Providing an Entire Safety Department The Background A manufacturer of biosimilar medicines partnered with a large global pharmaceutical company to conduct the pivotal clinical trial with the aim of applying for global marketing licences for a new oncology biosimilar...
9th Global Pharmacovigilance & RWE Forum On the 30th and 31st of May 2024, the 9th Global Pharmacovigilance & RWE Forum was held in the Hilton London Kensington. This conference was part of the Pharmacovigilance World Tour by Why Summits conference organisers....
Regulating AI in Pharmacovigilance Everyone is talking about AI: What is it? Will it take our jobs? Will it save the world or will it ruin everything? So when I was lucky enough to be invited to a panel discussion called “Regulating AI in Pharmacovigilance” I jumped...
CSR Safety Narratives - Part 2 of 2 (Saving your time and money) If you missed the last instalment of this series, click here to read Part 1 – Saving your time and money. Challenges with creating CSR Narratives Narrative categories A narrative needs to be...
CSR Safety Narratives - Part 1 of 2 (Saving your time and money) Regulatory Guidance: Within a year of completing a clinical trial the Sponsor needs to provide a completed study report (CSR) to the regulatory agencies who approved the trial. According to ICH E3...
