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DIA 2018 Global Annual Meeting
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DIA 2018 Global Annual Meeting
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00: Plenary
All
Session
01: ClinSafety-PV
All
Forum
Session
02: ClinTrials -ClinOps
All
Forum
Session
Workshop
03: Data-Data Standards
All
Session
Workshop
04: MedAffairs-SciComm
All
Forum
Session
05: Patient Engagement
All
Forum
Session
06: PreClin Dev-EarlyPhaseCR
All
Forum
Session
07: ProjMgt-StrategicPlanning
All
Forum
Session
Workshop
08: R and D Quality-Compliance
All
Forum
Session
Workshop
09: Regulatory
All
Forum
Session
10: RegCMC-Product Quality
All
Forum
Session
Workshop
11: Statistics
All
Session
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: DIAmond
All
Forum
14: InnovTheater
All
Session
15: Engage-Exchange
All
Workshop
16: Content Hubs
All
Session
17: Community Rounds
All
Forum
18: ProfDevelopment
All
Forum
Session
Workshop
19: Posters
All
Poster Presentation
Networking-CommunityEvents
All
Social Event
Short Course
All
Tutorial
Level
Advanced
Beginner
Intermediate
Featured Topics
Biomarkers - Diagnostics
Biosimilars
Career Development
Devices and Combination Products
ExUS Regulatory
Gene Therapy
Generics
Mobile Technology
Outsourcing
Pediatrics
Rare Diseases
Real World Evidence
Regulatory Agency Presenters
Translational Science and Medicine
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Tuesday
, June 26
8:00am EDT
#202: Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality
Room 257AB
#203: Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials
Room 258AB
#207: Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges
Room 156ABC
#209: Oversight in the Era of E6 (R2)
Room 205C
#201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin
Room 253AB
#204: FDA Data Standards Update
Room 209
#205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients
Room 210C
#206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making
Room 151AB
#208: Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry
Room 153ABC
#210: Artificial Intelligence: The Future of Regulatory Affairs
Room 206AB
#211: Update on Collaboration and Trends in Global Companion Diagnostics
Room 208
#212: Global Regulatory Strategies for Biosimilars
Room 204AB
#213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry
Room 205AB
#214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs
Room 253C
#216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome?
Room 258C
10:30am EDT
#228: Global Clinical Trials: Lessons in Effective Execution
Room 258AB
#236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat?
Room 205C
#237: Expanded Access: Where Are We Now?
Room 206AB
#227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible
Room 257AB
#229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments
Room 258C
#230: Common Data Model Harmonization for Evidence Generation
Room 208
#233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives
Room 151AB
#234: Personalized Medicine Approaches During Early-Phase Clinical Research
Room 156ABC
#235: The Adventures of Patient Experience in Drug Development
Room 252AB
#238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer?
Room 204AB
#239: Generic Drug Town Hall
Room 205AB
#240: Biosimilars: Demonstrating Structural and Functional Similarity
Room 253C
#241: Time-to-Event Analysis in Clinical Trials
Room 256
#242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date
Room 153ABC
#243: Global Perspectives on Patient Engagement
Room 210AB
12:00pm EDT
#244: Yes, No, Maybe: Sharing Health and Other Data for Research - Enthusiasm and Concern from the Patient Community
E and E Exhibit Hall
1:15pm EDT
#249: Global Evolution in Regulatory Science and Medicine: Novel Modalities and Intersection with Rare Disease Development
E and E Exhibit Hall
1:30pm EDT
#250: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials
Content Hub NE Lobby
2:00pm EDT
#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations
Room 208
#260: Optimizing Clinical Development With Adaptive Trial Designs
Room 156ABC
#267: Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care
Room 252AB
#252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection
Room 257AB
#253: Digitizing a Patient-Focused Clinical Trial Experience
Room 258AB
#254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go
Room 258C
#256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries
Room 210C
#257: Globalizing and Regionalizing Medical Information Contact Centers
Room 209
#258: Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels
Room 151AB
#259: Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask
Room 254AB
#262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan
Room 205C
#263: Navigating the Regulatory Landscape of Drug-Device Combination Products
Room 204AB
#264: Global Development Using Expedited Pathways in Established and Emerging Markets
Room 206AB
#265: ICH M9 BCS-Based Biowaivers
Room 253C
#268: Future of PharmaTech
Room 210AB
4:15pm EDT
#284: Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials
Room 151AB
#288: Is It Time to Change the Content and Format of Labeling?
Room 205AB
#277: Pharmacovigilance: No Longer Going it Alone
Room 253C
#278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring
Room 252AB
#279: Redefining the Site Investigator's Experience
Room 153ABC
#280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers
Room 254AB
#281: Future of Endpoints
Room 258C
#282: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials
Room 209
#283: Evolving Roles and Responsibilities for Medical Affairs Professionals
Room 210C
#285: Gene Therapy: Advances in Translating Technology
Room 156ABC
#286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How?
Room 157AB
#287: The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team
Room 205C
#289: Electronic Submissions Demystified
Room 204AB
#291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?
