- Type Learning
- Level Intermediate
- Time Days
- Cost Paid
Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)
Issued by
DIA
This badge holder can explain essential aspects of medical writing of aggregate safety reports (PSURs and PBRERs) in the context of current legal framework in the EU and globally. They can describe the requirements set out in the ICH E2C(R2) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) - Module VII, as well as global acceptability and local variability in the requirements. They can describe the critical aspects of medical writing, including data editing and presentation.
- Type Learning
- Level Intermediate
- Time Days
- Cost Paid
Earning Criteria
-
Attended a 2-day course.