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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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Advanced Therapies
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Precision Medicine
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Regulator Thinking
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09: Regulatory
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Sunday
, June 23
9:00am PDT
SC21: #21: Basics of European Medical Device Regulation
Room 2
SC23: #23: Preparing for a US FDA Advisory Committee Meeting
Room 6E
SC42: #42: Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision Making
Room 11B
SC43: #43: Back to the Future: Combination Products in the 21st Century
Room 9
1:30pm PDT
SC30: #30: Machine Learning in Pharmacovigilance
Room 5AB
SC33: #33: European Regulatory Meetings: How Best to Prepare and Perform
Room 6E
SC35: #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Room 4
Monday
, June 24
11:00am PDT
#106: Moving Forward in EU Pharmacovigilance
Room 6C
#116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs
Room 6F
#117: International Regulatory Convergence
Room 6B
2:15pm PDT
#136: Interpretation of New Pharmacovigilance Regulations: Key Insights
Room 6C
#146: Communications with Regulators Beyond Formal Meetings
Room 6B
#147: Update from Health Canada: The Health Protection Branch
Room 6F
#148: Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?
Room 6E
#149: Hype Versus Reality: Artificial Intelligence and Drug Development
Room 11B
#150: TFDA Town Hall: Focus on Regenerative Medicine
Room 14B
3:30pm PDT
#165: Drug Development Tools in a Digital Era
Room 6F
#166: Updates on China Regulatory Reform
Room 6E
#167: Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry
Room 6B
Tuesday
, June 25
8:00am PDT
#208: Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges
Room 5AB
#213: Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases
Room 6B
#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
#215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges
Room 6E
#218: Real World Data to Real World Evidence
Room 3
#219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?
Room 14B
10:30am PDT
#229: An Industry Collaboration on Pharmacovigilance Analytics
Room 6C
#240: Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)
Room 6F
#241: PMDA Town Hall
Room 6E
#242: Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project
Room 6B
#243: The Future of Combination Products in the EU
Room 16AB
11:45am PDT
#250 CH: How to Efficiently Implement a Healthcare Compliance Program in Preparation for Your First Product Launch
Content Hub Sails Pav
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
#269: Driving Complex Generics to Approval: What are the Keys to Success
Room 6F
3:15pm PDT
#275 EE: Access to Investigational Drugs Outside of Clinical Trials: What's Fair?
E and E Area Exh Hall
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
#299: Public and Regulatory Response To Drug Pricing Concerns
Room 14B
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
#341: The Evolving Gene Therapy Regulatory Framework: A Brave New World
Room 6E
#342: When is Real World Evidence Ready for Prime Time?
Room 6D
#339: Hot Topics in Quality and Regulatory Affairs for Combination Products
Room 6B
#343: Efficient Preparation of Global CMC Dossiers
Room 8
12:30pm PDT
#349 EE: Regulatory Affairs Governance: Benchmarking and Sharing of Best Practices
E and E Area Exh Hall
1:15pm PDT
#353 CH: The Current and Future State of RIM
Content Hub Sails Pav
2:00pm PDT
#367: Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?
Room 6B
#368: Global Rare Disease Town Hall
Room 6F
#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
#391: Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies
Room 16AB
#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
#389: Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines?
Room 6B
#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