
09: Regulatory
All
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Session
Tutorial
Workshop
10: RegCMC-Product Quality
All
Forum
Session
Tutorial
Workshop
11: Statistics
All
Forum
Session
Tutorial
Workshop
12: Value-Access
All
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Session
Workshop
13: ProfDevelopment
All
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Session
Workshop
14: DIAmond
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15: Engage-Exchange
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16: Content Hubs
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17: Community Rounds
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18: InnovTheater
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19: Posters
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Level
Advanced
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Featured Topics
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Patient Focused
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Real World Evidence
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Saturday
, June 22
Sunday
, June 23
Monday
, June 24
Tuesday
, June 25
Wednesday
, June 26
Thursday
, June 27
Venue
Ballroom 20
Ballroom 20 Lobby
Booth #1531 Exhibit Hall
Community Area 2 Sails
Community Area Sails Pav
Community Zone 3 Sails
Community Zone Sails Pav
Content Hub Sails Pav
E and E Area Exh Hall
Exhibit Hall
Marriott Marquis Marina
Posters Exhibit Hall
Room 10
Room 11A
Room 11B
Room 14A
Room 14B
Room 15AB
Room 16AB
Room 17AB
Room 1AB
Room 2
Room 3
Room 4
Room 5AB
Room 6B
Room 6C
Room 6D
Room 6E
Room 6F
Room 8
Room 9
Sails Pavilion
TBD
Theater 1 Exhibit Hall
Theater 2 Exhibit Hall
Session Type
00: Plenary
All
Forum
01: ClinSafety-PV
All
Forum
Session
Tutorial
Workshop
02: ClinTrials -ClinOps
All
Forum
Session
Tutorial
Workshop
03: Data-Data Standards
All
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Session
Tutorial
Workshop
04: MedAffairs-SciComm
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Session
Tutorial
05: Patient Engagement
All
Forum
Session
Tutorial
Workshop
06: PreClin Dev-EarlyPhaseCR
All
Forum
Session
Tutorial
07: ProjMgt-StrategicPlanning
All
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Session
Workshop
08: R-D Quality-Compliance
All
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Session
Tutorial
Workshop
09: Regulatory
All
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Session
Tutorial
Workshop
10: RegCMC-Product Quality
All
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Session
Tutorial
Workshop
11: Statistics
All
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Workshop
12: Value-Access
All
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13: ProfDevelopment
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14: DIAmond
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15: Engage-Exchange
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16: Content Hubs
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17: Community Rounds
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18: InnovTheater
All
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19: Posters
All
Poster Presentation
Networking-CommunityEvents
All
Forum
Session
Social Event
Short Course
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Other Filters
Level
Advanced
Beginner
Intermediate
Featured Topics
Advanced Therapies
Artificial Intelligence
Generics
Innovative Trial Design
Patient Focused
Precision Medicine
Rare Disease
Real World Evidence
Regulator Thinking
Student Programming
What's Next
