Will Your CMC Data be IDMP e-Submission Ready by 2018?

Starting Q4 2018, EMA will require substance information to be in a structured data format in compliance with ISO 11238 for life sciences companies to continue conducting clinical trials and selling medicinal products in Europe. ISO 11238 is the IDMP standard for structured substance information (SSI). 

In this presentation, the speakers will discuss key findings of a customer use case that involved an SSI impact assessment for a chemical and protein substance according to the latest ISO Implementation Guideline (March 2016).

• Overview of IDMP and the structure substance IDMP data model
• Discuss the challenges of finding SSI data across the organization IT landscape
• Show the IDMP field data volume overlap between SSI and the CMC data (Quality module 3.2S and 3.2P in the CTD)
• How to leverage ISO 11238 compliance with NNIT Substance Registration System if your company does not have a dedicated substance repository in place
• The benefits of having a substance repository such as the NNIT Substance Registration System