This event has ended. Visit the
official site
or
create your own event on Sched
.
DIA 2016 Annual Meeting
Add Sunday
Tutorials
.
Eighteen options to choose from! Space is limited. Pre-registration required.
DIAmond Sessions
—NEW!
Download the
DIA Global App
CISCRP Medical Heroes Appreciation 5K
.
Starts Monday, bright and early!
Sunday Networking Session
.
Limited seating available.
RSVP requested
.
View
Professional and Student Poster details
View
Final Program
Schedule
Simple
Expanded
Grid
By Venue
Speakers
Networking
Search
or browse by date + venue
Preconference Tutorial
All
Tutorial
Trk 01: Clinical Operations
All
Forum
Session
Symposium
Tutorial
Workshop
Trk 02: Proj-Port Mgt-Strat Planning
All
Forum
Session
Workshop
Trk 02: Proj/Port Mgt/Strat Planning
All
Forum
Trk 03: Innov Part Model-Outsourcing
All
Forum
Session
Symposium
Trk 03: Innov Part Model/Outsourcing
All
Session
Trk 04: Preclin Transl-Early Clin Dev
All
Forum
Session
Symposium
Trk 05: Reg of Prod Adv-Mkting
All
Forum
Session
Trk 05: Reg of Prod Adv/Mkting
All
Forum
Session
Trk 06: Med Comm-Wrtg-MSL
All
Session
Symposium
Trk 06: Med Comm/Wrtg/MSL
All
Session
Trk 07: Tech-Data- Records-Subs
All
Forum
Session
Symposium
Trk 07: Tech/Data/ Records/Subs
All
Forum
Session
Symposium
Trk 08: Reg Affairs
All
Forum
Session
Tutorial
Trk 09: Med Devices-InVitro-CombProd
All
Forum
Session
Trk 09: Med Devices/InVitro/CombProd
All
Session
Trk 10: Pub Pol-HealthCare Compl-Law
All
Forum
Session
Tutorial
Trk 10: Pub Pol/HealthCare Compl/Law
All
Forum
Session
Trk 11: Quality in CT-GCP
All
Forum
Session
Tutorial
Trk 11: Quality in CT/GCP
All
Session
Trk 12: Pharm Quality
All
Forum
Session
Trk 13: CER-Glob Health Econ
All
Forum
Session
Tutorial
Trk 13: CER/Glob Health Econ
All
Forum
Session
Trk 14: Clin Safety-PV
All
Forum
Session
Tutorial
Trk 14: Clin Safety/PV
All
Session
Trk 15: Statistics
All
Forum
Session
Tutorial
Trk 16: Prof Development
All
Forum
Session
Tutorial
Workshop
Trk 17: Rare-Orphan Diseases
All
Forum
Session
Symposium
Tutorial
Trk 17: Rare/Orphan Diseases
All
Session
Trk 18: Global Regulatory
All
Forum
Session
Trk 19: DIAmond
All
Forum
Trk 20: Innov Theater
All
Session
Trk 21: Poster Presentations
All
Poster Presentation
Trk 22: Engage and Exchange
All
Workshop
Trk 23: Opening Plenary
All
Session
Credit Type
ACPE
CME
IACET
PMI
RN
Audience
Advanced
Basic
Intermediate
Featured Topics
21st Century Cures
Agency Participation
Approval Pathways
Audits and Inspections
Benefit-Risk
Big Data
Biologics-Biosimilars
Clinical Trial Designs
Clinical Trial Transparency-Clinical Trial Disclos
Cloud Computing
Community-led-Scientific Working Group Offerings
Current Issues in Policy and Law
Design Thinking
Disease Specific
Disruptive Technologies
Electronic Health Records (EHR)
Emerging Markets
GDUFA-Generics
Hot Topics in Policy and Law
IDMP
Increasing Research and Development Innovation
Interactive Workshop
Labeling
Mobile-Wearable Technology
Observational Studies
Partnership Strategies
Patient Engagement
Patient Recruitment and Retention
Patient Registries
Pediatrics
Precision-Personalized Medicine-Targeted Therapy
Pricing- Reimbursement and Access
Program Offerings for Student Attendees
R&D Innovation
Regulatory Harmonization-Convergence
Risk Evaluation and Mitigation Strategies (REMS)
Risk-Based Monitoring
Social Media Strategies
Topics Related to Asia-Pacific Region
Topics Related to Canada
Topics Related to China
Topics Related to Europe-EMEA
Topics Related to India
Topics Related to Japan
Vaccines
Value-Based Evidence
Women's Health
Interest Area
Academic Health Centers-Investigative Sites
Advertising & Promotion
Biotechnology
Clinical Data Management
Clinical Data Management - eClinical
Clinical Research
Clinical Safety & Pharmacovigilance
Clinical Supplies
CMC
CMC-GMP
Combination Products
Comparative Effectiveness
Document & Records Management
eClinical
Finance
Good Clinical Practices & QA
Information Technology
Manufacturing
Marketing & Sales
Medical Communications
Medical Devices & Diagnostics
Medical Science Liaison
Medical Writing
Non-clinical Safety
Outsourcing
Patient Engagement
Pharmaceutics
Pricing - Reimbursement
Professional Education - Training & Development
Project Management
Public Policy - Health Care Compliance - Law
Public Policy - Law
QA-QC
Quality Assurance - Quality Control
R&D - Strategic Issues
Rare - Orphan Diseases
Regulatory Affairs
Statistics
Strategic Planning
Study Endpoints
Submissions
Val - Electronic Info Integrity
Popular
Sign up
or
log in
to bookmark your favorites and sync them to your phone or calendar.
