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00: Plenary
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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
Forum
Session
Tutorial
Workshop
10: RegCMC-Product Quality
All
Forum
Session
Tutorial
Workshop
11: Statistics
All
Forum
Session
Tutorial
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: ProfDevelopment
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Forum
Session
Workshop
14: DIAmond
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Forum
15: Engage-Exchange
All
Workshop
16: Content Hubs
All
Workshop
17: Community Rounds
All
Session
18: InnovTheater
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Session
19: Posters
All
Poster Presentation
Networking-CommunityEvents
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Forum
Session
Social Event
Short Course
All
Tutorial
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
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Saturday
, June 22
Sails Pavilion
8:00am •
Exhibitor Registration
Sunday
, June 23
Marriott Marquis Marina
11:00am •
Forum for Students and Emerging Professionals
Room 11A
9:00am •
SC40: #40: Interdisciplinary Safety Evaluation During Product Development
Room 11B
9:00am •
SC42: #42: Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision Making
Room 14B
12:45pm •
Student Networking Luncheon
3:45pm •
#002: Student and Young Professional Resume Workshop
Room 15AB
2:30pm •
#001: Self-Branding for Social Media
3:45pm •
#003: Effective Networking: Know Yourself
Room 1AB
9:00am •
SC20: #20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?
Room 2
9:00am •
SC21: #21: Basics of European Medical Device Regulation
1:30pm •
SC36: #36: A Novel Interactive Safety Graphic to Evaluate Potential Drug-Induced Hepatotoxicity
Room 3
9:00am •
SC22: #22: Protocol Co-Design with Patients and Advocates
1:30pm •
SC37: #37: Patient Literacy 101: Practical Strategies for Improving Your Patient Materials
Room 4
9:00am •
SC27: #27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies
1:30pm •
SC35: #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Room 5AB
9:00am •
SC24: #24: Data Visualization in the Life Sciences
1:30pm •
SC30: #30: Machine Learning in Pharmacovigilance
Room 6D
9:00am •
SC28: #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
1:30pm •
SC34: #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Room 6E
9:00am •
SC23: #23: Preparing for a US FDA Advisory Committee Meeting
1:30pm •
SC33: #33: European Regulatory Meetings: How Best to Prepare and Perform
Room 8
9:00am •
SC41: #41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
Room 9
9:00am •
SC43: #43: Back to the Future: Combination Products in the 21st Century
Sails Pavilion
8:00am •
Registration for Full Day and Morning Preconference Short Courses
8:00am •
Exhibitor Registration
12:30pm •
Registration for Afternoon Preconference Short Courses, Conference Attendees, and Speakers
Monday
, June 24
Ballroom 20
8:00am •
#100: Opening Plenary, Keynote, and DIAmond Session
Ballroom 20 Lobby
7:00am •
Coffee and Light Refreshments
Community Area 2 Sails
6:00pm •
Community Meet Up: Statistics Community Meet and Greet
Community Area Sails Pav
12:30pm •
Community Meet Up: Discussion on Data Quality, Real-Time Calculated Metrics, Compliance
3:30pm •
Community Meet Up: Forum of Pharmacovigilance Quality Heads
Community Zone Sails Pav
1:15pm •
#130 RT: Round Table Discussion: Emerging Technologies in Clinical Research
Content Hub Sails Pav
10:10am •
#101 CH: Modernizing Data Review in Drug Development with R Shiny
12:15pm •
#122 CH: Leveraging Extra Value from an Intern Program: Non- Traditional Majors Add Unexpected Value
1:00pm •
#126 CH: Separating the Hype from Reality in Pharmacovigilance Automation
1:45pm •
#132 CH: Advancing Trailblazing Research and Development: When to Speed Up, When to Slow Down
3:30pm •
#172 CH: Paving the Path for Family-Centered Design: Caregiver Roles in Medical Product Development
E and E Area Exh Hall
10:10am •
#102 EE: The Female Perspective on the Clinical Trial Patient Experience: A Live Focus Group
12:15pm •
#125 EE: ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)
1:15pm •
#129 EE: The Potential Value of Shared Decision Making (SDM) in Clinical Trial Consideration and Participation
5:15pm •
#175 EE: Data Analytics Use in Quality Processes
Exhibit Hall
10:00am •
Coffee Break
12:00pm •
Luncheon Service
4:30pm •
DIA Welcome Reception
Posters Exhibit Hall
10:00am •
Student Poster Session
Room 10
11:00am •
#109: When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters
2:15pm •
#139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans
3:30pm •
#158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Room 11A
11:00am •
#107: Emerging Technologies in Clinical Research
2:15pm •
#137: Emerging Technology to Improve Sponsor-Site Interactions
3:30pm •
#157: A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale
Room 11B
11:00am •
#119: Making Value-Based Contracting Stick
2:15pm •
#149: Hype Versus Reality: Artificial Intelligence and Drug Development
Room 14A
11:00am •
#121: Emerging Professionals: Making the Most of Your Networking Experience at the DIA Global Annual Meeting
2:15pm •
#153: How Storytelling, Images, and Engagement Can Wow Your Audience: Presentations with Punch!
