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DIA 2024 Global Annual Meeting
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00: Plenary
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01: ClinSafety-PV
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02: ClinTrials -ClinOps
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03: Data-Tech
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Session
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04: MedAffairs-SciComm
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05: Patient-Focused Drug Dev
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06: TranslationalDelivery Tech-PrecMedicine
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07: ProjectManagement-StrategicPlanning
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08: RD Quality-Compliance
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09: Regulatory
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10: RegCMC-Product Quality
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11: Statistics-Data Science
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12: Value-Access
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13: ProfDevelopment
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14: DIAmond
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15: Content Hubs
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16: Community Rounds
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17: Networking Opportunities
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19: InnovationTheaters
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20: Short Courses
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Featured Topics
Artificial Intelligence (AI)
Cell and Gene Therapy
Decentralized Clinical Trials (DCTs)
Digital Technology
Diversity Equity and Inclusion (DEI)
Ethics
ICH
Patient Focused
Rare Disease
Real-World Data (RWD)- Real-World Evidence (RWE)
Regulator Perspectives
Regulatory Collaboration
Regulatory Reliance
Risk Management
Special Populations
Student Programming
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Monday
, June 17
11:00am PDT
#104: Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards
Room 15AB
#106: Machine Learning and Simulations to Facilitate Clinical Trials
Room 5AB
#105: The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development
Room 17AB
#109: GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US?
Room 1AB
2:15pm PDT
#132: The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning and Resourcing
Room 5AB
#133: ICH M11 Protocol Template: A Global Solution for Global Drug Development
Room 17AB
#131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation
Room 14AB
#134: Shifting Medical Writing Value Propositions with the Use of Technology Tools
Room 2
#138: Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective
Room 6D
#139: Comparative Perspectives on Regulating AI in Drug Development: US Versus EU
Room 6C
#137: Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines
Room 1AB
#136: In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs
Room 15AB
#141: Innovation in Manufacturing Globally
Room 11AB
#142: Causal Inference Methodology in Drug Development
Room 6E
3:30pm PDT
#144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward
Room 6C
#145: Selective Safety Data Collection: As a Tool to Advance Clinical Trial Designs
Room 5AB
#148: Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Room 7AB
#152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond
Room 17AB
#153: Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking
Room 15AB
#154: Impact of Accelerated Pathways on Patients in Five Countries/Regions
Room 11AB
#155: Health Canada Town Hall
Room 6D
#156: Data Insight Generation: Leveraging Data Visualization in Study Planning, Monitoring, Exploration, Reporting, and Submission
Room 6E
#151: Elevate Leadership: Harnessing the Five Superpowers
Room 2
Tuesday
, June 18
8:00am PDT
#201: Considerations for Identification of Drug-Induced Liver Injury
Room 6D
#204: Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders
Room 5AB
#206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making
Room 16AB
#208: Good Data Governance Practices: Regulatory and Industry Perspectives
Room 14AB
#211: PMDA Town Hall
Room 15AB
#212: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
Room 6F
#213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications
Room 17AB
10:00am PDT
#222: External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms
Room 11AB
#225: Regulatory Guidance and Papers on Technology Innovations
Room 6D
#227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective
Room 17AB
#228: Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement
Room 16AB
1:15pm PDT
#244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time
Room 17AB
#252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features
Room 15AB
#248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Room 6F
#249: Topics Related to the Oncology Real-Time Oncology Review Process
Room 1AB
#254: FDA Rare Disease Town Hall
Room 6A
#245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On
Room 5AB
3:15pm PDT
#263: Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward
Room 6B
#270: Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management
Room 8
#271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?
Room 16AB
#272: This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice
Room 6F
#273: How to Provide Necessary Medicinal Products to Children?
