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.
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
Louise Petersen, Senior Consultant and ISO IDMP SME, NNIT
Louise Petersen has a MSc in Pharmacy, from Faculty of Pharmaceutical Science, University of Copenhagen. Her special focus areas is Regulatory Affairs, and especially ISO IDMP, where she has profound knowledge. Louise has worked closely with clients with the business and IT impact within all the areas; Authorized, Investigational and Structured Substance Information (SSI). This includes e.g. field by field analysis, future repositories and the activities required to implement these taken into account implementation strategy, scenarios, organizational impact, business processes. Louise can be contacted at email: LUPT@nnit.com.
Jacob Ekstrøm, Advanced Business Consultant, Life Sciences Industry, NNIT
Jacob has a MSc in Pharmacy, from Faculty of Pharmaceutical Science, University of Copenhagen. He has expert knowledge within Drug Regulatory Affairs and special competencies within Regulatory Affairs Processes, Registration Tracking, Regulatory Information Management Systems (RIMS), and integration with Electronic Document Management Systems. Profound experience within the use of Register® RIM system. Works typically in the role as business consultant responsible for gathering requirements and specifying appropriate design concept. Jacob can be contacted at email: JCEK@nnit.com.
Who Should Attend?
Senior level professionals from biopharma companies working within:
- Regulatory IT
- Regulatory Strategy
- Regulatory CMC
- Regulatory affairs
- Quality assurance / control
- Drug development
- Data architecture
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