3:30pm •
#171: The Courage of Career Transitions
Room 14B
7:00am •
Annual Meeting Orientation
11:00am •
#120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What?
2:15pm •
#150: TFDA Town Hall: Focus on Regenerative Medicine
3:30pm •
#170: Making Early Access for Patients Happen
Room 15AB
11:00am •
#114: Patient Perspective Diversity: Taking Cultural Differences in Patient Views Into Consideration in US, EU, and Japan
2:15pm •
#144: Ready or Not: Business Continuity Planning
3:30pm •
#163: Strategic Integration: Is Anyone Getting it Right?
Room 16AB
1:30pm •
#131 SB: On the Soapbox: Designing Babies - Medical, Ethical, and Social Questions
Room 17AB
11:00am •
#115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2)
2:15pm •
#145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma
3:30pm •
#164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health
Room 1AB
11:00am •
#110: Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management
2:15pm •
#140: Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters
3:30pm •
#159: Understanding the Data Journey In Virtual Trials
Room 2
11:00am •
#113: Artificial Intelligence in Drug Discovery and Development: Emerging Technologies and Applications
2:15pm •
#143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology
3:30pm •
#162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption
Room 3
11:00am •
#118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval
2:15pm •
#152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis
3:30pm •
#169: How Statistics Can Help Improve Data Quality: ICH E6 R2
Room 4
11:00am •
#111: PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives
2:15pm •
#141: Knowledge Management and Information Sharing to Support Business Continuity
3:30pm •
#160: New Communication Channels for Medical Information
Room 5AB
11:00am •
#112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations
2:15pm •
#142: Show Me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation
3:30pm •
#161: Making Trials Work for Special Populations
Room 6B
11:00am •
#117: International Regulatory Convergence
2:15pm •
#146: Communications with Regulators Beyond Formal Meetings
3:30pm •
#167: Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry
Room 6C
11:00am •
#106: Moving Forward in EU Pharmacovigilance
2:15pm •
#136: Interpretation of New Pharmacovigilance Regulations: Key Insights
3:30pm •
#154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
Room 6D
11:00am •
#105: Addressing Heterogeneity of Real World Evidence in Drug Safety
2:15pm •
#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity
3:30pm •
#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Room 6E
2:15pm •
#148: Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?
3:30pm •
#166: Updates on China Regulatory Reform
Room 6F
11:00am •
#116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs
2:15pm •
#147: Update from Health Canada: The Health Protection Branch
3:30pm •
#165: Drug Development Tools in a Digital Era
Room 8
2:15pm •
#151: Update on ICH Quality Topics
3:30pm •
#168: Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities
Room 9
11:00am •
#108: Innovation in Enrollment, Recruitment, and Retention
2:15pm •
#138: Blockchain in Clinical Trials Demo: Truth or Dare
3:30pm •
#156: Clinical Research in Emerging Regions
Sails Pavilion
7:00am •
Attendee, Speaker, and Exhibitor Registration
TBD
5:15pm •
Community Meet Up: Patient Engagement
Theater 1 Exhibit Hall
10:15am •
#103 IT: Advanced Clinical Innovation Theater: Raising the Bar on Clinical Oversight to Reduce Risk and Ensure Inspection Readiness
12:15pm •
#123 IT: IQVIA Innovation Theater: When Context is Hard to Come By – The Emerging Value of External Comparators
1:00pm •
#127 IT: Veeva Systems Innovation Theater: Annual Industry Report: Trends, Insights, and Strategies to Improve Study Execution
1:45pm •
#133 IT: Cognizant Innovation Theater: Shared Investigator Platform: Innovating Clinical Trials Feasibility and Study Start Up
4:45pm •
#173 IT: Appian Innovation Theater: Accelerating the Regulatory Information Management Journey with Intelligent Automation
5:30pm •
#176 IT: Statistics & Data Corporation Innovation Theater: Artificial Intelligence and Machine Learning: Innovations in Clinical Trial Data Automation
Theater 2 Exhibit Hall
10:15am •
#104 IT: ArisGlobal Innovation Theater: Can Blockchain Technology Change Life Sciences?