Room 17AB
#267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare
Room 11AB
#275: Securing the Chain: US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
Room 6D
4:30pm PDT
#277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data
Room 11AB
#278: Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy
Room 6C
#284: Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance
Room 5AB
#281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU
Room 6B
#279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials
Room 6F
#285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox
Room 16AB
#290: Charting the Biosimilars Beat Drop: The Latest Updates in the Biosimilars Landscape, Coverage, and Adoption in the US
Room 8
#283: The Value of Project Management in Driving Drug Discovery Success: A Comparison Between Small Versus Large Pharmaceutical Companies
Room 2
Wednesday
, June 19
8:00am PDT
#301: Risk Minimization in the EU: New Guidance, New Collaborations
Room 11AB
#302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics
Room 6A
#309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”
Room 6F
#307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products
Room 2
10:00am PDT
#324: Using Data Analytics for Good Pharmacovigilance Practices
Room 15AB
#320: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases
Room 8
#321: The ChatBot Will See You Now: Ethical Considerations in Incorporating AI into Informed Consent
Room 7AB
#323: Driving Capacity Building, Equity, and Geographic Expansion in Clinical Trials
Room 2
#326: Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products
Room 6C
#327: Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals
Room 14AB
1:15pm PDT
#345: Regulatory Considerations in Trial Design for Cell and Gene Therapies
Room 5AB
#346: A Clinical Research Workforce in Crisis: Imperatives for a Sustainable Staffing Model
Room 6C
#351: Revolutionizing Quality Management: Harnessing the Power of AI for Enhanced Decision Making and Continuous Improvement
Room 17AB
#353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance
Room 16AB
#354: ICMRA Post-Pandemic: Regulators Looking into the Future
Room 6A
#350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development
Room 11AB
3:15pm PDT
#360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color
Room 6B
#366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis
Room 5AB
#364: Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey
Room 2
#363: Implementing Changes To Drug-Device Combination Products Globally
Room 1AB
#368: Harnessing the Power of Artificial Intelligence (AI) in Clinical Research From Knowledge Graphs to Generative AI
Room 6E
#361: Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future
Room 6D
4:30pm PDT
#370: Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance
Room 6B
#373: Patient-Centric Approaches in Summaries and Data Return
Room 6D
#371: Using Influencers to Recruit Hard-to-Engage Populations
Room 7AB
#376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices
Room 6E
#377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework
Room 1AB
Thursday
, June 20
8:00am PDT
#401: Harnessing Real-World Data to Generate Real-World Evidence for Regulatory Grade Safety Studies
Room 6C
#407: Leveraging Statistical Approaches in Drug Safety Analysis
Room 1AB
#408: Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine
Room 6D
9:15am PDT
#411: Generative AI-Driven Clinical Data Management: A Myth or a Reality?
Room 6D
#410: The Impact of Racial Discrimination on the Patient Clinical Trial Experience
Room 1AB
#412: Unleashing Biopharma Potential: Maximizing Consortia Engagement with Strategic Change Management
Room 2
#413: What is the Value of Reference Agency Assessment Reports in Enabling Reliance and What do Relying Agencies Require?
