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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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04: MedAffairs-SciComm
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05: Patient Engagement
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06: TranslationalScience-PrecisionMedicine
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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
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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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20: Short Courses
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Featured Topics
Artificial Intelligence (AI)
Benefit - Risk
Cell and Gene Therapy
Decentralized Clinical Trials (DCTs)
Digital Technology
Diversity Equity and Inclusion (DEI)
Dose Optimization
Endpoints
Ethics
Patient Focused
Rare Disease
Real-World Data (RWD) - Real-World Evidence (RWE)
Regulator Thinking
Regulatory Collaboration
Student Programming
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09: Regulatory, Session
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Monday
, June 26
10:45am EDT
#110: Disruptive Medicine Innovation: Combination Products
Room 153 AB
#114: Navigating the Constellation of Efforts to Increase Representation in Clinical Research
Room 210
#111: E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards and Examples of use of Estimands
Room 102
#106: New Alternative Methods-Only IND/CTA Application: Distant Dream or Immediate Possibility?
Room 253 C
#109: Cell and Gene Therapies Pulse Check
Room 156
1:30pm EDT
#130: On the Path to Enlightened Conversations: Setting up Structured Content Authoring
Room 253 C
4:15pm EDT
#158: Emerging Therapies and Technologies: Leveraging Opportunities for Engaging in Pre-Competitive Research and with Medicine Regulators to Support Innovation
Room 153 AB
#160: Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role
Room 104 AB
#161: Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence
Room 151
Tuesday
, June 27
8:30am EDT
#204: ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange
Room 206
#205: The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives
Room 253 A
#136: WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening
Room 205 A
#209: International Regulatory Convergence and Collaboration
Room 153 AB
#210: Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed?
Room 157 AB
10:30am EDT
#217: Good Recruitment Practice Under Regulation (EU) No 536/2014
Room 254
#224: Time for Alignment? A Policy Landscape Update on the Use and Acceptance of Real-World Data/Real-World Evidence for Regulatory Purposes
Room 153 AB
#226: Patient Experience Data in the Label: Closing the Loop
Room 157 AB
#228: A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines
Room 151
1:15pm EDT
#245: Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives
Room 206
#251: Asia Town Hall
Room 153 AB
#252: One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot!
Room 151
4:00pm EDT
#270: SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data
Room 206
#271: IDMP Standards, Structured Submissions, and Data Harmonization Methods: How Will Your Company be Impacted?
Room 253 A
#276: Globally Accelerating the Drive to eLabeling for All
Room 156
#277: Quality and CMC Aspects of Recent US Legislation: Challenges and Opportunities
Room 151
#275: PMDA Town Hall
Room 153 AB
Wednesday
, June 28
8:30am EDT
#306: Writing Summary Documents for Rare Disease Submissions: Unique Challenges
Room 253 C
10:30am EDT
#317: Leveraging Data Scientists and Data Managers in Clinical Data Management
Room 206
#321: What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)?
Room 204
#322: PI 1572 Responsibility and Oversight in Decentralized Clinical Trials
Room 253 B
#323: 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness?
Room 153 AB
#326: Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains
Room 151
#327: Patient-Focused Drug Development in Rare Disease Endpoint Selections
Room 102
11:45am EDT
#332: Roundtable Discussion: Strategies for Benefit-Risk Analysis in Regulatory Submissions
Grand Ballroom Zone 3
1:15pm EDT
#340: Regulatory Insights into Decentralized Clinical Trials
Room 254
#348: The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act
Room 156
#342: Real-World Data Standards and Protocol Designs for Information Exchange and Data Flow
Room 253 A
#349: Evolving Global Landscape for Addressing Drug Shortages: Innovative Technology and Regulatory Strategies
Room 151
4:00pm EDT
#363: Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation
Room 253 A
#370: Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally
Room 156
#371: ICH Work to Harmonize Requirements for Safe and Effective Medicines: What’s in It for Patients?
Room 157 AB
Thursday
, June 29
8:30am EDT
#404: Implementation of the New EU Clinical Trials Regulation
Room 253 C
#408: FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings
Room 153 AB
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DIA 2023 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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Featured Topics
Artificial Intelligence (AI)
Benefit - Risk
Cell and Gene Therapy
Decentralized Clinical Trials (DCTs)
Digital Technology
Diversity Equity and Inclusion (DEI)
Dose Optimization
Endpoints
Ethics
Patient Focused
Rare Disease
Real-World Data (RWD) - Real-World Evidence (RWE)
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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
Monday
, June 12
Tuesday
, June 13
Wednesday
, June 14
Sunday
, June 25
Monday
, June 26
Tuesday
, June 27
Wednesday
, June 28
Thursday
, June 29
Venue
Ballroom Lobby 3
Content Hub NE Lobby
DIA Booth #539 EH
Exhibit Hall
Exhibit Hall Entrance
Exhibit Hall South
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Grand Ballroom
Grand Ballroom Zone 1
Grand Ballroom Zone 2
Grand Ballroom Zone 3
Grand Ballroom Zone 3A
Grand Ballroom Zone 3B
North Lobby
Outside Room 210
Room 102
Room 104 AB
Room 151
Room 153 AB
Room 156
Room 157 AB
Room 157C
Room 204
Room 205 A
Room 205 BC
Room 206
Room 210
Room 252
Room 253 A
Room 253 B
Room 253 C
Room 254
Virtual
Session Type
00: Plenary
All
Forum
01: ClinSafety-PV
All
Forum
Session
Tutorial
Workshop
02: ClinTrials -ClinOps
All
Forum
Session
Workshop
03: Data-Tech
All
Forum
Session
Tutorial
Workshop
04: MedAffairs-SciComm
All
Forum
Session
Workshop
05: Patient Engagement
All
Forum
Session
Workshop
06: TranslationalScience-PrecisionMedicine
All
Forum
Session
Tutorial
07: ProjectManagement-StrategicPlanning
All
Forum
Session
Workshop
08: RD Quality-Compliance
All
Forum
Session
Tutorial
Workshop
09: Regulatory
All
Forum
Session
Tutorial
Workshop
10: RegCMC-Product Quality
All
Forum
Session
11: Statistics
All
Forum
Session
Tutorial
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: ProfDevelopment
All
Forum
Session
Workshop
14: DIAmond
All
Forum
Session
15: Content Hubs
All
Workshop
16: Community Rounds
All
Session
17: Networking Opportunities
All
Session
Social Event
Workshop
18: Posters
All
Session
19: InnovationTheaters
All
Session
20: Short Courses
All
Tutorial
Other Filters
Level
Advanced
Basic
Intermediate
Featured Topics
Artificial Intelligence (AI)
Benefit - Risk
Cell and Gene Therapy
Decentralized Clinical Trials (DCTs)
Digital Technology
Diversity Equity and Inclusion (DEI)
Dose Optimization
Endpoints
Ethics
Patient Focused
Rare Disease
Real-World Data (RWD) - Real-World Evidence (RWE)
Regulator Thinking
Regulatory Collaboration
Student Programming