Aggregate Safety Reports Services

To protect the safety and efficacy of a drug, the Marketing Authorization Holder (MAH) must conduct aggregate reporting in pharmacovigilance (PV) and safety medical writing activities. They must periodically submit aggregate safety reports, also known as a periodic report or a periodic safety report, to Health Authorities (HAs).

Based on the marketing authorization status, the MAH must prepare different types of reports, including pre-approval and post-marketing reports. These primarily include Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), and Development Safety Update Reports (DSUR). Additionally, many authorities also mandate submission of country specific annexes and local PSURs. Freyr’s Aggregate Safety Reports Services cater to all geographies and ensure compliance to regulatory requirements.

Pre-approval Aggregate Safety Reports

These aggregate safety reports include a cumulative summary of safety information for molecules under clinical development. These reports, such as the DSUR, focus on evaluation of safety information from nonclinical studies and safety data of subjects participating in clinical trials.

Development Safety Update Report (DSUR)

The DSUR document has replaced traditional reports such as Annual Safety Reports (ASRs) in Europe and Investigational New Drug (IND) annual reports in the United States. This harmonization ensures the three ICH regions receive information in the same format, thereby reducing the total number of reports generated. Sponsors are mandated to submit DSURs from the DIBD (development internation birth date) until all clinical studies are closed.

Post-approval Aggregate Safety Reports

These reports provide a cumulative summary of the company's core safety information for medicinal products that are approved/marketed.

The following types of aggregate reports are submitted for medicinal products post-marketing authorization:

• Periodic Adverse Drug Experience Report (PADER)
• Periodic Benefit Risk Evaluation Report (PBRER) or Periodic Safety Update Report (PSUR)
• Summary Bridging Reports
• Addendum to Clinical Overview reports
• Safety Assessment Reports
• Canadian Annual Safety Report documentation
• Ad-hoc Reports (based on HA requests)

Strategic Implementation and Management

The following strategic-level maintenance activities are planned and executed by Freyr's team of experts as part of our comprehensive Aggregate Safety Reports Services:

• Customised template creation and maintenance
• Creation and maintenance of periodic report timetables and calendars
• Literature management for aggregate report generation
• Resource allocation based on expertise and skill set
• Tracking and managing report preparation based on aggregate reporting periods and database lock
• Preparation of line listings and tabulation
• Medical review of draft documents
• Submission to Health Authorities
• Document management and archiving
• Compliance with HA timelines
• Handling and answering HA queries
• SOP creation and maintenance