Room 6C
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DIA 2024 Global Annual Meeting
Jun 16
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20, 2024
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Featured Topics
Artificial Intelligence (AI)
Cell and Gene Therapy
Decentralized Clinical Trials (DCTs)
Digital Technology
Diversity Equity and Inclusion (DEI)
Ethics
ICH
Patient Focused
Rare Disease
Real-World Data (RWD)- Real-World Evidence (RWE)
Regulator Perspectives
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America/Dominica
America/Edmonton
America/Eirunepe
America/El Salvador
America/Fort Nelson
America/Fortaleza
America/Glace Bay
America/Goose Bay
America/Grand Turk
America/Grenada
America/Guadeloupe
America/Guatemala
America/Guayaquil
America/Guyana
America/Halifax
America/Havana
America/Hermosillo
America/Indiana/Indianapolis
America/Indiana/Knox
America/Indiana/Marengo
America/Indiana/Petersburg
America/Indiana/Tell City
America/Indiana/Vevay
America/Indiana/Vincennes
America/Indiana/Winamac
America/Inuvik
America/Iqaluit
America/Jamaica
America/Juneau
America/Kentucky/Louisville
America/Kentucky/Monticello
America/Kralendijk
America/La Paz
America/Lima
America/Los Angeles
America/Lower Princes
America/Maceio
America/Managua
America/Manaus
America/Marigot
America/Martinique
America/Matamoros
America/Mazatlan
America/Menominee
America/Merida
America/Metlakatla
America/Mexico City
America/Miquelon
America/Moncton
America/Monterrey
America/Montevideo
America/Montserrat
America/Nassau
America/New York
America/Nome
America/Noronha
America/North Dakota/Beulah
America/North Dakota/Center
America/North Dakota/New Salem
America/Nuuk
America/Ojinaga
America/Panama
America/Paramaribo
America/Phoenix
America/Port-au-Prince
America/Port of Spain
America/Porto Velho
America/Puerto Rico
America/Punta Arenas
America/Rankin Inlet
America/Recife
America/Regina
America/Resolute
America/Rio Branco
America/Santarem
America/Santiago
America/Santo Domingo
America/Sao Paulo
America/Scoresbysund
America/Sitka
America/St Barthelemy
America/St Johns
America/St Kitts
America/St Lucia
America/St Thomas
America/St Vincent
America/Swift Current
America/Tegucigalpa
America/Thule
America/Tijuana
America/Toronto
America/Tortola
America/Vancouver
America/Whitehorse
America/Winnipeg
America/Yakutat
Antarctica/Casey
Antarctica/Davis
Antarctica/DumontDUrville
Antarctica/Macquarie
Antarctica/Mawson
Antarctica/McMurdo
Antarctica/Palmer
Antarctica/Rothera
Antarctica/Syowa
Antarctica/Troll
Antarctica/Vostok
Arctic/Longyearbyen
Asia/Aden
Asia/Almaty
Asia/Amman
Asia/Anadyr
Asia/Aqtau
Asia/Aqtobe
Asia/Ashgabat
Asia/Atyrau
Asia/Baghdad
Asia/Bahrain
Asia/Baku
Asia/Bangkok
Asia/Barnaul
Asia/Beirut
Asia/Bishkek
Asia/Brunei
Asia/Chita
Asia/Choibalsan
Asia/Colombo
Asia/Damascus
Asia/Dhaka
Asia/Dili
Asia/Dubai
Asia/Dushanbe
Asia/Famagusta
Asia/Gaza
Asia/Hebron
Asia/Ho Chi Minh
Asia/Hong Kong
Asia/Hovd
Asia/Irkutsk
Asia/Jakarta
Asia/Jayapura
Asia/Jerusalem
Asia/Kabul
Asia/Kamchatka
Asia/Karachi
Asia/Kathmandu
Asia/Khandyga
Asia/Kolkata
Asia/Krasnoyarsk
Asia/Kuala Lumpur
Asia/Kuching
Asia/Kuwait
Asia/Macau
Asia/Magadan
Asia/Makassar
Asia/Manila
Asia/Muscat
Asia/Nicosia
Asia/Novokuznetsk
Asia/Novosibirsk
Asia/Omsk
Asia/Oral
Asia/Phnom Penh
Asia/Pontianak
Asia/Pyongyang
Asia/Qatar
Asia/Qostanay
Asia/Qyzylorda
Asia/Riyadh
Asia/Sakhalin
Asia/Samarkand
Asia/Seoul
Asia/Shanghai
Asia/Singapore
Asia/Srednekolymsk
Asia/Taipei
Asia/Tashkent
Asia/Tbilisi
Asia/Tehran
Asia/Thimphu
Asia/Tokyo
Asia/Tomsk
Asia/Ulaanbaatar
Asia/Urumqi
Asia/Ust-Nera
Asia/Vientiane
Asia/Vladivostok
Asia/Yakutsk
Asia/Yangon
Asia/Yekaterinburg
Asia/Yerevan
Atlantic/Azores
Atlantic/Bermuda
Atlantic/Canary
Atlantic/Cape Verde
Atlantic/Faroe
Atlantic/Madeira
Atlantic/Reykjavik
Atlantic/South Georgia