menu
Menu
Schedule
Speakers
Networking
Search
tune
Filter sessions
Simple
Expanded
Grid
By Venue
Interest Area:
Regulatory Affairs
[
clear filter
]
Sunday
, June 26
8:30am EDT
#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
102AB
#24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China
104AB
#20: The Sunshine Act: Understanding the Essentials of Compliance
107AB
#23: How to Prepare for an FDA Inspection
103A
9:00am EDT
#43: Risk Management and Safety Communication Strategies
113B
#44: The Good Pharmacovigilance Practices in the EU: Global Applications
113C
#40: Analysis of Safety Data from Clinical Trials
111AB
1:00pm EDT
#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
102AB
#31: Preparing for a US FDA Advisory Committee Meeting
103A
#34: Ethical Issues in Clinical Trials
104AB
Monday
, June 27
8:30am EDT
#102: Digital Health Debate
113A
#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
105AB
#105: Maximize the Value of Your Product by Beginning with the End in Mind
107AB
#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?
203AB
#109: EHR in Clinical Research: Heralding a New Era
201C
#110: Updates and Pending Issues in the US Biosimilar Environment
201B
#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?
204B
10:45am EDT
#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America
113B
#124: Risk-Based Monitoring in Clinical Trials
113C
#131: IDMP Update
204B
#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!
201B
#138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices
109AB
#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements
108A
1:00pm EDT
#148: PAREXEL Innovation Theater: Balancing Rapid Approval with Demonstration of Value
Exhibit Hall B
1:30pm EDT
#149: EMA's Publication Policy 0070: Best Practices for Implementation
Exhibit Hall A
Tuesday
, June 28
8:00am EDT
#201: International Regulatory Convergence, Collaboration, and Cooperation
114
10:30am EDT
#207: Advancing the Appropriate Use of Mobile Clinical Trials: The Clinical Trials Transformation Initiative
108A
#213: FDA Enforcement Update: Advertising and Promotion
107AB
#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
201B
#220: Regulatory Changes in China and the Impact to Global Drug Development Planning
109AB
#227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development
103C
#217: Electronic Submissions Gateway: Next Generation
201C
#216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step
204C
#219: Regulatory Science Considerations Applying to Novel Combinations of Biologics and Bifunctional Biologics Development
204B
#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment
103A
#223: Global Harmonization: Current ICH Quality Initiatives
112AB
1:20pm EDT
#233: Veeva Innovation Theater: The Great RIM Throwdown! How Are You Managing Regulatory Events?
