On August 4, 2016, The European Medicines Agency (EMA) hosted a webinar for the industry to further the understanding of the substance, product, organization and referential (SPOR) data services and related impacts. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. This approach will allow lessons learned during each phase to be applied to subsequent phases, processes and systems to mature over time and stakeholders to gain an understanding prior to the full roll out.
Implementation will be structured in three main phases: preparation, transition and maintenance.
The first part of the webinar focused on explaining the ISO IDMP standards to emphasize their importance to industry. Each SPOR area was explained, discussed and presented by a dedicated EMA subject matter expert underlining their role in IDMP’s quest of standardization to improve communication, faster mapping and identification of medicinal products.
The second part of the webinar then provided an update on the current implementation efforts of the SPOR project including discussing data collection sub-projects and system implementation status.
The broader topics of electronic data security and data protection were discussed with particular emphasis on the significance of these concerns in Europe. Understandably, the SPOR implementation team faces these challenges just as vendors and industry do as well. This becomes even more important as the data currently collected and stored by the EMA may be partially confidential, making the data protection and data security topics for SPOR a very active area of discussion and development.
As expected, great importance is attached to the compliance with legal requirements for data protection, privacy, confidentiality and data access policies including data classification and standards for security and privacy. The publication processes for interactive user requirements and system interfaces for data queries was also explained
As mentioned above, the timing and milestones alongside the engagement approach and plan were the major focus of the webinar.
If you missed the webinar, the recording can be found following these links:
Video of the broadcast:
Presentation deck (documents tab):