12:15pm •
#124 IT: Parexel Innovation Theater: Transforming the Drug Development Journey Through the Patient’s Eyes
1:00pm •
#128 IT: WIRB-Copernicus Group Innovation Theater: Getting the Most Out of Your Site Selection Strategy
1:45pm •
#134 IT: SAS Institute Inc Innovation Theater: Smarter Clinical Trial Enrollment with Real World Data and Simulation Analytics
4:45pm •
#174 IT: Deloitte Consulting Innovation Theater: Reimagining Patient Safety
5:30pm •
#177 IT: Syneos Health Innovation Theater: Dialing In the Optimal FSP Solution
Tuesday
, June 25
Ballroom 20 Lobby
12:15pm •
DIA Community Luncheon
Booth #1531 Exhibit Hall
3:30pm •
Annual Meeting of Members
Community Area 2 Sails
5:00pm •
Community Meet Up: Medical Writing Community Meet and Greet
Community Area Sails Pav
7:30am •
DIAlogue Session 1: Welcome to Day 2 of DIA 2019
2:00pm •
DIAlogue Session 2: Publications Meet Up - Inside the DIA Journal
4:15pm •
Community Meet Up: Member Networking and Making the Most of your Membership
Community Zone 3 Sails
5:00pm •
Community Meet Up: Women in Life Sciences
Community Zone Sails Pav
9:30am •
#223 RT: Round Table Discussion: Interpretation of New Pharmacovigilance Regulations: Key Insights
9:30am •
#224 RT: Round Table Discussion: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
2:00pm •
#254.1 RT: Round Table Discussion: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
3:15pm •
#276 RT: Round Table Discussion: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
3:15pm •
#277 RT: Round Table Discussion: Clinical Research in Emerging Regions
Content Hub Sails Pav
7:30am •
Talent Show
9:15am •
#221 CH: Getting the Question Right (GTQR) with Interdisciplinary Collaboration
10:00am •
#227 CH: GCP for Contributing Investigator Versus Conducting Investigator-Initiated Trials in Emerging Regions
11:45am •
#250 CH: How to Efficiently Implement a Healthcare Compliance Program in Preparation for Your First Product Launch
3:30pm •
#278 CH: How to Write a Compelling Poster Abstract
4:15pm •
#299.1 CH: Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process
E and E Area Exh Hall
9:30am •
#222 EE: The Negotiation Game: Learn What you Never Knew About Negotiation in a Fun, Interactive, Collaborative Game
2:00pm •
#274 EE: Pharma Powered by the Digital
3:15pm •
#275 EE: Access to Investigational Drugs Outside of Clinical Trials: What's Fair?
Exhibit Hall
9:15am •
Coffee Break
11:30am •
Luncheon Service
3:15pm •
Refreshment Break
Posters Exhibit Hall
9:00am •
Professional Poster Session 1
Room 10
8:00am •
#205: Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence
10:30am •
#230: Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process
2:00pm •
#256: Wearables and Patient Technologies Utilized in Clinical Trials
4:15pm •
#284: Virtual Clinical Trials
Room 11A
8:00am •
#203: eConsent Done Right
10:30am •
#232: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
2:00pm •
#257: Clinical Trial Diversity: Moving from Admiring the Problem to Solving it
4:15pm •
#285: Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions
Room 11B
8:00am •
#216: Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs
10:30am •
#235: Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives
2:00pm •
#267: Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4)
4:15pm •
#288: The Changing Landscape of Medical Affairs: Are We Prepared For 2020?
