| Click on the session title for a complete description. |
| Day |
Session Link |
| Monday |
CDASH/Standards and the Practical Implications |
| Monday |
Getting that Fresh, Clean Feeling: Defining “Clean” Data |
| Monday |
Metrics and The Benefits of Them |
| Monday |
A La Carte or Prix Fixe: The Right Menu for Clinical Trials Technology |
| Monday |
FDA's Drug e-Reg and Listing System: One Year Later |
| Monday |
Global Submission Management: Challenges and Opportunities |
| Monday |
Overcoming Regulatory Diversity to Gain Market Approval in Latin American Regions |
| Monday |
Extreme Programming in the Life Sciences |
| Monday |
Smashing Silos: Bringing Service-oriented Architecture and Data Warehousing to a Pharmaceutical Company Environment |
| Monday |
Utilizing and Integrating Open Source Software in Clinical Research Environments |
| Tuesday |
From Case Report Form to CDISC SDTM: Data Standards |
| Tuesday |
Future of Data Management/Evolving Role of Data Management |
| Tuesday |
Metric-based Management and eClinical Trials |
| Tuesday |
Site Preferences for EDC: A Comparison of European and North American Perspectives |
| Tuesday |
Accelerating Site Initiation through a Shared Collaborative Platform |
| Tuesday |
Monitoring of Patient Compliance with eTechnologies |
| Tuesday |
Standards in Your Future: How SAFE-BioPharma, IHE and CDISC Are Collaborating to Improve Safety Reporting |
| Tuesday |
Structured Product Labeling (SPL) Indexing at FDA: Where We Are Today and Towards the Future |
| Tuesday |
Annual CDER eSubmission Update: The Review Perspective |
| Tuesday |
Annual CDER eSubmission Update: The Technical Side |
| Tuesday |
FDA Data Standards Initiatives |
| Tuesday |
Implementing Global Electronic Submissions: The Company and the Regulators Give their Points of View |
| Tuesday |
caBIG® Clinical Trials Management System (CTMS): A Standardized, Integrated Approach to Clinical Trials Management - A System Overview, and Implementation Case Study |
| Tuesday |
Clinical Trial Metadata: Theory into Practice |
| Tuesday |
Integrated Web-based Tools Supporting the Pharmaceutical Policies of Regulatory Bodies: From Clinical Trial National Registries to the Regulatory eSubmission |
| Tuesday |
Streamlining Your Clinical Data Environment, End-to-End, Using a Standards-based, Metadata-driven Approach - A Panel Discussion |
| Tuesday |
Computerized Systems Used in Clinical Research: Best Practices from Peach - Part 1 |
| Tuesday |
Computerized Systems Used in Clinical Research: Best Practices from Peach - Part 2 |
| Wednesday |
Mega Trials: Planning, Design, Development, Monitoring and Overall Management |
| Wednesday |
Offshoring/Outsourcing CDM: Will It Last? |
| Wednesday |
Outsourced Data Management: How to Align Performance Expectations |
| Wednesday |
WHO Drug Dictionary Utilization |
| Wednesday |
CDISC Pilots |
| Wednesday |
Leveraging Electronic Health Records in Clinical Research |
| Wednesday |
Update on the FDA's Electronic Case Report Form Submission Operational Data Model (ODM) Pilot |
| Wednesday |
Views of the CDISC Standards in a Submission |
| Wednesday |
International eCTDs: An Update on Regulatory Authority Experience |
| Wednesday |
Creation of Marketing Applications for the ASEAN Region |
| Wednesday |
Revisiting the Dilemma in 2009: Is There a Cure for the Ills of Electronic Document Management in the Contemporary Biopharmaceutical Industry? And If So, What Is the Medicine Looking Ahead in 2009 and Beyond? |
| Wednesday |
The Multilingual Dimension: Best Practices for Addressing Global Content and Global XML |
| Wednesday |
Convergence of Data and Document Standards: Where Does CDISC Meet eCTD? |
| Wednesday |
Life-cycle Management: Where the Real Challenges Are - Module 3, IND and NDA |
| Wednesday |
What's the Meta with this Data? The Shifting Sands of Submission EDMS |
| Wednesday |
CDISC SDTM Data Conversion: Reusability and Repeatability |
| Wednesday |
Clinical Data Flow and Integration: Three Use Cases from an Information Technology Perspective |
| Wednesday |
Clinical Research Repositories as a Collaboration Platform |
| Wednesday |
Empowering the Enterprise with Software as a Service (SaaS) |
| Wednesday |
An International Perspective on the Use of Computerized Systems in GCP |
| Wednesday |
Auditing Risk-based Computer Validation Projects |
| Wednesday |
Compliance in the Age of Automatic Updates and Virtualization |
| Wednesday |
Town Meeting: Validation Experts Respond to Your Questions and Concerns – OQ, IQ, PQ, and Testing Practices |
| Thursday |
MedDRA® Coding and Clinical Data Management |
| Thursday |
Minimizing Data Queries in Clinical Trials |
| Thursday |
How Much Do Electronic Diaries Improve the Quality of Clinical Research? |
| Thursday |
Standards Shock Therapy: Monitoring the State of CDISC and HL7 for Clinical Research and Regulatory Submissions |
| Thursday |
Addressing Document Collaboration Challenges in Drug Development |
| Thursday |
Pursuing Standards to Enhance eCTD Deliverables: Pharmaceutical and Research Manufacturer Association Electronic Regulatory Submissions (PhRMA ERS) Group Annual Update |
| Thursday |
Breaking Boundaries: Making Sense of Your Data through Collaborative Visualization |
| Thursday |
Implementing Health Informatics Solutions in the Life Sciences Industry |
| Thursday |
Unique Validation Challenges in the Clinical Arena |
| Thursday |
Validation Challenges with Modern System Development Tools and Methodologies |
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