Room 208
#292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs
Room 256
Timezone
DIA 2018 Global Annual Meeting
America/New York
Filter By Date
DIA 2018 Global Annual Meeting
Jun 24
-
28, 2018
Sunday
, June 24
Monday
, June 25
Tuesday
, June 26
Wednesday
, June 27
Thursday
, June 28
Filter By Venue
Boston, MA, United States
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Ballroom
Ballroom Lobby 3
Commonwealth Room Westin
Community Zone NE Lobby
Content Hub NE Lobby
DIA Booth #1519 Exh Hall
E and E Exhibit Hall
Exhibit Hall
North Lobby
Posters Exhibit Hall
Room 151AB
Room 153ABC
Room 156ABC
Room 157AB
Room 157C
Room 158
Room 159
Room 160A
Room 160B
Room 160C
Room 161
Room 162A
Room 162B
Room 204AB
Room 205AB
Room 205C
Room 206AB
Room 208
Room 209
Room 210AB
Room 210C
Room 252AB
Room 253AB
Room 253C
Room 254AB
Room 256
Room 257AB
Room 258AB
Room 258C
Theater 1 Exhibit Hall
Theater 2 Exhibit Hall
Filter By Type
00: Plenary
All
Session
01: ClinSafety-PV
All
Forum
Session
02: ClinTrials -ClinOps
All
Forum
Session
Workshop
03: Data-Data Standards
All
Session
Workshop
04: MedAffairs-SciComm
All
Forum
Session
05: Patient Engagement
All
Forum
Session
06: PreClin Dev-EarlyPhaseCR
All
Forum
Session
07: ProjMgt-StrategicPlanning
All
Forum
Session
Workshop
08: R and D Quality-Compliance
All
Forum
Session
Workshop
09: Regulatory
All
Forum
Session
10: RegCMC-Product Quality
All
Forum
Session
Workshop
11: Statistics
All
Session
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: DIAmond
All
Forum
14: InnovTheater
All
Session
15: Engage-Exchange
All
Workshop
16: Content Hubs
All
Session
17: Community Rounds
All
Forum
18: ProfDevelopment
All
Forum
Session
Workshop
19: Posters
All
Poster Presentation
Networking-CommunityEvents
All
Social Event
Short Course
All
Tutorial
Level
Advanced
Beginner
Intermediate
Featured Topics
Biomarkers - Diagnostics
Biosimilars
Career Development
Devices and Combination Products
ExUS Regulatory
Gene Therapy
Generics
Mobile Technology
Outsourcing
Pediatrics
Rare Diseases
Real World Evidence
Regulatory Agency Presenters
Translational Science and Medicine
Filter sessions
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Dates
Sunday
, June 24
Monday
, June 25
Tuesday
, June 26
Wednesday
, June 27
Thursday
, June 28
Venue
Ballroom
Ballroom Lobby 3
Commonwealth Room Westin
Community Zone NE Lobby
Content Hub NE Lobby
DIA Booth #1519 Exh Hall
E and E Exhibit Hall
Exhibit Hall
North Lobby
Posters Exhibit Hall
Room 151AB
Room 153ABC
Room 156ABC
Room 157AB
Room 157C
Room 158
Room 159
Room 160A
Room 160B
Room 160C
Room 161
Room 162A
Room 162B
Room 204AB
Room 205AB
Room 205C
Room 206AB
Room 208
Room 209
Room 210AB
Room 210C
Room 252AB
Room 253AB
Room 253C
Room 254AB
Room 256
Room 257AB
Room 258AB
Room 258C
Theater 1 Exhibit Hall
Theater 2 Exhibit Hall
Session Type
00: Plenary
All
Session
01: ClinSafety-PV
All
Forum
Session
02: ClinTrials -ClinOps
All
Forum
Session
Workshop
03: Data-Data Standards
All
Session
Workshop
04: MedAffairs-SciComm
All
Forum
Session
05: Patient Engagement
All
Forum
Session
06: PreClin Dev-EarlyPhaseCR
All
Forum
Session
07: ProjMgt-StrategicPlanning
All
Forum
Session
Workshop
08: R and D Quality-Compliance
All
Forum
Session
Workshop
09: Regulatory
All
Forum
Session
10: RegCMC-Product Quality
All
Forum
Session
Workshop
11: Statistics
All
Session
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: DIAmond
All
Forum
14: InnovTheater
All
Session
15: Engage-Exchange
All
Workshop
16: Content Hubs
All
Session
17: Community Rounds
All
Forum
18: ProfDevelopment
All
Forum
Session
Workshop
19: Posters
All
Poster Presentation
Networking-CommunityEvents
All
Social Event
Short Course
All
Tutorial
Other Filters
Level
Advanced
Beginner
Intermediate
Featured Topics
Biomarkers - Diagnostics
Biosimilars
Career Development
Devices and Combination Products
ExUS Regulatory
Gene Therapy
Generics
Mobile Technology
Outsourcing
Pediatrics
Rare Diseases
Real World Evidence
Regulatory Agency Presenters
Translational Science and Medicine