The European Medicines Agency (EMA) will soon require all Marketing Authorization (MA) holders to submit data about their medicinal products so that member states, MA holders and agencies can define, identify, exchange and trace the use of these medicinal products for human use. This effort is called IDMP - Identification of Medicinal Products.
Incredibly, experience from IDMP projects show that only about 40% of the required data is structured in regulatory systems. A full 60% will be unstructured data, buried in documents and other contents – making it very difficult to identify and extract.
Epista can help you find and govern the data you need – both the data that’s already in your databases, and the unstructured data hiding in the dark recesses of your company.. We’ll thoroughly analyze the data and systems in your organization, and pragmatically implement a solution at the appropriate compliance level. We’ll deliver the strategy and technical skills you need for a successful IDMP implementation.
Ask us about our services:
- Project Management
- Organizational Change Management
- IDMP Preparedness and Data Pilot
- IDMP Compliance Strategy
- Search and Selection of the right system to support the IDMP implementation
Get in touch. We enjoy sharing our knowledge and are happy to discuss advancing regulatory compliance in your company: