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01 - Clinical Safety and Pharmacovigilance
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06 - Translational Sciences and Precision Medicine
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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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AI and Machine Learning
COVID-19
Data Science
Decentralized Trials
Digital
Diversity Equity and Inclusion
Innovative Trial Design
Patient Perspective
Personalized Health Care
Regulator Perspective
Remote Work
RWD-RWE
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Tuesday
, June 27
8:30am CDT
Illuminating Risk Minimization Effectiveness Measurement
TBD
Ethical Considerations for Conducting Research During Times of Disruption
TBD
Innovating Patient Recruitment Through Pharmacy Channels
TBD
ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange
TBD
The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives
TBD
Innovation Across Medical Affairs Throughout the Global Pandemic
TBD
Leveraging Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making
TBD
International Regulatory Convergence and Collaboration
TBD
Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed?
TBD
Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall
TBD
10:30am CDT
Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report
TBD
Good Recruitment Practice Under Regulation (EU) No 536/2014
TBD
The Future of Regulatory Submissions: Opportunities and Challenges
TBD
Medical Storytelling Inserted Into All Aspects of Medical Affairs
TBD
Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity
TBD
The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases
TBD
IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback
TBD
ANVISA Townhall
TBD
International Harmonization of Real-World Data/Real-World Evidence Use and Acceptance by Health Authorities: Time to Make it Right!
TBD
Patient Experience Data in the Label: Closing the Loop
TBD
Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment
TBD
A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines
TBD
The Full Picture: Innovative Software Tools for Data Insight Generation
TBD
Is Mark Cuban Really Solving the Drug Pricing Problem?
TBD
1:15pm CDT
Novel Methods for Signal Identification for Medicines and Medical Devices
TBD
Hot off the Press: Site Challenges and Solutions in Workforce and Technology
TBD
Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape
TBD
Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives
TBD
Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!)
TBD
Measuring Impact of Patient Engagement Across Research and Development
TBD
Using Artificial Intelligence to Illuminate Predictive Relationships and Discover Biomarkers from Clinical, Molecular, and Digital Data
TBD
Getting Things Done in Drug Development Using Agile Practices
TBD
Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections
TBD
Asia Town Hall
TBD
Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions
TBD
One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot!
TBD
Quality in the Real World: Diagnosing and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data
TBD
The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives?
TBD
Demystifying the Common Legal Agreements, Key Terms, and Pitfalls for Non-Legal Professionals
TBD
4:00pm CDT
Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way?
TBD
Smarter Approaches to Pharmacovigilance Challenges
TBD
Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers and Clinical Care?
TBD
The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials
TBD
IDMP and Data Harmonization Methods: How Your Company will be Impacted
TBD
SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data
TBD
Generating Patient Insights to Inform Health Policy Issues: Policy Patient Engagement Research Councils (PERCs)
TBD
An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward?
TBD
Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation
TBD
Globally Accelerating the Drive to eLabeling for All
TBD
PMDA Town Hall
TBD
Quality Aspects of FY23-28 User Fee Agreements
TBD
Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology
TBD
Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions
TBD
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00: Plenary
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01 - Clinical Safety and Pharmacovigilance
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01: ClinSafety-PV
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02: ClinTrials -ClinOps
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03: Data-Tech in Clinical Trials
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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/Kiev
Europe/Kirov
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/Uzhgorod
Europe/Vaduz
Europe/Vatican
Europe/Vienna
Europe/Vilnius
Europe/Volgograd
Europe/Warsaw
Europe/Zagreb
Europe/Zaporozhye
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/Enderbury
Pacific/Fakaofo
Pacific/Fiji
Pacific/Funafuti
Pacific/Galapagos
Pacific/Gambier
Pacific/Guadalcanal
Pacific/Guam
Pacific/Honolulu
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 13
Tuesday
, June 14
Wednesday
, June 15
Thursday
, June 16
Monday
, June 20
Tuesday
, June 21
Wednesday
, June 22
Thursday
, June 23
Monday
, June 12
Tuesday
, June 13
Wednesday
, June 14
Monday
, June 26
Tuesday
, June 27
Wednesday
, June 28
Thursday
, June 29
Venue
Exh Hall Community Area
Exhibit Hall
Exhibit Hall Booth #1719
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Level 3 F2 Entrance
Meeting Rm Lobby Level 1
Meeting Room Lobby
Room 175
Room 176
Room 178
Room 179
Room 180
Room 183 A
Room 183 B
Room 183 C
Room 184
Room 185 AB
Room 185 CD
Room 186
Room 187
Room 375 A Zone 1
Room 375 A Zone 2
Room 470 A
Room 470 B
Room 471 A
Room Skyline 375 CDE
Skyline Ballroom Foyer
TBD
Virtual
Session Type
00: Plenary
All
Forum
01 - Clinical Safety and Pharmacovigilance
All
Tutorial
01: ClinSafety-PV
All
Forum
Session
Tutorial
Workshop
02: ClinTrials -ClinOps
All
Forum
Session
Tutorial
Workshop
03: Data-Tech in Clinical Trials
All
Forum
Session
Workshop
04: MedAffairs-SciComm
All
Forum
Session
Workshop
05: Patient Engagement
All
Forum
Session
Workshop
06: PreClinical Dev-EarlyPhaseCR
All
Forum
Session
Workshop
06 - Translational Sciences and Precision Medicine
All
Tutorial
06: TranslationalScience-PrecisionMedicine
All
Forum
Session
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
15: Content Hubs
All
Workshop
16: Community Rounds
All
Session
17: Networking Opportunities
All
Forum
Session
Social Event
18: Posters
All
Poster Presentation
19: InnovationTheaters
All
Session
20: Short Courses
All
Tutorial
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Advanced
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Featured Topics
AI and Machine Learning
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Remote Work
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