Safety Reports: The importance of high quality content from regulatory perspective

The action plan developed by the AEMPS and published April 2016 focuses on the set up of specific activities, such as the publication of Risk Management Plans Summaries by the agency or the need to increase the number of inspections included in the Good Pharmacovigilance Practice programmes for human and veterinary use. Essentially, this infers…

Periodic Benefit-Risk Evaluation Report (PBRER)

According to European Medicaments Agency (EMA) guidelines, already implemented since 2012; Marketing Authorization Holders (MAHs) have to submit periodic updated safety reports following GVP Module VII. The objective of this submission is to harmonise all the existing information relating to every single medicinal product; in order to update their risk-benefit profile. This strategy allows EMA…