REKS 3rd QUARTER 2021 NEWSLETTER
On August 25th, a seminar for end users and marketing authorisation holders took take place in Tallinn, where an overview of the last year’s period after the end of the transition period was be given. Video guides for end users were prepared by Hansasoft. The implementation of FMD from the perspective of pharmaceutical manufacturers was also covered. The seminar is also on demand (Event ID: REKS2021).
The video instructions for Hansasoft software introduced at the seminar can be found on REKS’ website.
Occasionally REKS recieves inquiries that raise concerns about end-user information system error messages. Unfortunately, it is not possible for REKS to help, however Hansasoft has come to the aid of its customers and complied informative video instructions.
Another yearbook of REKS has been completed, which can be found at https://yb2020.reks.ee.
Last year’s keywords are REK-IS, i.e. the creation of an alert management system, the end of transitional period in Estonia, the beginning of the creation of AMS or alert management system by EMVO, but certainly also COVID vaccines. Physical training was replaced by virtual training which was certainly a new experience for both REKS and listeners on this scale. The financial model changed, new contracts were concluded with MAHs and the annual fees decreased
The ratio of alerts to scans in Estonia fell to 0.01% in September (at the beginning of the year, this figure was 0.16%).
At EU level, alerts are mostly associated with an unknown batch number and least associated with an expiry date (Figure 2).
In the fourth quarter of the year, REKS is awaiting an annual security audit. In terms of access to the list of exceptions on REKS’ website, entering a username and password will become required in the future. The relevant information is sent to all end users by e-mail. The reason for the change is greater data security.
REKS team wishes everyone a beautiful autumn!