The Identification of Medicinal Product (IDMP) initiative has the potential to significantly impact various aspects of data submissions from manufacturing data to structured substance information and registration information.
To prepare for IDMP, life sciences teams must conduct an IDMP Readiness Assessment to understand their current state, identify gaps, and select the right implementation strategy. Although IDMP is being driven as an upcoming submission requirement to the European Medicines Agency (EMA); technical solutions should remain flexible for global data standards and maximize the benefits of structured product data.
IDMP Readiness Assessment
The assessment requires a broad look at current data infrastructure and supporting business processes. It should reflect and define the organizations vision for compliance with data standards from individual health authorities that may have different IDMP implementation schedules.
It is also important to consider various business preparation and implementation strategies. This analysis should prioritize a data quality assessment so the company can implement desired data models and rely on the data to inform future decisions.
Addressing data quality issues prior to IDMP implementation will accelerate the project and decrease the risk of failure. Automated tools can facilitate intelligent data mapping and reporting that is traditionally labor-intensive and prone to error. Output from this exercise will inform the organization’s IDMP implementation strategy.
IDMP will impact multiple departments, systems, processes, and existing data standards. A well-thought-out approach is required to address the complexity and scale of the project and to reduce risk of compliance.
NNIT Solutions
NNIT uses a proven methodology to help clients understand the implications of IDMP and develop the best strategy to meet their organization’s needs.
Our advisory services are founded in deep regulatory knowledge and formidable technical expertise. We leverage this foundation to develop and implement successful IDMP strategies for our clients.
We also use our robust data quality solutions to help life sciences organizations understand the IDMP data requirements and the underlying data processes that support them. Once we can ensure the quality of the data being used, and our customer has high confidence in the data, we can recommend potential tools and strategies to accelerate the implementation.
Reach out if you wish to learn more about NNIT’s Life Sciences Advisory Services and how we can help you prepare your organization for IDMP.
