Pharmacovigilance

PBRER
Advanced Trainer from AUT
Founder of the initiative
‫كبسولة وعي‬

PREPARED BY -DR. SHAIMAA EL.NADI 2022

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 Rules
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 Agenda:
• What is PBRER (PUSR).
• Template of PSUR.
• Break
• Work-Shop.

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What is Pharmacovigilance?

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“The science and activities relating to the
Detection, assessment, understanding and
prevention of adverse drug effects or any other
drug- related problems”

Detection Assessment Understanding Prevention

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Periodic safety update reports (PSURs) are
pharmacovigilance documents intended to provide an
evaluation of the risk-benefit balance of a medicinal product
for submission by marketing authorisation holders at defined
time points during the post-authorisation phase

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Each marketing authorisation holder shall be responsible
for submitting PSURs for its own products
to the national medicines authorities in the Arab Countries
according to the following timelines:
-within 70 calendar days of the data lock point (day 0) for
PSURs covering intervals up to 12 months (including
intervals of exactly 12 months); and
-within 90 calendar days of the data lock point (day 0) for
PSURs covering intervals in excess of 12 months.
- the timeline for the submission of ad hoc PSURs requested
by national medicines authorities will normally be specified
in the request, otherwise the ad hoc PSURs should be
submitted within 90 calendar days of the data lock point.

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Benefit-risk evaluation

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EURD List

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 PBRER is consist of:
1. Part I cover page.

2. Part II executive summary.

3. List of abbreviations, list of tables inside PBRER and table of

content.

4. 20 sections and each subsection.

5. National appendix.

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 Part I:cover page
Periodic Benefit Risk Evaluation Report No“….“
For
Active Substance: ………………
ATC Code: ………………..
Medicinal product: ………………….
International Birth Date (IBD):……………………
Marketing Authorization Holder (MAH): ………………………..
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Interval Covered by This Report: …………………….
Data of Lock Point(DLP): ……………………….
Date of sign off this report: …………………………..
Date of Submission: ……………………………..
Signature:…………..
Contact information for QPPV:……..
Statement of confidentiality:………….

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 An executive summary should be placed immediately after the title page and before
the table of contents. The purpose of the executive summary is to provide a concise
summary of the content and the most important information in the PSUR and
should contain the following information: introduction and reporting interval;
medicinal product(s), therapeutic class(es), mechanism(s) of action, indication(s),
pharmaceutical formulation(s), dose(s) and route(s) of administration; estimated
cumulative clinical trials exposure; estimated interval and cumulative exposure
from marketing experience; number of countries in which the medicinal product is
authorised; summary of the overall benefit-risk analysis evaluation (based on sub-
section 18.2 ―benefit-risk analysis evaluation‖ of the PSUR); actions taken and
proposed for safety reasons, (e.g. significant changes to the reference product
information, or other risk minimisation activities); and conclusions.

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Table of content.

List of abbreviations.

List of tables.

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 A-Actions related to investigational uses (not applicable for
generics)

B-Actions related to marketing experience

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5.1. Cumulative subject exposure in clinical trials
(Not applicable for generic)

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5.2. Cumulative and interval patient exposure from marketing experience:

by calculation of the estimated cumulative patient exposure by IMS

(International Marketing Sales) data. Cumulative patient exposure
= Sales / Recommended daily dose= ? / 365.25= ? patient/year.

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Section 6: "Data in summary tabulations"
6.1. Reference information: (MedDRA..)

6.2. Cumulative summary tabulations of serious adverse events from

clinical trials:
(Not applicable for generics)

6.3. Cumulative and interval summary tabulations from post-marketing

data sources.

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Section 7: "Summaries of significant findings from
clinical trials during the reporting interval"
(Not applicable for generics)

7.1. Completed clinical trials.

7.2. Ongoing clinical trials.
7.3. Long-term follow-up.
7.4. Other therapeutic use of medicinal product.
7.5. New safety data related to fixed combination therapies.

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9.1. Other clinical trials :( not applicable for generics)
9.2. Medication errors

(Not applicable for generics)

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 Break

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(Not applicable for generics)

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MAH should provide a tabulation of all signals ongoing or closed at the end of the
reporting interval. This tabulation should include the following information:
•A brief description of the signal.
•Date when marketing authorization holder became aware of the signal.
•Status of the signal at the end of the reporting interval (close or ongoing).
•Date when signal was closed, if applicable.
•Source of the signal.
•Brief summary of the key data.

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•Plans for further evaluation, and
•Action taken or planned.

The methods of signal detection can be:

•Review of cases and estimated incidence.
•Non clinical and clinical study results.
•Literature searches.
•Epidemiological data and post authorization studies results.
•Any other information provided in the context of regulatory procedures or ongoing benefit-risk monitoring
if applicable.

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16.1. Summaries of safety concerns
16.2. Signal evaluation
16.3. Evaluation of risks and new information
16.4. Characterization of risks

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Safety concern

Frequency with 95% CI

Seriousness/ outcomes

Severity and nature of

risk

Background
incidence/prevalence

Risk groups or risk

factors

Potential mechanism

Preventability

Impact on individual
patient

Potential public health

impact of safety concern

Evidence source(s)

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16.5. Effectiveness of risk minimization (if applicable)
measure effectiveness of any risk minimization tools
Safety concern

Effectiveness of risk minimization measures

How Any significant number of spontaneous ADR cases of Safety

effectiveness of concerns is received or corresponding information in published
risk literature would indicate possible lack of efficacy of current risk
minimization minimization measures.
measures for the
safety concern
will be measured
Results of NO significant increase in number of spontaneous ADR cases of
effectiveness Safety concerns was detected.
measurements

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17.1. Important baseline efficacy and effectiveness information.
17.2. Newly identified information on efficacy and effectiveness.
17.3. Characterization of benefits.

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18.1. Benefit-risk context- Medical need and important alternatives.
18.2. Benefit-risk analysis evaluation.

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List of Appendices:
1. Reference information.
2. Cumulative summary tabulations of serious adverse events from clinical
trials; and cumulative and interval summary tabulations of serious and
non-serious adverse reactions from post-marketing data sources.
3. Tabular summary of safety signals (if not included in the body of the
report).

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4-Listing of all the marketing authorization holder-sponsored interventional and non-
interventional studies with the primary aim of identifying, characterizing, or
quantifying a safety hazard or confirming the safety profile of the medicinal product, or
of measuring the effectiveness of risk management measures, in case of non-
interventional studies. Final study reports for those which were completed during the
reporting interval should also be included as reports for those which were completed
during the reporting interval.

5-List of sources of information used to prepare the PBRER (when desired by the
marketing authorization holder).

6-National appendix.

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6-National appendix
1-Current national product information.
2-Proposed product information if any.
3-Proposed additional pharmacovigilance and risk minimization activities
(if applicable).
4-Summary of ongoing safety concerns.
5-Worldwide marketing authorization status table.

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 5-Worldwide marketing authorization status table

First
Current
approval Current Application
Local trade Dosage marketing Refusal Comments/
date/ Country Indications authorization Date refusal (if
name form(s) status& date explanation
application status any)
date
date

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Shaimaa El.Nadi Hassan El.Nadi
Mobile No: 01061034133
Email:
elnadis@yahoo.com
shaimaaelnadi@gmail.com

PREPARED BY -DR. SHAIMAA EL.NADI 2022

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