In light of recent changes in the European Pharmacovigilance Legislation (Good Pharmacovigilance Practice – GVP) the clinical CRO ICRC-Weyer is extending their Medical Writing service with specialized Pharmacovigilance Writing. With this enhanced service offering the company intends to meet the increasing demand for current, regulatory-compliant drug safety reports.
‘Pharmacovigilance Writing has evolved to be a discipline of its own. It includes the compilation, preparation, maintenance and document management of aggregate safety reports for all stages in the drug development process’ says Dr Ulrike Treichel, Head of Pharmacovigilance at ICRC-Weyer. ‘Thus, the role of the Medical Writer in Pharmacovigilance becomes more important. This has previously rather been regarded as a drug safety task. With the new European GVP legislation both processes and documents become streamlined, which creates a need for professionally compiled and harmonized content.’
The documents in question include the Developmental Safety Update Report (DSUR) which replaces the previously used Annual Safety Report (ASR), furthermore the Periodic Safety Update Report (PSUR) as well as the Risk Management Plan (RMP). According to Ulrike Treichel, the central focus of these reports has also shifted towards benefit-risk assessment rather than merely safety aspects. Other challenges are lay audience summaries and extended materials for risk minimization which can only be done by professional communicators. Hence, the documents require a special combination of capabilities.
Britta Eichhorn, Senior Medical & Pharmacovigilance Writer at ICRC-Weyer, says: ‘Compliance with authority-issued templates and guidelines is pivotal in this process. In order to ensure this, our experienced Medical Writers have been specifically trained on current legislation and the peculiarities of PV documents. This gives us the ability to manage the documents while, at the same time, integrating information from cross-functional teams. As a result, the content is harmonized without altering key safety statements, assuring consistency and safety-related messaging alignment within and across documents.’
Although Pharmacovigilance Writing can be regarded as a relatively new discipline, ICRC-Weyer’s medical writers have already worked on the compilation and management of several of such documents in the past. Their consistent updating of mainly DSURs and RMPs over the past years has laid the groundwork for the application of new templates and guidelines which have now become a regulatory requirement. ‘Our competitive advantage compared to other CROs is that we have already been successfully working with these templates and guidelines, especially the Risk Management Plan’ Ms Eichhorn continues. ‘With this and with the creation of lay audience summaries within the Risk Management Plan – another novelty of the new GVP legislation – we have taken over a pioneering role in the market.’
The specific characteristics of the Pharmacovigilance Writing service is the close cooperation between the Medical Writing and Pharmacovigilance departments. A dedicated PV Manager performs a thorough review and quality control ensuring a guaranteed high-quality and PV-related compliance. The Pharmacovigilance Writing service was adopted by ICRC-Weyer as a symbiotic approach. The specially trained writers can draw on a pool of expertise in the area of Pharmacovigilance and their already excellent communication capabilities as Medical Writers.