ICRC-Weyer Enhance Pharmacovigilance Risk Management
(08.01.2013, Pharma-Zeitung.de)
The Berlin-based clinical contract research organization ICRC-Weyer has made further enhancements to their Pharmacovigilance risk management. By integrating medical review procedures into the Pharmacovigilance system the company is now able to provide efficient risk management strategies in line with current market and regulatory developments.
The decision to pursue this integration process was made following ICRC-Weyer’s recent participation at the Evolution Summit in Munich, Germany, an industry forum bringing together representatives from the pharmaceutical and biotech industries with innovative solution providers. At the event, Dr Ulrike Treichel, Head of Pharmacovigilance at ICRC-Weyer, presented her findings and experiences in striking a balanced medical review process to build a robust Pharmacovigilance strategy.
‘The talk generated a tremendous amount of interest in the topic and resulted in positive feedback and interesting discussions with delegates’ says Dr Treichel. ‘We were particularly pleased about specific requests that were made by trial sponsors at the event. Our Pharmacovigilance and Medical Review teams are very happy to provide this special service and therefore meet the growing demand of pharmaceutical and biotech companies.’
Most Pharmacovigilance systems suffer either from a complete lack of medical review integration or, at the other extreme, a single all-inclusive process resulting in over-integration. By adapting a balanced medical review process ICRC-Weyer is able to build a robust Pharmacovigilance strategy.
Dr Treichel’s talk featured several aspects of this topic, including the assessment of current risk management approaches to pinpoint drawbacks and improve Pharmacovigilance strategies, the identification of expected benefits, potential difficulties and practical considerations of medical review for effective integration, examining past case studies to uncover unforeseen threats and debunk false risks as well as improving processes and minimising overall risks through the successful execution of integrated medical review.
The presentation can be accessed via ICRC-Weyer’s website.
Über ICRC-Weyer GmbH
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.
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