| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 23.07.2014 09:04:02 |
| Modified: | 27.02.2015 20:25:08 |
| Diagram Elements : |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
- Clinical Marketing
Clinical Marketing- CA_Clinical Affairs
- CA_Clinical Affairs
«BusinessProcess» Appraisal of individual data sets
Appraisal of individual data sets
«Activity» Chain of evidence information base- «Activity» Analyze individual data set
- «Activity» Clinical evaluation file
- «Activity» Consider individual dataset at DHA
- «Activity» Content to be considered
- «Activity» Determine overall efficacy
- «Activity» Determine residual risks related to individual data set
- «Activity» Evaluate risk related to individual data set
- «Activity» Evalute Efficacy and contra-indications
- «Activity» Perform / Reassess risk-benefit analysis
«EndEvent» Clinical evaluation performed
«StartEvent» New Publication- «EndEvent» Publication rejected
«Gateway» Clinical benefits preponderate residual risks?- «Gateway» Content?
- «Gateway» Dataset to be further evaluated?
«BusinessProcess» Do clinical study forecast- «BusinessProcess» Manage clinical study
- «BusinessProcess» Perform clinical study based on CIP
- «BusinessProcess» Do AE surveillance
- «BusinessProcess» Do / update clinical evaluation
- «BusinessProcess» Apply for clinical validation
- «BusinessProcess» Prepare and apply for clinical study
- CAM_Clinical Application Management
- MC_Marketing & Communications
- PM_Product Management
- TW_Technical Writing
- «BusinessProcess» Manage compentencies CM
- «BusinessProcess» Manage tools and equipment CM
- «BusinessProcess» Plan resources and budget CM
- «BusinessProcess» Report CM
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox