What is Safety Writing & Aggregate Reporting?

Safety Writing.

Pharmacovigilance medical safety writing is a critical requirement in every stage of drug development, approval, and post marketing. It is a fundamental part of developing all the documentation that defines, guides, and supports pharmacovigilance activities.

This process requires individuals with exceptional expertise and a clear understanding of a wide variety of scientific concepts, together with current regional and national regulations and guidelines.

The creation of each document or report written necessitates a high degree of precision and adherence to specific deadlines, which is why pharmacovigilance medical safety writing juggles multiple tasks concurrently.

Typical Safety Writing documentation for pharmacovigilance includes:

Clinical Trial Protocols
Investigators′ Brochure
Informed Consent Documents
Study reports
Research proposals
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)

Click for more information from the EMA on DSURs.

Click for more information from the EMA on PSURs.

Aggregate Reporting.

During a product’s lifecycle, from clinical onwards, safety information and data continuously accumulate. At different points and for different requirements, this information needs to be ‘aggregated’ into specific periodic reports.

Aggregate reports are based on E2C guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and their overarching goal throughout a product’s life cycle is to establish and demonstrate an understanding about its efficacy and Benefit-Risk Profile, which can evolve over time as more Real-World Data becomes available.

Typical Aggregate Reports are:

Development Safety Update Reports (DSURs): These reports follow the ICH format for Periodic Benefit-Risk Evaluation Reports (PBRERs) and offer a comprehensive overview of the benefit-risk assessment and safety data concerning an investigational medicinal product during its developmental phases. DSURs are submitted at defined intervals throughout the clinical trial period.
Periodic Safety Update Reports (PSURs): These reports provide a comprehensive periodic evaluation of the global safety data associated with a marketed product. They are essential because they encompass the expanding pool of real-world safety data once the product is launched, in contrast to the limited controlled data derived from the product’s clinical trials.
Line Listings: Line Listings typically represent database exports of safety data, offering essential key information but without the comprehensive details found in other reports.

Click for information on the ICH Efficacy Guidelines.

Why use Aegisana’s Safety Writing and Aggregate Report services?

Reporting expertise.

Aegisana’s Clinical Safety and Pharmacovigilance experts are fully experienced in the requirements of Safety Writing and Aggregate Report creation and submissions.

Whether your product is in development or on the market we have a solution that can support all your scheduling and preparation needs.

Efficient & competent.

Our objective is to establish trust, confidence, and peace of mind through efficient and competent delivery of all your writing and reporting obligations.

We are dedicated to upholding the most stringent technical standards to support you through development and the continued marketing of successful products that benefit patients.