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DIA 2016 Annual Meeting
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Preconference Tutorial
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Trk 01: Clinical Operations
All
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Workshop
Trk 02: Proj-Port Mgt-Strat Planning
All
Forum
Session
Workshop
Trk 02: Proj/Port Mgt/Strat Planning
All
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Trk 03: Innov Part Model-Outsourcing
All
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Symposium
Trk 03: Innov Part Model/Outsourcing
All
Session
Trk 04: Preclin Transl-Early Clin Dev
All
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Session
Symposium
Trk 05: Reg of Prod Adv-Mkting
All
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Session
Trk 05: Reg of Prod Adv/Mkting
All
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Trk 06: Med Comm-Wrtg-MSL
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Trk 06: Med Comm/Wrtg/MSL
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Trk 07: Tech-Data- Records-Subs
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Trk 07: Tech/Data/ Records/Subs
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Session
Symposium
Trk 08: Reg Affairs
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Session
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Trk 09: Med Devices-InVitro-CombProd
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Trk 09: Med Devices/InVitro/CombProd
All
Session
Trk 10: Pub Pol-HealthCare Compl-Law
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Session
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Trk 10: Pub Pol/HealthCare Compl/Law
All
Forum
Session
Trk 11: Quality in CT-GCP
All
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Trk 11: Quality in CT/GCP
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Trk 12: Pharm Quality
All
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Trk 13: CER-Glob Health Econ
All
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Session
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Trk 13: CER/Glob Health Econ
All
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Session
Trk 14: Clin Safety-PV
All
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Session
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Trk 14: Clin Safety/PV
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Trk 15: Statistics
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Trk 16: Prof Development
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Trk 17: Rare-Orphan Diseases
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Trk 17: Rare/Orphan Diseases
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Trk 18: Global Regulatory
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Trk 19: DIAmond
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Trk 20: Innov Theater
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Trk 22: Engage and Exchange
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ACPE
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IACET
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RN
Audience
Advanced
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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
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Clinical Data Management
Clinical Data Management - eClinical
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Clinical Safety & Pharmacovigilance
Clinical Supplies
CMC
CMC-GMP
Combination Products
Comparative Effectiveness
Document & Records Management
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Finance
Good Clinical Practices & QA
Information Technology
Manufacturing
Marketing & Sales
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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
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Regulatory Affairs
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Study Endpoints
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Val - Electronic Info Integrity
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Wednesday
, June 29
8:00am EDT
#301: The Future of Big Data
103ABC
#302: Europe and the US: Making Outcomes-Based Health Care Possible
114
#303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
Ballroom A
10:30am EDT
#320: Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials
201A
#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
#318: Changes to Common Rule Likely Affecting FDA-Governed Research
202AB
#322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence
107AB
#327: FDA–Health Canada Regulatory Cooperation Council Town Hall
201C
#307: Mythbusting Site Productivity: Referral Practices and Untapped Site Options
108A
#308: Patient Recruitment Workshop: Survey Results and Practical Application
102AB
#310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch
108B
#309: Global Stakeholder Management: Across the Ocean Between East and West
105AB
#311: Outsourcing: Assessing CRO Performance and Challenges
111AB
#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
#319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development
204A
#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
#325: Reinventing You: How to Change Your Career Fearlessly!
112AB
#326: FDA Rare Disease Town Hall
103A
2:00pm EDT
#341: eTMF: Selection, Implementation, and What's Next?
204B
#351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies
108B
#353: The Utility of Natural History Studies in Drug Development and Approval
103C
#333: Hearing the Patient Voice in Pharma and What Patients Want You to Know
113A
#334: Risky Business: Latest Trends, Strategies, and Tools for Predicting Success and Monitoring Risk During Clinical Trial Operations
113B
#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
#337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools
112AB
#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
#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
#344: Companion Diagnostics: Driving New Business Models for Successful Outcomes
103A
#345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority?
202AB
#346: Anticipating and Responding to Challenges in Issue Management
204A
#347: Global Harmonization: Non-ICH Regions
111AB
#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
#352: From Mistakes to Success: Lessons Learned from Organizational Change Management Programs
102AB
#350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort?
108A
4:00pm EDT
#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results
105AB
#361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep
203AB
#367: Quality at the Edge(s): Design It Right and Keep It Going in Non-Interventional Studies
204A
#368: Conducting Trials in China
201A
#372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes
113C
#371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety
113A
#374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations
108A
#375: Creating Competent Clinical Research Professionals Through Systematic Evidence Review
112AB
#357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects
108B
#358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages
102AB
#359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk
111AB
#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
#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
#373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs
113B
#376: Pediatric Rare Disease Drug Development
103C
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DIA 2016 Annual Meeting
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DIA 2016 Annual Meeting
Jun 25
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114
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Trk 11: Quality in CT-GCP
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Trk 13: CER-Glob Health Econ
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Trk 15: Statistics
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Trk 19: DIAmond
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Trk 20: Innov Theater
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Trk 22: Engage and Exchange
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Trk 23: Opening Plenary
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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
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Finance
Good Clinical Practices & QA
Information Technology
Manufacturing
Marketing & Sales
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Medical Devices & Diagnostics
Medical Science Liaison
Medical Writing
Non-clinical Safety
Outsourcing
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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
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Dates
Saturday
, June 25
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, June 26
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, 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
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201C
202AB
203AB
204A
204B
204C
Ballroom A
Ballroom AB
Exhibit Hall
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Liberty Ballroom A
TBA
TBD
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Preconference Tutorial
All
Tutorial
Trk 01: Clinical Operations
All
Forum
Session
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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
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Symposium
Trk 03: Innov Part Model/Outsourcing
All
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Trk 04: Preclin Transl-Early Clin Dev
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Trk 05: Reg of Prod Adv-Mkting
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Trk 05: Reg of Prod Adv/Mkting
All
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Trk 06: Med Comm-Wrtg-MSL
All
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Trk 06: Med Comm/Wrtg/MSL
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Trk 07: Tech-Data- Records-Subs
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Trk 09: Med Devices-InVitro-CombProd
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Trk 10: Pub Pol-HealthCare Compl-Law
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Trk 10: Pub Pol/HealthCare Compl/Law
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Trk 11: Quality in CT-GCP
All
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Trk 11: Quality in CT/GCP
All
Session
Trk 12: Pharm Quality
All
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Trk 13: CER-Glob Health Econ
All
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Session
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Trk 13: CER/Glob Health Econ
All
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Trk 14: Clin Safety-PV
All
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Trk 14: Clin Safety/PV
All
Session
Trk 15: Statistics
All
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Trk 16: Prof Development
All
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Trk 17: Rare-Orphan Diseases
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Trk 18: Global Regulatory
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Trk 19: DIAmond
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Trk 20: Innov Theater
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Trk 22: Engage and Exchange
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Trk 23: Opening Plenary
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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