To comply with the requirement for pharmaceutical companies to report adverse events in the E2B format to ANVISA, the Organex team has updated SIS. This update enables the extraction of data from reports in XML based on the E2B standard.
ANVISA’s adoption of E2B aligns with Brazil’s inclusion in the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), furthering their initiative.
The tool provides two submission options: either an individual XML file for each report, or a batch XML file that incorporates several previously selected reports.
In addition, customers can employ the use of MedDRA dictionary to classify indications for the employment of suspect products, concomitants, and diseases. This choice was previously only accessible for categorizing adverse events.
The E2B tool is presently participating in a pilot program conducted by Anvisa, in collaboration with Aché laboratory, and is currently in its second testing phase, having gained approval during the first stage.
Read our interview with Mariana Boa Sorte, who is responsible for the Pharmacovigilance department and the development of this project at Aché.
How was Aché selected to participate in the pilot program and what were the internal implications for Aché?
We have received an invitation from Sindusfarma and ANVISA to participate in the project, which has given us great satisfaction and recognition for all our hard work and efforts.
How do you perceive the partnership with Organex through SIS?
Organex has been a tremendous partner who was supportive from the beginning of the project, going above and beyond to meet our expectations.
What tests were carried out in the initial phase and how has SIS performed during the E2B pilot tests?
We conducted several tests with Organex and our IT team, ranging from report extraction to the incorporation of optional fields in the new version. All the tests were successful and enabled us to proceed with our participation in the project.
What are your impressions of the SIS tests during the ANVISA pilot thus far? Additionally, what are the primary advantages of implementing SIS and E2B standardization?
In general, the SIS system successfully met all the expectations for this project, bringing a positive outcome for both Organex and Aché. Moreover, SIS has helped us make progress in a positive direction.
What are the next steps in the pilot tests with ANVISA?
Currently, we are awaiting feedback from ANVISA regarding the second part of the project.
About SIS
A complete notification and adverse event management system, which offers features that improve the quality and productivity of processes in the areas of Pharmacovigilance, Cosmetovigilance and Toxivigilance.
SIS control the entire process of recording, identifying, evaluating, and monitoring adverse events. Consumers, healthcare professionals and regulatory industries can report adverse events related to your products.
For additional information, please click here.
