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ACPE
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Advanced
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Featured Topics
21st Century Cures
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Clinical Trial Transparency-Clinical Trial Disclos
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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
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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
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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
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Val - Electronic Info Integrity
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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
#25: Signal Detection: Identifying and Managing Safety Signals
105AB
9:00am EDT
#43: Risk Management and Safety Communication Strategies
113B
#40: Analysis of Safety Data from Clinical Trials
111AB
#42: Clinical Statistics for Nonstatisticians
113A
#41: A Rare Disease Program Case Study: Strategies for Successful Outcomes
112AB
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
#33: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
107AB
Monday
, June 27
8:30am EDT
#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
105AB
#107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost
202AB
#113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements
108B
#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?
203AB
#110: Updates and Pending Issues in the US Biosimilar Environment
201B
#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?
204B
#114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward
204A
#115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product
111AB
#119: Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Clinical Trials
102AB
#121: Rare Disease Clinical Trials: Coping with Unique Challenges
103A
10:45am EDT
#124: Risk-Based Monitoring in Clinical Trials
113C
#125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration
113A
#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development
102AB
#129: Delivering Value Through Medical Information Metrics
203AB
#130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial
201C
#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned
204C
#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!
201B
#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
108B
#134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy?
103A
#138: Risk Communication and Management: The Art of Communicating Risk - Challenges and Best Practices
109AB
#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?
105AB
#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements
108A
Tuesday
, June 28
8:00am EDT
#202: Changing Cultures to Advance Patient Engagement
103ABC
#203: Next Generation Collaborations: Transforming the Industry
Ballroom A
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
#215: Exploring the Use of Virtual Technologies and Virtual Teams Within Medical Affairs Organizations
202AB
#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification
201B
#222: Valuing the Clinical Trial Patient
204A
#224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How
201A
#227: Unique Global Regulatory Considerations and Drug Development Incentives in Rare Disease and Orphan Drug Development
103C
#212: Special Populations in Clinical Pharmacology Studies
113A
#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
#225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems
113B
2:00pm EDT
#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
#243: Patient Involvement Today and Tomorrow: What’s in It for Patients?
204C
#246: Valuing the Signal and the Noise in Health Care Horizon Scanning
103A
#247: Fit for Purpose and Modern Validity Theory in PROs
105AB
#248: Mind the Gaps: The Science of Designing, Implementing, and Evaluating Benefit-Risk Communication for Medicinal Products
113C
#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics
201A
#254: CBER Town Hall: State of the Center and Plans for the Future
203AB
4:00pm EDT
#262: Solving Challenges and Employing Best Practices in Medical Information Contact Centers
201A
#257: Mobile Apps for Clinical Trials: DIY or AMAZON Strategy? When to Build, When to Buy
113A
#260: A Risk-Benefit Approach to Planning Early Clinical Development
113C
#261: Marketing After Amarin and Pacira
107AB
#263: Patient Centricity in Clinical Trials
201B
#264: FDA Update on Data Standards
204B
#265: Enabling Innovative New Endpoint Measurement Using Mobile Technology
203AB
#266: Perspectives on Expanded Access to Investigational New Drugs
108A
#271: The Things Kids Say: Clinical Outcome Assessments in Pediatric Clinical Trials
103A
#272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance?
113B
#273: Improving Adverse Drug Reaction Information in Product Labels
109AB
#274: Statistical Issues in the Evaluation of Biosimilars
108B
#276: Using Input from Patient Communities to Develop PRO Instruments
103C
Wednesday
, June 29
8:00am EDT
#302: Europe and the US: Making Outcomes-Based Health Care Possible
114
10:30am EDT
#314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End
203AB
#322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence
107AB
#308: Patient Recruitment Workshop: Survey Results and Practical Application
102AB
#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
#323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation
113A
#324: Implementing Adaptive Designs Involves Greater Teamwork
109AB
#326: FDA Rare Disease Town Hall
103A
2:00pm EDT
#351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies
108B
#333: Hearing the Patient Voice in Pharma and What Patients Want You to Know
113A
#335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials
113C
#336: Effect of International Reference Pricing on Planning for Global New Product Launches
105AB
#338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection
201A
#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
#343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape
201B
#345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority?
202AB
#348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC
107AB
#349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements
109AB
#350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort?
108A
4:00pm EDT
#361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep
203AB
#371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety
113A
#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
#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?
103A
#366: Infectious Disease Containment and Lessons Learned
202AB
#369: Innovative and Emerging Technologies
109AB
#370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices
107AB
#376: Pediatric Rare Disease Drug Development
103C
Thursday
, June 30
9:00am EDT
#401: EMA/FDA Question Time
114
#402: Protocol Development Is a Team Sport
103ABC
10:45am EDT
#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
111AB
#403: Running Personalized Medicine Trials: Facts and Figures
108B
#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment
113C
#410: The Role of Big Data in Transforming the Detection of Adverse Drug Reactions
113B
#411: Nonclinical Statistics for Chemistry, Manufacturing, and Control: Case Studies and Regulatory Perspective
108A
#412: CDER Town Hall
114
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DIA 2016 Annual Meeting
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DIA 2016 Annual Meeting
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Big Data
Biologics-Biosimilars
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Clinical Trial Transparency-Clinical Trial Disclos
Cloud Computing
Community-led-Scientific Working Group Offerings
Current Issues in Policy and Law
Design Thinking
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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
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Regulatory Harmonization-Convergence
Risk Evaluation and Mitigation Strategies (REMS)
Risk-Based Monitoring
Social Media Strategies
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Vaccines
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Val - Electronic Info Integrity
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Saturday
, June 25
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, June 26
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, June 27
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, June 28
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, June 29
Thursday
, June 30
Venue
102AB
103A
103ABC
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104A
104AB
105AB
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108A
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109AB
111AB
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114
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Trk 01: Clinical Operations
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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