SOURCE: Xtalks

Xtalks Webinars

September 30, 2016 07:00 ET

Will Your CMC Data be IDMP e-Submission Ready by 2018? New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - September 30, 2016) - During the webinar, Maroun Elias, Business Analyst and Structured Substance Information (SSI) SME at NNIT USA will outline 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). The live event will take place on Wednesday, October 19, 2016 at 1pm EDT.

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). The substance information in scope of IDMP encompasses the entire medicinal product formulation in order to standardize how active pharmaceutical ingredients (APIs) and excipients are identified globally for the purpose of improving the accuracy of patient safety reporting of adverse events.

Many companies however, do not have one dedicated robust repository for substance data. The majority of IDMP substance information is located in CMC documents such as the quality modules 3.S and 3.P in the CTD or scattered among silo systems at CMOs and excipient suppliers.

Compliance with ISO 11238 will require life sciences companies to give an even greater emphasis to the substance data governance-who owns it, how it gets managed, how it gets validated, and strategies that integrate structured information from early drug discovery and throughout the entire life cycle of medicinal product.

Key Takeaways

  • 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

To learn more about this event visit: Will Your CMC Data be IDMP e-Submission Ready by 2018?

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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