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1. AGGREGATE REPORT INTERVIEW
QUESTIONS
These are some commonly asked questions however you need to have
hands-on training on how to draft these reports

2. What are aggregate reports?
● Aggregate reports are cumulative safety data of medicinal
products, these reports are submitted to regulatory
authorities over a period of time. These reports focus on
compilation of safety data to understand its benefit risk
profile of a medicinal product.Aggregate reports are also
called periodic safety update reports.

3. Types of aggregate report
Pre-marketing reports Post-marketing reports
IND annual reports (US) PBRER/PSUR
Annual safety reports (Europe) PADER (US)
DSUR NDA and ANDA (US)
Health authority responses Addendum to clinical overviews
(ACOs)
DSUR Local safety and benefit-risk reports

4. How many sections are there in PBRER?
● There are 20 sections in the PBRER report including
appendices which form section 20.

5. Which section of PBRER deals with signal and risk
● Section 16 of PBRER reports talk about signal and risk.

6. What is Addendum report?
● An Addendum Report is an update to the most recently
completed PSUR based on Regulatory Authority
requests or requires a safety update outside the usual
IBD reporting cycle mostly for renewal purposes.

7. What is DSUR?
● An Addendum Report is an update to the most recently
completed PSUR based on Regulatory Authority requests
or requires a safety update outside the usual IBD reporting
cycle mostly for renewal purposes.

8. What is PBRER?
● Periodic Benefit Risk Evaluation Reports (PBRERs) are
pharmacovigilance documents for preparation and submission
by marketing authorization holders at defined time points
during the post-authorization phase with objective to provide a
comprehensive, concise and critical evaluation of the risk-
benefit balance of a medicinal product taking into account new
or emerging information in the context of cumulative
information on risks and benefits.

9. Difference between PBRER and PADER?
PBRER PADER
PBRER consists of detailed analysis
on the benefit-risk evaluation of the
given medicinal product.
PADER consists of individual case
narratives for cases with fatal
outcomes and/events of special
interest.
It consists of 20 sections and is a
more complex document.
It consists of around 5 sections and is
relatively less complex document.

10. Visit: www.pharmamentorsedu.coom
It mainly includes sections on
regulatory updates, cumulative and
interval exposure, interventional and
non interventional clinical trials,
overview of signals, and benefit-risk
assessment.
It includes case presentation of
serious unlisted events and regulatory
updates

11. CONTACT
PHARMAMENTORS
Contact: +917400082233/ +19195592228/ +447442607750
Visit: www.pharmamentorsedu.com