Grab-Bag
Where (e.g., region) is the PBRER mandated?
EU/EEA, but may also be required as per local regulations in other regions
In what section should you summarize any major safety findings from in vivo or in vitro studies from the interval?
10. Non-Clinical Data
In what section is a summary of ALL signals for the interval (both ongoing and closed) presented?
15. Overview of Signals: New, Ongoing or Closed
What 3 types of safety concerns should be discussed in Section 16.1 Summary of Safety Concerns?
• Important identified risks
• Important potential risks
• Missing information
What formula can be used to calculate reporting rate per 100,000 patient-years?
# Events / Exposure (Patient-Years) x 100,000
What must be in place for a study to be considered as "completed?"
Final (signed) Clinical Study Report (CSR)
In what sub-section do you evaluate all signals CLOSED during the reporting interval?
16.2 Signal Evaluation
What format is recommended to be used for Section 16.4 Characterization of Risks?
Follow EU RMP template format
Information from WHEN (what point in time) should be covered in section 17.1 Important Baseline Efficacy/Effectiveness Information?
Summarize information on the efficacy/ effectiveness as of the BEGINNING of the reporting interval
What section of the PBRER should "stand alone" from the rest of the report?
Executive Summary
What is the expected citation/reference style for literature citations?
Vancouver style
In the context of signal detection, what is the first question to consider for a potential signal?
Is this a previously recognized risk?
Information from WHEN (what point in time) should be covered in section 16.1 Summary of Safety Concerns?
Should summarize safety concerns known at the BEGINNING of the reporting interval
In what section would you present efficacy results from a Company-sponsored trial's recent interim analysis that occurred during the reporting interval?
17.2 Newly Identified Information on Efficacy/Effectiveness
In applicable region(s), at what point in the Lifecycle of a product do PBRERs become a requirement?
Upon marketing authorization, and it will continue to be required indefinitely
In what 2 sections within the "Data Presentation" sections should you mention any signals that were identified in the literature during the interval?
11. Literature & 15. Overview of Signals: New, Ongoing or Closed
What are the 2 possible outcomes of signal evaluation?
1. Refuted
2. Risk
In what sub-section would you summarize the results from a survey sent out to HCPs to measure understanding of a recent "Dear Dr." letter?
16.5 Effectiveness of Risk Minimization
If a competitor launched a new product to market during the interval that has the same indication as your product, what section would need to be updated?
18.1 Benefit-risk context - medical need and important alternatives
Should investigator-initiated trials be included in the Clinical Trial Cumulative Subject Exposure tables?
This section only applies if…
•Clinical Trial occurred / completed during the interval.
•Lack of efficacy would result in serious or life-threatening outcome (i.e., based on indication)
Where should you present any close monitoring events (CMEs) that were previously requested by a regulatory authority but were previously determined NOT to be a signal?
CMEs should be presented separately under Section 15.
A safety concern (closed signal or risk) for the interval should be presented in ONE of these TWO sub-sections in Section 16, but not BOTH. What are the two sub-sections?
16.2 Signal evaluation
OR
16.3 Evaluation of risks and new information
In what section should you discuss uncertainties, weaknesses, or limitations of the evidence?
18.2 Benefit-risk analysis evaluation