Standardized Corporate Projects
Four classes of Corporate Projects are supported for each Active Substance in the eCTD Integral Information System.
The four classes of Corporate Projects are:
- Pre-Clinical Tests Projects
- Clinical Trial Projects
- Medicinal Product(s) Regulatory Projects
- Medicinal Product(s) Marketing Projects
For each class of Corporate Projects following types of standardized projects and sub-projects are defined:
Pre-Clinical Tests Projects
Clinical Trial Projects and sub-Projects
- Interventional Clinical Trials Projects
- Clinical Trial Authorization Project
- Monitoring Audit sub-projects
- Paediatrics sub-project
- Orphan sub-project
- Clinical Trial Realization Project
- Clinical Trial Variation - NCA and EC(s) Projects
- Clinical Trial Variation - EC(s) Projects
- Clinical Trial Variation - NCA Projects
- Clinical Trial Authorization Project
- Observational Clinical Trial
Medicinal Product(s) Corporate Projects
- Medicinal Product Authorization Projects
- Medicinal Product National (CC) Marketing Authorization Project
- Medicinal Product EU Mutual Recognition Marketing Authorization Project
- Medicinal Product EU Decentralized Marketing Authorization Project
- Medicinal Product EU Centralized Marketing Authorization Project
- Medicinal Product Extension Authorization Project
- Medicinal Product EU Repeat Use Authorization Project
- Medicinal Product Realization Projects
- Medicinal Product Realization Project
- Medicinal Product Variation - IA Projects
- Medicinal Product Variation - IA national Project
- Medicinal Product Variation - IA mutual recognition Project
- Medicinal Product Variation - IA centralized Project
- Medicinal Product Variation - IB Projects
- Medicinal Product Variation - IB national Project
- Medicinal Product Variation - IB mutual recognition Project
- Medicinal Product Variation - IB centralized Project
- Medicinal Product Variation - II Project
Medicinal Product(s) Marketing Projects
- Marketing of Medicinal Product Authorization Project
- Marketing of Medicinal Product Realization Project
The Realization of all Corporate Projects consists of:
- Initial Submission Preparation
- Implementation of the Project and
- Project closure
The Realization of all Corporate Projects consists of:
- Initial Submission Preparation
- Implementation of the Project and
- Project closure
The Realization of Corporate Projects is conducted through a series of interrelated project activities with project milestones, project significant events and intersections leading to project Closing.
A detailed presentation of a typical Realization of a Corporate Project is presented here.