Atlantic/St Helena
Atlantic/Stanley
Australia/Adelaide
Australia/Brisbane
Australia/Broken Hill
Australia/Darwin
Australia/Eucla
Australia/Hobart
Australia/Lindeman
Australia/Lord Howe
Australia/Melbourne
Australia/Perth
Australia/Sydney
Europe/Amsterdam
Europe/Andorra
Europe/Astrakhan
Europe/Athens
Europe/Belgrade
Europe/Berlin
Europe/Bratislava
Europe/Brussels
Europe/Bucharest
Europe/Budapest
Europe/Busingen
Europe/Chisinau
Europe/Copenhagen
Europe/Dublin
Europe/Gibraltar
Europe/Guernsey
Europe/Helsinki
Europe/Isle of Man
Europe/Istanbul
Europe/Jersey
Europe/Kaliningrad
Europe/Kirov
Europe/Kyiv
Europe/Lisbon
Europe/Ljubljana
Europe/London
Europe/Luxembourg
Europe/Madrid
Europe/Malta
Europe/Mariehamn
Europe/Minsk
Europe/Monaco
Europe/Moscow
Europe/Oslo
Europe/Paris
Europe/Podgorica
Europe/Prague
Europe/Riga
Europe/Rome
Europe/Samara
Europe/San Marino
Europe/Sarajevo
Europe/Saratov
Europe/Simferopol
Europe/Skopje
Europe/Sofia
Europe/Stockholm
Europe/Tallinn
Europe/Tirane
Europe/Ulyanovsk
Europe/Vaduz
Europe/Vatican
Europe/Vienna
Europe/Vilnius
Europe/Volgograd
Europe/Warsaw
Europe/Zagreb
Europe/Zurich
Indian/Antananarivo
Indian/Chagos
Indian/Christmas
Indian/Cocos
Indian/Comoro
Indian/Kerguelen
Indian/Mahe
Indian/Maldives
Indian/Mauritius
Indian/Mayotte
Indian/Reunion
Pacific/Apia
Pacific/Auckland
Pacific/Bougainville
Pacific/Chatham
Pacific/Chuuk
Pacific/Easter
Pacific/Efate
Pacific/Fakaofo
Pacific/Fiji
Pacific/Funafuti
Pacific/Galapagos
Pacific/Gambier
Pacific/Guadalcanal
Pacific/Guam
Pacific/Honolulu
Pacific/Kanton
Pacific/Kiritimati
Pacific/Kosrae
Pacific/Kwajalein
Pacific/Majuro
Pacific/Marquesas
Pacific/Midway
Pacific/Nauru
Pacific/Niue
Pacific/Norfolk
Pacific/Noumea
Pacific/Pago Pago
Pacific/Palau
Pacific/Pitcairn
Pacific/Pohnpei
Pacific/Port Moresby
Pacific/Rarotonga
Pacific/Saipan
Pacific/Tahiti
Pacific/Tarawa
Pacific/Tongatapu
Pacific/Wake
Pacific/Wallis
UTC
Dates
Sunday
, June 16
Monday
, June 17
Tuesday
, June 18
Wednesday
, June 19
Thursday
, June 20
Venue
Ballroom
Ballroom 20 A/ Zone 1
Ballroom 20 BC/ Zone 2
Ballroom 20 D/ Zone 3
Ballroom 20 Lobby
Ballroom 6 Lobby
Content Hub Sails Pav
Exhibit Hall
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Posters Exhibit Hall
Room 11AB
Room 14AB
Room 15AB
Room 16AB
Room 17AB
Room 1AB
Room 2
Room 5AB
Room 6A
Room 6B
Room 6C
Room 6D
Room 6E
Room 6F
Room 7AB
Room 8
Sails Pavilion
TBD
USS Midway
Session Type
00: Plenary
All
Forum
01: ClinSafety-PV
All
Forum
Session
Workshop
02: ClinTrials -ClinOps
All
Forum
Session
Workshop
03: Data-Tech
All
Forum
Session
Workshop
04: MedAffairs-SciComm
All
Forum
Session
Workshop
05: Patient-Focused Drug Dev
All
Forum
Session
Workshop
06: TranslationalDelivery Tech-PrecMedicine
All
Forum
Session
07: ProjectManagement-StrategicPlanning
All
Forum
Session
08: RD Quality-Compliance
All
Forum
Session
Tutorial
09: Regulatory
All
Forum
Session
Workshop
10: RegCMC-Product Quality
All
Forum
Session
Workshop
11: Statistics-Data Science
All
Forum
Session
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: ProfDevelopment
All
Forum
Session
Tutorial
Workshop
14: DIAmond
All
Forum
15: Content Hubs
All
Workshop
16: Community Rounds
All
Session
17: Networking Opportunities
All
Session
Social Event
Social Evt / Reception
18: Posters
All
Session
19: InnovationTheaters
All
Session
20: Short Courses
All
Tutorial
Other Filters
Format
Forum
Session
Tutorial
Workshop
Level
Advanced
Basic
Intermediate
Featured Topics
Artificial Intelligence (AI)
Cell and Gene Therapy
Decentralized Clinical Trials (DCTs)
Digital Technology
Diversity Equity and Inclusion (DEI)
Ethics
ICH
Patient Focused
Rare Disease
Real-World Data (RWD)- Real-World Evidence (RWE)
Regulator Perspectives
Regulatory Collaboration
Regulatory Reliance
Risk Management
Special Populations
Student Programming