The project covers Business and Technical Analysis activities to support the implementation of ISO IDMP (Identification of Medicinal Products) in Europe, as part of the Data Harmonization & Interoperability Program (DHI Program).
- Collect information in scope of IDMP Iteration 1 in Europe, which are not available yet within internal systems (e.g. RIM)
- The information needs to be collected from source documents (e.g. Module 3, SmPCs), in close collaboration with Regulatory Affairs, CMC… departments and under the supervision of the Data Governance Committee
- The collected information needs to be aligned and harmonized as per IDMP requirements in the EU, and loaded into the relevant source systems
- Contribute to the definition of to-be IDMP submission requirements and processes, to support the selection of a submission tool in line with the objectives of the DHI Program
- Contribute to the integration of the selected IDMP submission tool in the company landscape
- Contribute to the implementation of the submission tool, including user acceptance testing, training materials, procedures, running-in, support to end users…