-
Updated version of the Danish Medicines Agency's guidance on risk-adapted recording and reporting of adverse events in clinical trials is now available on the website
| 23 October 2024 |
The Danish Medicines Agency’s guidance on risk-based recording and reporting of adverse events in clinical trials on medicinal products under Regulation (EU) no. 536/2014 has been updated and version 2.0 is now available on the website, in both Danish and English. The guidance has been updated with further clarification on the requirements, if risk-adapted adverse event management is implemented. For an overview of the changes, please refer to the change log in the guidance document.
-
Nils Falk Bjerregaard new Director General of the Danish Medicines Agency
| 03 October 2024 |
The Danish Ministry of the Interior and Health has appointed Medical Director Nils Falk Bjerregaard as Director General of the Danish Medicines Agency as of 1 November 2024.
