Article discuses progress in implementing web-based Human variations electronic Application Forms (eAFs) with a focus on enhancing data quality and system performance.
We would like to present an update on the progress of the web-based Human variations electronic Application Forms (eAFs) implementation on Product Lifecycle Management (PLM) Portal.
The primary goal remains to create web-based versions of interactive PDF forms eAFs to make it easier for both applicants and regulators to input and manage information related to variations, marketing authorizations, and renewal applications.
Primary focus at the moment is ensuring the quality of data and the performance of the system while preparing a transition-ready version of the web-based Human variations eAF.
In the first quarter of 2024, there are plans in place for the following activities:
- Introduction of Centrally Authorised Products (CAPs), which have been split from the original data structure in SIAMED to comply with ISO IDMP standards. These split CAPs required an additional data migration process in addition to the initial matching and merging protocol before they could be used in the variations eAF.
- Release National Authorised Products (NAPs) for use in the Human variations eAF;
- Introduction of User Interface (UI) for Product Data Management that will make it easy for users to access and view their product data stored in the Product Management Services (PMS) database.
- Releasing all products (NAPs and CAPs) from the PMS to the PLM portal in the production environment.
More comprehensive update will be available at the end of Q4 2023 where quality, system and available data will be presented.
Anyone who is interested in the development of eAF and PMS can watch the specific parts of the Q3 System Demo recording, which can be found on the EMA’s website.