Room 14A
8:00am •
#220: DISC and RISK: How DISC Profile in Clinical Trial Teams Impact Implementation of Risk-Based Approaches
10:30am •
#247: Pregnancy, Breastfeeding, Childcare, Oh My! Finding a Balance for New Moms
2:00pm •
#273: Presentations as Listeners Like Them: How to Tailor Messaging
Room 14B
8:00am •
#219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?
10:30am •
#246: How Employers are Reinventing Healthcare and What it Means for Research Participation and Evidence
2:00pm •
#272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience
4:15pm •
#299: Public and Regulatory Response To Drug Pricing Concerns
Room 15AB
8:00am •
#210: Increasing Personal Resilience To Manage Change
10:30am •
#238: Build and Leverage Your Networks to Influence Stakeholders
2:00pm •
#265: Decision Leadership: How Using a Structured Approach to Decision Making Can Help You Lead Teams Better
4:15pm •
#292: Conversations with the Participant: Layperson Summaries and Return of Results
Room 16AB
8:00am •
#212: Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)
10:30am •
#243: The Future of Combination Products in the EU
2:00pm •
#262: Measuring the Impact of Patient Engagement Activities in Medicines R&D: A Way to Sustain the Cultural Change?
4:15pm •
#290: The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics
Room 17AB
8:00am •
#211: Pharmacovigilance Reporting and Quality
10:30am •
#239: Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose
2:00pm •
#266: Electronic Systems: Are Yours Fit for Purpose?
4:15pm •
#293: Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?
Room 1AB
8:00am •
#206: Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data
10:30am •
#233: Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders
2:00pm •
#259: FDA Data Standards Update
4:15pm •
#286: The Machines are Here! Learn About Real Uses of Machine Learning and Artificial Intelligence in Pharma
Room 2
8:00am •
#209: Emerging Issues in CRISPR and Gene Editing Symposium
10:30am •
#237: The Rare Disease Experience in Clinical Trials
2:00pm •
#264: Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges
Room 3
8:00am •
#218: Real World Data to Real World Evidence
10:30am •
#245: Artificial Intelligence Enhanced Data Analytics for Clinical Trials
2:00pm •
#271: Master Protocols: Applications in Oncology
4:15pm •
#298: Clinical Safety Assessment: What’s a Statistician Got to Do with It?
Room 4
8:00am •
#207: Leveraging Artificial Intelligence and Natural Language Processing in Medical Writing
10:30am •
#234: Quality and Compliance Management in Medical Information/Medical Affairs
2:00pm •
#260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients
4:15pm •
#287: A Case Study in Structuring Clinical Content and Structured Content Management (SCM)
Room 5AB
8:00am •
#208: Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges
10:30am •
#236: Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA
2:00pm •
#261: Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development?
4:15pm •
#289: Impact of Patient Engagement on the Biopharmaceutical Industry's Business and Organization
Room 6B
8:00am •
#213: Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases
10:30am •
#242: Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project
2:00pm •
#268: Current Status of FDA Framework for the Evaluation of Real World Evidence
4:15pm •
#295: Prescription Drug Labeling: New Guidances from the US FDA
Room 6C
8:00am •
#201: To Err is Human: Progress and Challenges in the Prevention of Medication Errors
10:30am •
#229: An Industry Collaboration on Pharmacovigilance Analytics
2:00pm •
#255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance
4:15pm •
#281: Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development
Room 6D
8:00am •
#202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
10:30am •
#228: Emerging Safety Challenges in New Oncology Treatments
2:00pm •
#263: Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives
4:15pm •
#282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
Room 6E
8:00am •
#215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges
10:30am •
#241: PMDA Town Hall
4:15pm •
#296: Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence
Room 6F
8:00am •
#214: Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?
