Name that KSD
Periodic aggregate report used to assess the overall
benefit-risk profile of marketed products
PERIODDIC BENEFIT-RISK EVALUATION REPORT
Acts as key support to GSO for SER development
PHARMACOVIGILANCE SCIENTIST (PVS)
PBRER and DSUR need the SER’s conclusion from here
SOLAR / Signal Management Tool
In order to have smooth, effective and quality KSD,
this is done rigorously
ROUTINE SAFETY SURVEILLANCE
In this PBRER section issues related to the use of the product are described, as well as patterns if any, and the root cause of the events are explained
PBRER MEDICATION ERRORS (9.2)
Describes assessment of a safety topic after a signal is validated
SAFETY EVALUATION REPORT
Responsible for establishing, driving and communicating the safety strategy that governs the monitoring and surveillance of product risks and safety issues
GLOBAL SAFETY OFFICER (GSO)
PV associates need to have this type of mindset for the
PBRER Evaluation of risks and new information (16.3)
STRATEGIC
Routine safety surveillance is connected to these four
KSD covered in this learning journey
SER, HHE, PBRER, HASR response
This safety strategy of monitoring must be put in place by the GSO and must be available as soon as the new product is on the market
LIST OF SAFETY TOPICS
Defines and documents the safety monitoring strategy
through the development phases of the product
DEVELOPMENT RISK MANAGEMENT PLAN
Sends Rapid Quality Notification and HHE request
form to GPV mailbox
QUALITY INDUSTRIAL AFFAIRS
GSO and PVS need these two to narrow down cases retrieved to only the relevant cases for SER assessment
CASE DEFINITION AND STRATEGY
This might need to be updated after a signal has been categorized as important risk
RISK MANAGEMENT PLAN (RMP)
This is a tool available to use when mapping PBRER sections related to signal and risk evaluation that could be impacted by new safety information
SIGNAL AND RISK FLOWCHART
The Reference Safety Information until the
product is marketed
INVESTIGATOR’S BROCHURE
Receives HASRs from EMA and FDA
GLOBAL REGULATORY AFFAIRS (GRA)
This needs to be consistent in the BR section of the PBRER, and in other corresponding sections of KSD based on the available studies and safety evaluations
BR PROFILE/MESSAGE ON EFFICACY AND SAFETY
These two KSD have the following similar sections: ‘Safety Findings from Marketing Experience’, ‘Evaluation of Risks’, ‘Benefit-Risk Considerations’, ‘Summary of Important Risks’
DSUR AND PBRER
This safety governance body endorses, for example, the safety evaluation done by the GSO of a potentially life-threatening impact of a product defect in patients
SIGNAL MANAGEMENT COMMITTEE (SMC)
Detailed report consisting of the methods and results of a clinical trial both for efficacy and safety data incorporating also the relevant safety narratives
CLINICAL STUDY REPORT
2 strong non-PV contributors in providing the insights for the anticipated efficacy & benefit of DSUR’s BR considerations section
(PRODUCT) CLINICAL AND MEDICAL (LEAD)
Health authorities need these 2 pieces of information for the description of a pattern of a medication error on top of Description of error, Number of occurrences up to data lock point, Comments
ANALYSIS OF CAUSE, STEPS TAKEN TO PREVENT
THE ERROR
Two KSD recommended to be prepared in parallel during clinical development
IB AND DSUR
This result of an annual survey determines the product’s aggregate Signal Detection review periodicity
PRODUCT PRIORITY CATEGORY