By ICRC-WEYER GmbH
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ICRC-Weyer Adds Specialised Pharmacovigilance Writing to its Offering
Berlin-based clinical Contract Research Organisation, ICRC Weyer GmbH has responded to recent changes in the European Pharmacovigilance Legislation (Good Pharmacovigilance Practice – GVP) and enhanced its Medical Writing Services by adding specialised Pharmacovigilance Writing to its offering. By adding this service, ICRC-Weyer will meet the growing 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 ICRC-Weyer’s Head of Pharmacovigilance, Dr Ulrike Treichel ‘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.’
This streamlining has seen the Annual Safety Report (ASR), the Periodic Safety Update Report (PSUR) and the Risk Management Plan (RMP) replaced with the Developmental Safety Update Report (DSUR). Ulrike Treichel believes that benefit-risk assessment rather than merely safety reports has now become the focus of these reports. Lay audience summaries and extended materials for risk minimization, which can only be done by professional authors, create further challenges and contribute to a need for special combination capabilities.
ICRC-Weyer’s Senior Medical & Pharmacovigilance Writer, Britta Eichhorn, comments: ‘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.’
Despite Pharmacovigilance Writing being considered to be a recent development within the medical writing industry, ICRC-Weyer’s team of medical writers have worked on the compilation and management of several of this type of documents in the past. The efforts made by ICRC-Weyer’s medical writers to consistently update DSURs and RMPs has meant that it’s a simple process for the team to integrate new regulatory templates and guidelines.
‘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.’
ICRC-Weyer is an established all-phase contract research organization (CRO) based in Berlin, Germany. The company was founded in 1993 by Prof. Dr. Geerd Weyer and offers services ranging from pre-clinical through to phase IV clinical trials. ICRC-Weyer provides complete turnkey solutions including data management, monitoring and medical review services for all stages of the clinical development process. ICRC-Weyer has special expertise in Advanced Therapies, Nutrition, CDISC Data Standards and Medical Review.
About Pharmacovigilance Writing
A successful Pharmacovigilance Writing service requires the close collaboration 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.
Tel: +49 30 403937-0
For more information or to discuss specialised Pharmacovigilance Writing please contact ICRC-WEYER directly.