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DIA 2019 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-Data Standards
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04: MedAffairs-SciComm
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05: Patient Engagement
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06: PreClin Dev-EarlyPhaseCR
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07: ProjMgt-StrategicPlanning
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08: R-D 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: 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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Featured Topics
Advanced Therapies
Artificial Intelligence
Generics
Innovative Trial Design
Patient Focused
Precision Medicine
Rare Disease
Real World Evidence
Regulator Thinking
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09: Regulatory, Session
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Monday
, June 24
11:00am PDT
#116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs
Room 6F
2:15pm PDT
#146: Communications with Regulators Beyond Formal Meetings
Room 6B
#149: Hype Versus Reality: Artificial Intelligence and Drug Development
Room 11B
3:30pm PDT
#165: Drug Development Tools in a Digital Era
Room 6F
Tuesday
, June 25
8:00am PDT
#214: Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?
Room 6F
#216: Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs
Room 11B
#218: Real World Data to Real World Evidence
Room 3
10:30am PDT
#240: Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)
Room 6F
#242: Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project
Room 6B
2:00pm PDT
#263: Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives
Room 6D
#268: Current Status of FDA Framework for the Evaluation of Real World Evidence
Room 6B
4:15pm PDT
#295: Prescription Drug Labeling: New Guidances from the US FDA
Room 6B
#296: Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence
Room 6E
#294: Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education
Room 6F
Wednesday
, June 26
8:00am PDT
#301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment
Room 6C
#309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities
Room 2
#314: Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?
Room 6F
#313: Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why
Room 6E
10:30am PDT
#340: Digital Technology Advances Labeling Management and Patient Access
Room 6F
#339: Hot Topics in Quality and Regulatory Affairs for Combination Products
Room 6B
#343: Efficient Preparation of Global CMC Dossiers
Room 8
2:00pm PDT
#369: User-Fee Programs Myth Busting: General Financial Principles Explained
Room 6E
4:15pm PDT
#388: Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products
Room 6F
#392: Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry
Room 6D
#390: Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints
Room 6E
#396: Challenges to Access: Bringing Payers to the Table
Room 14B
Thursday
, June 27
9:00am PDT
#410: Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics
Room 6F
Timezone
DIA 2019 Global Annual Meeting
America/Los Angeles
Filter By Date
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
Filter By Venue
San Diego, CA, USA
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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
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
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
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
All
Forum
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
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
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Dates
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
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
All
Forum
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
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