10:30am •
#240: Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)
2:00pm •
#269: Driving Complex Generics to Approval: What are the Keys to Success
4:15pm •
#294: Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education
Room 8
8:00am •
#217: Quality Considerations for Complex Generics
10:30am •
#244: Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts
2:00pm •
#270: Where Quality Meets Safety and Efficacy: An Interactive Experience
4:15pm •
#297: Integration of Manufacturing Quality Assessment and Pre-Approval Inspections
Room 9
8:00am •
#204: Protocol Developments of the Future
10:30am •
#231: Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies
2:00pm •
#258: Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You
4:15pm •
#283: Let's Talk Risk-Based Monitoring
Sails Pavilion
7:00am •
Coffee and Light Refreshments
7:00am •
Attendee, Speaker, and Exhibitor Registration
Theater 1 Exhibit Hall
9:45am •
#225 IT: DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation: ‘Wide-Angle-Data’ – Fully Integrated Platform with Advanced Analytics and Customized Algorithms for Real Time Safety and Risk Management
11:40am •
#248 IT: Veeva Systems Innovation Theater: Shortening Database Builds by 40-60%
12:40pm •
#251 IT: AMPLEXOR Innovation Theater: The Great Regulatory Catch-up: Lessons From Big Pharma as Medical Device Manufacturers Succumb to New Reporting Rigor
1:40pm •
#253 IT: UBC Innovation Theater: Standardizing and Enhancing Registry Data to Improve Evidence Generation
3:30pm •
#279 IT: PPD Innovation Theater: Have you Considered Market Access in Your Trial Design
Theater 2 Exhibit Hall
9:45am •
#226 IT: Covance Innovation Theater: Fixing the Patient Recruitment "Leaky Funnel"
11:40am •
#249 IT: ArisGlobal Innovation Theater: Getting More Value From Your Data Through A Unified Regulatory Platform
12:40pm •
#252 IT: Bioclinica Innovation Theater: When EDC is not Enough: Automating Multi-Country Data Collection and Complex Workflows
1:40pm •
#254 IT: IBM Watson Health Innovation Theater: Real World Insights and Collaboration in Protocol Development
3:30pm •
#280 IT: Parexel and Microsoft Innovation Theater: Change The Way You Work: Transforming Regulatory Processes with Parexel and Microsoft
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
Thursday
, June 27
Content Hub Sails Pav
8:30am •
#402 CH: Manage Risks and Enhance Engagement Through Digital Approaches
Room 10
9:00am •
#405: eSource and the Sites: Have They Bonded?
Room 11A
9:00am •
#404: Investigational Medicinal Products: eLabeling Initiative, Supply Forecasting Strategies, and Patient-Centric Technology for Medicine Adherence
Room 1AB
9:00am •
#406: Electronic Submissions Update
Room 2
9:00am •
#408: FDA Botanicals
Room 5AB
9:00am •
#407: A Patient Engagement Wrap Up: Lessons Learned from DIA 2019 and Where Do We Go from Here
Room 6B
9:00am •
#412: Keeping Up with FDA and EMA Collaborations: Question Time
10:45am •
#413: FDA Town Hall
Room 6C
9:00am •
#409: Case Studies From FDA and MHRA: Good Clinical Practices
Room 6D
9:00am •
#403: Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars
Room 6F
9:00am •
#410: Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics
Room 8
9:00am •
#411: Recent CMC Changes in Emerging Regulatory Agencies
Sails Pavilion
8:00am •
Coffee and Light Refreshments
8:00am •
Attendee and Speaker Registration
Timezone
DIA 2019 Global Annual Meeting
America/Los Angeles
Filter By Date
DIA 2019 Global Annual Meeting
Jun 22
-
27, 2019
Saturday
, June 22
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, June 23
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, June 24
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, June 25
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, June 26
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, June 27
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San Diego, CA, USA
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Sails Pavilion
TBD
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Dates
Saturday
, June 22
Sunday
, June 23
Monday
, June 24
Tuesday
, June 25
Wednesday
, June 26
Thursday
, June 27
Types
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
Forum
Session
Tutorial
Workshop
10: RegCMC-Product Quality
All
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Session
Tutorial
Workshop
11: Statistics
All
Forum
Session
Tutorial
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: ProfDevelopment
All
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Session
Workshop
14: DIAmond
All
Forum
15: Engage-Exchange
All
Workshop
16: Content Hubs
All
Workshop
17: Community Rounds
All
Session
18: InnovTheater
All
Session
19: Posters
All
Poster Presentation
Networking-CommunityEvents
All
Forum
Session
Social Event
Short Course
All
Tutorial
Venues
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
