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.
Aggregate Reporting - Support
We provide complete support on aggregate reports -like SPC, ASR, RSI, PSUR, PADER and PBRER- from maintaining your global reporting calendar, to collating information from all your pertinent departments, authoring safety reports and medical review of the prepared reports, to submitting the finalized document to the regulator. Our aggregate reporting team comprises healthcare professionals and physicians who are well trained and extensively experienced across therapy areas to understand the global regulatory requirements.
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.