![]() For products that have received marketing authorisation, PADERs (Periodic Adverse Drug Experience Report) or Periodic Safety Update Reports (PSURs) are required, also referred to as Periodic Benefit Risk Evaluation Reports (PBRERs). For products in clinical trials, FDA requires submission of Investigational New Drug (IND) reports, whereas EMA requests annual Developmental Safety Update Reports (DSURs) and other regions may require Annual Safety Reports (ASRs). To verify that MAHs live up to these obligations, Competent Authorities require the submission of periodic safety reports wherein an overview of the safety findings is presented. The major goal of pharmacovigilance is to ensure continuous monitoring of the safety profile of medicinal products.
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