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Aggregate Reporting and Safety Writing
Aggregate reports by safety writing experts
Aggregate reporting regulations have recently undergone a revision across the European Union. It is only a matter of time before the revisions are accepted and mandated globally to further strengthen the signal detection system and optimize the use of resources across the pharmacovigilance network for the benefit of public health.
Aggregate Reporting - Regulatory Requirements
We help you to meet regulatory requirements for aggregate reporting with the help of our closely aligned scientific writing and pharmacovigilance teams, to support aggregate reporting and safety writing for all stages of the product life cycle, including summary of product characteristics, Reference safety information, Safety Update Report, Periodic Benefit-Risk Evaluation Reports among others. We have also helped customers by having our aggregate reporting team harmonize with their case processing partner to provide quality aggregate reports.
汇总报告 - 支持
我们在维护您的全球报告日历中，提供完全支持总报告 - 克赖特SPC，ASR，RSI，PSUR，Pader和Pbers-从所有相关部门，编写安全报告和医学审查的信息，提交定期文件到监管机构。我们的总报告组包括医疗保健专业人士和医生，他们在治疗领域训练有素，广泛地经历，以了解全球监管要求。
Our customers repeatedly look upon us as a partner to support them on all their ad-hoc regulatory requirements such as performing an unscheduled benefit-risk assessment in response to a potential risk, to the authoring of Risk Management Plans for new license application and renewal purposes.