Exhibit Hall B
2:00pm EDT
#237: Acquisitions and Mergers: When Companies’ Regulatory Operations Systems and Processes Converge
112AB
#252: Capturing Real-World Data in Rare Diseases
103C
#253: Update from Health Canada
202AB
#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations
108B
#238: Prescription Drug Marketing Regulatory Primer
107AB
#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
201B
#242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology
108A
#254: CBER Town Hall: State of the Center and Plans for the Future
203AB
4:00pm EDT
#259: Innovative Regulatory Solutions: Utilizing Flexible Outsourcing Strategies
112AB
#261: Marketing After Amarin and Pacira
107AB
#264: FDA Update on Data Standards
204B
#266: Perspectives on Expanded Access to Investigational New Drugs
108A
#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
105AB
#273: Improving Adverse Drug Reaction Information in Product Labels
109AB
#277: PMDA Town Hall
202AB
Wednesday
, June 29
8:00am EDT
#302: Europe and the US: Making Outcomes-Based Health Care Possible
114
10:30am EDT
#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
113C
#314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End
203AB
#327: FDA–Health Canada Regulatory Cooperation Council Town Hall
201C
#309: Global Stakeholder Management: Across the Ocean Between East and West
105AB
#313: The Future of Clinical Research Data: 2020 and Beyond
204B
#315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My!
201B
#316: What’s Your Preference? The Emerging Importance of Patient Preference Elicitation
204C
#317: Global Medical Device Development: Regulatory Concordance or Discordance?
103C
#321: Office of Pharmaceutical Quality Update
113B
2:00pm EDT
#341: eTMF: Selection, Implementation, and What's Next?
204B
#337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools
112AB
#339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them
203AB
#342: Big Data in Health Care and Life Sciences
201C
#340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research
204C
#343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape
201B
#347: Global Harmonization: Non-ICH Regions
111AB
4:00pm EDT
#357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects
108B
#362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders
204C
#363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines
201B
#364: Cell and Gene Therapies: Current Global Landscape
204B
#366: Infectious Disease Containment and Lessons Learned
202AB
Thursday
, June 30
9:00am EDT
#401: EMA/FDA Question Time
114
10:45am EDT
#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
111AB
#408: Securing Internet-Driven Collaboration in Drug Development
109AB
#403: Running Personalized Medicine Trials: Facts and Figures
108B
#412: CDER Town Hall
114
Timezone
DIA 2016 Annual Meeting
America/New York
Filter By Date
DIA 2016 Annual Meeting
Jun 25
-
30, 2016
Saturday
, June 25
Sunday
, June 26
Monday
, June 27
Tuesday
, June 28
Wednesday
, June 29
Thursday
, June 30
Filter By Venue
Philadelphia, PA, United States
Sort schedule by Venue
102AB
103A
103ABC
103C
104A
104AB
105AB
107AB
108A
108B
109AB
111AB
112AB
113A
113B
113C
114
201A
201B
201C
202AB
203AB
204A
204B
204C
Ballroom A
Ballroom AB
Exhibit Hall
Exhibit Hall A
Exhibit Hall B
Liberty Ballroom A
TBA
TBD
Filter By Type
Preconference Tutorial
All
Tutorial
Trk 01: Clinical Operations
All
Forum
Session
Symposium
Tutorial
Workshop
Trk 02: Proj-Port Mgt-Strat Planning
All
Forum
Session
Workshop
Trk 02: Proj/Port Mgt/Strat Planning
All
Forum
Trk 03: Innov Part Model-Outsourcing
All
Forum
Session
Symposium
Trk 03: Innov Part Model/Outsourcing
