Introduction to Life Science Information Systems

• Introductions
• Why information management is critical and why it is often overlooked
• What it takes to understand information systems (skills and insights)
• Definitions of informatics, systems, documents, data and records
• Categorizing information
• Enterprise systems: the case for standards (taxonomy reference model)
• Culture, change, organizational behavior and why technology projects are challenging

Developing an Information View and Life Cycle Perspective

• Product development activities (generic model) and how information is used
• Overview of the clinical trials life cycle & critical points in the information chain – where are the data, documents and records?
• Overview of regulatory process & document management – where are the data, documents and records?
• An information model
• Policy, procedures and strategy
• The information package (dossier, submission) - what is your real product

Examination of Regulatory / Clinical

• What life science professionals need to know about information & the FDA
• Deciphering and understanding specific predicate rules that impact systems
• Linking regulations to life science domains and systems
• Preparing, conducting and reporting for clinical trials
• Dossier management and review of current electronic submissions standards
• Components required for a successful transition to the eCTD
• Workshop: review specific guidance and list issues for consideration

Intersection 1: Technology

• Developing information systems that can get the job done
• The critical need for standards (e.g. life science taxonomy)
• Collaboration & integration of systems across the product development life cycle
• Alternatives to monolithic systems – what is the “system” (best practices)
• Managing information retrospectively and prospectively
• Maintaining a compliant environment

Intersection 2: Process

Process Mapping Workshop & Practical Experience

• Workshop: Hypothetical case study – map the process for a clinical study report at Mantra Biopharma
• Participant presentations
• Review, feedback & discourse 

Intersection 3: People: Human & Organizational Factors

• Leveraging success: collaborating within an enterprise
• Collaborating outside the enterprise (partnerships & external systems)
• Maintenance, upgrades and measuring the deltas – what do we need to know?
• Training and striving to be a “Learning Organization”
• Case for Training & Today’s Choices: leader-led, e-learning, hybrid
• Workshop: Review TBD based on group needs by instructor

Standards & the Road Ahead

• The prospective view – are you in healthcare?
• What you should expect
• Health care, government & a little bit of economics
• Final review and summary

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