About this document
PBRER Guidelines from Swissmedic by MohabKamal is a document available to read on EtoBox.
The document discusses recommendations from Swissmedic on the new EU Pharmacovigilance Modules and periodic safety update reports (PSURs)/periodic benefit-risk evaluation reports (PBRERs) for Switzerland. It addresses questions from the pharmaceutical industry regarding implementation of the new regulations. Swissmedic confirms that timelines for submission remain unchanged and that one-year PBRERs are preferred over two six-month reports. Swissmedic requests include following EU PBRER format and guidelines
- Author
- MohabKamal
- Language
- EN