All
Session
Trk 04: Preclin Transl-Early Clin Dev
All
Forum
Session
Symposium
Trk 05: Reg of Prod Adv-Mkting
All
Forum
Session
Trk 05: Reg of Prod Adv/Mkting
All
Forum
Session
Trk 06: Med Comm-Wrtg-MSL
All
Session
Symposium
Trk 06: Med Comm/Wrtg/MSL
All
Session
Trk 07: Tech-Data- Records-Subs
All
Forum
Session
Symposium
Trk 07: Tech/Data/ Records/Subs
All
Forum
Session
Symposium
Trk 08: Reg Affairs
All
Forum
Session
Tutorial
Trk 09: Med Devices-InVitro-CombProd
All
Forum
Session
Trk 09: Med Devices/InVitro/CombProd
All
Session
Trk 10: Pub Pol-HealthCare Compl-Law
All
Forum
Session
Tutorial
Trk 10: Pub Pol/HealthCare Compl/Law
All
Forum
Session
Trk 11: Quality in CT-GCP
All
Forum
Session
Tutorial
Trk 11: Quality in CT/GCP
All
Session
Trk 12: Pharm Quality
All
Forum
Session
Trk 13: CER-Glob Health Econ
All
Forum
Session
Tutorial
Trk 13: CER/Glob Health Econ
All
Forum
Session
Trk 14: Clin Safety-PV
All
Forum
Session
Tutorial
Trk 14: Clin Safety/PV
All
Session
Trk 15: Statistics
All
Forum
Session
Tutorial
Trk 16: Prof Development
All
Forum
Session
Tutorial
Workshop
Trk 17: Rare-Orphan Diseases
All
Forum
Session
Symposium
Tutorial
Trk 17: Rare/Orphan Diseases
All
Session
Trk 18: Global Regulatory
All
Forum
Session
Trk 19: DIAmond
All
Forum
Trk 20: Innov Theater
All
Session
Trk 21: Poster Presentations
All
Poster Presentation
Trk 22: Engage and Exchange
All
Workshop
Trk 23: Opening Plenary
All
Session
Credit Type
ACPE
CME
IACET
PMI
RN
Audience
Advanced
Basic
Intermediate
Featured Topics
21st Century Cures
Agency Participation
Approval Pathways
Audits and Inspections
Benefit-Risk
Big Data
Biologics-Biosimilars
Clinical Trial Designs
Clinical Trial Transparency-Clinical Trial Disclos
Cloud Computing
Community-led-Scientific Working Group Offerings
Current Issues in Policy and Law
Design Thinking
Disease Specific
Disruptive Technologies
Electronic Health Records (EHR)
Emerging Markets
GDUFA-Generics
Hot Topics in Policy and Law
IDMP
Increasing Research and Development Innovation
Interactive Workshop
Labeling
Mobile-Wearable Technology
Observational Studies
Partnership Strategies
Patient Engagement
Patient Recruitment and Retention
Patient Registries
Pediatrics
Precision-Personalized Medicine-Targeted Therapy
Pricing- Reimbursement and Access
Program Offerings for Student Attendees
R&D Innovation
Regulatory Harmonization-Convergence
Risk Evaluation and Mitigation Strategies (REMS)
Risk-Based Monitoring
Social Media Strategies
Topics Related to Asia-Pacific Region
Topics Related to Canada
Topics Related to China
Topics Related to Europe-EMEA
Topics Related to India
Topics Related to Japan
Vaccines
Value-Based Evidence
Women's Health
Interest Area
Academic Health Centers-Investigative Sites
Advertising & Promotion
Biotechnology
Clinical Data Management
Clinical Data Management - eClinical
Clinical Research
Clinical Safety & Pharmacovigilance
Clinical Supplies
CMC
CMC-GMP
Combination Products
Comparative Effectiveness
Document & Records Management
eClinical
Finance
Good Clinical Practices & QA
Information Technology
Manufacturing
Marketing & Sales
Medical Communications
Medical Devices & Diagnostics
Medical Science Liaison
Medical Writing
Non-clinical Safety
Outsourcing
Patient Engagement
Pharmaceutics
Pricing - Reimbursement
Professional Education - Training & Development
Project Management
Public Policy - Health Care Compliance - Law
Public Policy - Law
QA-QC
Quality Assurance - Quality Control
R&D - Strategic Issues
Rare - Orphan Diseases
Regulatory Affairs
Statistics
Strategic Planning
Study Endpoints
Submissions
Val - Electronic Info Integrity
Popular
Filter sessions
Apply filters to sessions.
