Overview

In order to protect the safety and efficacy of a drug, manufacturers need to submit safety reports to Health Authorities (HAs) periodically which otherwise known as, periodic safety reports (PSRs). Even a single data error while submitting the reports might lead to huge cost to companies.

Freyr team has expertise in authoring content, coordinating reviews, performing the quality check, and project management of various Health Authority periodic safety reports/aggregate reports. With a comprehensive knowledge of PV process and safety obligations to the HAs, Freyr strategic level maintenance activities are well planned and executed as below:

  • Creation/Maintenance of periodic safety report timetable/calendars
  • Resource allocation based on the expertise and skill set
  • Tracking and managing preparation of reports based on reporting time period and database lock
  • Submission to HA
  • Compliance to HA timelines
  • Handling and responding to HA queries
 

Freyr Expertise

  • Periodic Adverse Drug Experience Reports (PADERs)
  • Periodic Benefit Risk Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSUR)
  • Developmental Safety Update Reports (DSURs)
  • Canadian Annual Summary Reports (CASR)
  • Risk Management Plans (RMPs)
  • Risk Evaluation and Mitigation Plans (REMPs)  
  • Addendum Clinical Overviews (ACOs)
  • Safety Assessment Reports (SARs),
  • Safety Narratives (Brief and Full narratives)
 

Freyr Advantages

  • Single point of contact for the entire range of safety services including ICSR, Aggregate reports, Qualified Person Responsible for PV (QPPV) services, the US Agent services, Signal Detection & Evaluation, database migration, adverse event reconciliation, and local affiliate services
  • Initial kick-off to submissions to HA and handling/addressing HA queries
  • In-depth safety knowledge perfectly integrated with required IT capabilities
  • Expertise in ICSR case management including case triage/book-in, case processing, narrative writing, medical review, quality control and submission
  • Staff with hands-on experience in handling/managing standard and customized safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac to name few
  • Expertise in writing aggregate safety documents as per various health authority and submission requirements like Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Periodic Adverse Drug Experience Report (PADERs), Annual Safety Report (ASRs), Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS), any other country specific reports, etc.
  • Expertise in setting up PV systems and processes, PV Database Evaluation, PV Database Validation, Harmonization, writing SOPs and training employees as per local Regulatory requirements in various geographies
  • Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA) and remediation activities
  • Extensive experience in PV process harmonization and creation of  Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
  • Experience in tracking safety variations and PV System Master File (PSMF) compliance
  • Defined processes of thorough scientific, medical, editorial and quality control review
  • Timely delivery with the highest standard of quality
  • Expert program and project management support to maintain compliance