| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 23.02.2014 09:04:18 |
| Modified: | 27.02.2018 10:52:59 |
| Advanced : | |
| Appears In: | 6.5 Risk-benefit analysis, 9. Production and post-production information, CA_Clinical Affairs, Do AE surveillance |
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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
«BusinessProcess» Do clinical study forecast- «BusinessProcess» Manage clinical study
- «BusinessProcess» Perform clinical study based on CIP
- «BusinessProcess» Do AE surveillance
- Do AE surveillance
«Activity» Check for potential impact to DHA- «Activity» Evaluate BfArM AE database
- «BusinessProcess» Evaluate FDA MAUDE database
- «Activity» Generate critical issue related to AE surveillance
- «Activity» Update AE surveillance report
- «Activity» Update DHA
«EndEvent» AE surveillance done
«IntermediateEvent» Involve RM representative
«StartEvent» Update AE surveillance
«Gateway» Critical impact on DHA found?- «Gateway» New, applicable AEs found?
- «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