Filtered by
Interest Area
(Regulatory Affairs) -
Clear filter
close
Dates
Saturday
, June 25
Sunday
, June 26
Monday
, June 27
Tuesday
, June 28
Wednesday
, June 29
Thursday
, June 30
Venue
102AB
103A
103ABC
103C
104A
104AB
105AB
107AB
108A
108B
109AB
111AB
112AB
113A
113B
113C
114
201A
201B
201C
202AB
203AB
204A
204B
204C
Ballroom A
Ballroom AB
Exhibit Hall
Exhibit Hall A
Exhibit Hall B
Liberty Ballroom A
TBA
TBD
Session Type
Preconference Tutorial
All
Tutorial
Trk 01: Clinical Operations
All
Forum
Session
Symposium
Tutorial
Workshop
Trk 02: Proj-Port Mgt-Strat Planning
All
Forum
Session
Workshop
Trk 02: Proj/Port Mgt/Strat Planning
All
Forum
Trk 03: Innov Part Model-Outsourcing
All
Forum
Session
Symposium
Trk 03: Innov Part Model/Outsourcing
All
Session
Trk 04: Preclin Transl-Early Clin Dev
All
Forum
Session
Symposium
Trk 05: Reg of Prod Adv-Mkting
All
Forum
Session
Trk 05: Reg of Prod Adv/Mkting
All
Forum
Session
Trk 06: Med Comm-Wrtg-MSL
All
Session
Symposium
Trk 06: Med Comm/Wrtg/MSL
All
Session
Trk 07: Tech-Data- Records-Subs
All
Forum
Session
Symposium
Trk 07: Tech/Data/ Records/Subs
All
Forum
Session
Symposium
Trk 08: Reg Affairs
All
Forum
Session
Tutorial
Trk 09: Med Devices-InVitro-CombProd
All
Forum
Session
Trk 09: Med Devices/InVitro/CombProd
All
Session
Trk 10: Pub Pol-HealthCare Compl-Law
All
Forum
Session
Tutorial
Trk 10: Pub Pol/HealthCare Compl/Law
All
Forum
Session
Trk 11: Quality in CT-GCP
All
Forum
Session
Tutorial
Trk 11: Quality in CT/GCP
All
Session
Trk 12: Pharm Quality
All
Forum
Session
Trk 13: CER-Glob Health Econ
All
Forum
Session
Tutorial
Trk 13: CER/Glob Health Econ
All
Forum
Session
Trk 14: Clin Safety-PV
All
Forum
Session
Tutorial
Trk 14: Clin Safety/PV
All
Session
Trk 15: Statistics
All
Forum
Session
Tutorial
Trk 16: Prof Development
All
Forum
Session
Tutorial
Workshop
Trk 17: Rare-Orphan Diseases
All
Forum
Session
Symposium
Tutorial
Trk 17: Rare/Orphan Diseases
All
Session
Trk 18: Global Regulatory
All
Forum
Session
Trk 19: DIAmond
All
Forum
Trk 20: Innov Theater
All
Session
Trk 21: Poster Presentations
All
Poster Presentation
Trk 22: Engage and Exchange
All
Workshop
Trk 23: Opening Plenary
All
Session
Other Filters
Credit Type
ACPE
CME
IACET
PMI
RN
Audience
Advanced
Basic
Intermediate
Featured Topics
21st Century Cures
Agency Participation
Approval Pathways
Audits and Inspections
Benefit-Risk
Big Data
Biologics-Biosimilars
Clinical Trial Designs
Clinical Trial Transparency-Clinical Trial Disclos
Cloud Computing
Community-led-Scientific Working Group Offerings
Current Issues in Policy and Law
Design Thinking
Disease Specific
Disruptive Technologies
Electronic Health Records (EHR)
Emerging Markets
GDUFA-Generics
Hot Topics in Policy and Law
IDMP
Increasing Research and Development Innovation
Interactive Workshop
Labeling
Mobile-Wearable Technology
Observational Studies
Partnership Strategies
Patient Engagement
Patient Recruitment and Retention
Patient Registries
Pediatrics
Precision-Personalized Medicine-Targeted Therapy
Pricing- Reimbursement and Access
Program Offerings for Student Attendees
R&D Innovation
Regulatory Harmonization-Convergence
Risk Evaluation and Mitigation Strategies (REMS)
Risk-Based Monitoring
Social Media Strategies
Topics Related to Asia-Pacific Region
Topics Related to Canada
Topics Related to China
Topics Related to Europe-EMEA
Topics Related to India
Topics Related to Japan
Vaccines
Value-Based Evidence
Women's Health
Interest Area
Academic Health Centers-Investigative Sites
Advertising & Promotion
Biotechnology
Clinical Data Management
Clinical Data Management - eClinical
Clinical Research
Clinical Safety & Pharmacovigilance
Clinical Supplies
CMC
CMC-GMP
Combination Products
Comparative Effectiveness
Document & Records Management
eClinical
Finance
Good Clinical Practices & QA
Information Technology
Manufacturing
Marketing & Sales
Medical Communications
Medical Devices & Diagnostics
Medical Science Liaison
Medical Writing
Non-clinical Safety
Outsourcing
Patient Engagement
Pharmaceutics
Pricing - Reimbursement
Professional Education - Training & Development
Project Management
Public Policy - Health Care Compliance - Law
Public Policy - Law
QA-QC
Quality Assurance - Quality Control
R&D - Strategic Issues
Rare - Orphan Diseases
Regulatory Affairs
Statistics
Strategic Planning
Study Endpoints
Submissions
Val - Electronic Info Integrity
Popular