Each CSR is a distinctive and complex document composed to support the efficacy and safety claims showcased throughout the approval dossier. While health authorities and guidelines state that CSR should remain a responsible length to showcase all vital data, the overarching aim for CSRs is to portray trial data to reviewers succinctly, accurately and clearly. It is vital for content authors to have a comprehensive understanding of the guidelines that form the structure for the generation of CSRs, as creating thorough and compliant CSRs will idyllically decrease regulatory review times and push innovative treatments to the market faster.
This pharmaceutical regulatory writing webinar series will be divided into two courses with the first portion focusing on CSR document development and the second on CSR narrative composition and appendices. Participants will gain a better understanding of CSR strategy and execution through the practical experiences and insight of a seasoned regulatory writer. Common themes to be discussed in both courses include current standards and guidelines outlined by ICH E3, project planning, writing and review processes, strategic meetings, project and vendor management.
Principal Medical Writer