Pharmacovigilance planning is a systematic approach to ensuring the safety of pharmaceutical products, including drugs and medical devices, once they are approved and available in the market. It involves creating strategies, processes, and systems to monitor, detect, assess, and prevent adverse effects or other drug-related problems throughout the product's lifecycle. The ultimate goal of pharmacovigilance planning is to protect patient safety and public health by minimizing risks associated with the use of medical products.

1. Welcome
Pharmacovigilance Planning
Khoriwale Wahidoddin.S
B-Pharmacy
167/082023
25/08/2023
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2. Contents
1. Definition
2. Pharmacovigilance planning
3. Why Pharmacovigilance Planning
4. Why guidelines are needed
5. Guidelines
6. Scope
7. Why guidelines are needed
8. Safety Specification
9. Elements of safety specification
10. Pharmacovigilance Plan
11. Structureof the PharmacovigilancePlan
12. Summary of ongoing safety issues
13. Routine Pharmacovigilance Practices
14. Summary of actions to be completed, including milestones
15. References
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3. Definition:
Pharmacovigilance:
Pharmacovigilance is the scientific discipline and set of activities focused on the
detection, assessment, understanding, and prevention of adverse effects or any other
drug-related problems associated with pharmaceutical products. It involves the
systematic collection, analysis, evaluation, and reporting of information related to the
safety and efficacy of medications after they have been approved and made available
to the public. The primary aim of pharmacovigilance is to enhance patient safety by
identifying and minimizing the risks associated with the use of medications while
maximizing their therapeutic benefits.
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4. Pharmacovigilance planning:
 Pharmacovigilance plan especially in preparation for the early postmarketing period of a new drug.
 Pharmacovigilance Plan that might be submitted at the time of license application.
 Pharmacovigilance plan can be used by sponsors to develop a stand-alone document for regions that
prefer this approach Pharmacovigilance Plan into the Common Technical Document (CTD).
 Pharmacovigilance planning refers to the systematic process of designing, organizing, and
implementing strategies and procedures to monitor, assess, and manage the safety of pharmaceutical
products throughout their lifecycle. It involves establishing protocols, resources, and workflows to
systematically collect, analyze, and report information about adverse events, adverse reactions, and
other safety-related data associated with medications. The goal of pharmacovigilance planning is to
ensure the early detection, evaluation, and effective management of potential risks, thereby
enhancing patient safety and regulatory compliance in the field of healthcare and pharmaceuticals.
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5. Why Pharmacovigilance Planning
Pharmacovigilance planning is a crucial aspect of ensuring the safety and effectiveness of
medications. It involves the systematic collection, assessment, monitoring, and communication of
information about the safety of drugs and medical products. Here's why pharmacovigilance
planning is essential:
1. Patient Safety
2. Regulatory Compliance
3. Public Health
4. Risk Management
5. Signal Detection
6. Data-driven Decisions
7. Global Collaboration
8. Continuous Improvement:
9. Emerging Technologies
Carefully planned and effective pharmacovigilance activities, particularly, can reduce the risk of drug
toxicity and increase the benefit of public health.
Robust safety data can help avoid the withdrawal of effective drugs from the market.
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6. Why guidelines is needed
• Carefully planned and effective pharmacovigilance activities, particularly for new drugs, can reduce
the risk of drug toxicity and increase the benefit to public health.
• Robust safety data can help avoid the withdrawal of effective drugs from the market.
• There is a need for an ICH guideline on this topic to ensure harmonization and consistency, prevent
duplication of effort, and minimize risk to public health.
• In addition, the guideline may be of benefit to public health programs throughout the world when
considering new drugs in their country.
• The guideline could be used by the industry: when preparing a pharmacovigilance plan in discussions
with regulators during the licensing assessment
• When preparing to launch a product in case of safety concerns in the post-marketing period guidelines
will be particularly relevant to new chemical entities and biotechnology-derived products, as well as
significant changes in established products and those that are to be introduced to new populations or
in significant new indications.
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7. Guidelines
• Guidelines are intended to aid in planning pharmacovigilance activities,
especially in preparation for the early postmarketing period of a new drug (in
this guideline, the term "drug" denotes chemical entities, biotechnology-derived
products, and vaccines).
• This guideline’s main focus is on a Safety Specification and Pharmacovigilance
Plan that might be submitted at the time of license application.
• Guidelines can be used by sponsors to develop a stand-alone document for
regions that prefer this approach or to provide guidance on the incorporation of
elements of the Safety Specification and Pharmacovigilance Plan into the
Common Technical Document (CTD)
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8. The guideline describes a method for summarising:
• Important identified risks of a drug.
• Important potential risks of a drug
• Important missing information (including the potentially at-risk populations and
situations where the product is likely to be used that have not been studied pre-
approval)
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9. Scope
• The purpose of this guideline is to propose a structure for a
Pharmacovigilance Plan, and Safety Specification that summarises the
identified and potential risks of the product to be addressed in the plan. The
guideline is divided into the following sections.
1. Safety Specification
2. Pharmacovigilance Plan
• During the course of implementing the various components of the plan, any
important emerging benefit or risk information should be discussed and
used to revise the plan.
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10. The guidelines principles
• Planning pharmacovigilance activities throughout the Product life-cycle.
• A science-based approach to risk documentation.
• Effective collaboration between regulators and industry.
• Applicability of the Pharmacovigilance plan across the three ICH regions.
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11. Safety Specification
• The Safety Specification should be a summary of;
 The important identified risks of a drug Important potential risks
 Important missing information
 It should also address the population potentially at risk (where the product
is likely to be used) Outstanding safety questions which warrant further
investigation to refine the understanding of the benefit-risk profile during
the post-approval period.
 This Safety Specification is intended to help industry and regulators
identify any need for specific data collection and also to facilitate the
construction of the Pharmacovigilance Plan.
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12. Elements of Safety Specification:-
The focus of the Safety Specification should be on the identified risks,
important potential risks, and important missing information. The following
elements should be considered
1.Non-Clinical
2.Clinical
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13. Non-Clinical:
1. Toxicity (including repeat-dose toxicity,
reproductive/developmental toxicity, nephrotoxicity,
hepatotoxicity, genotoxicity, carcinogenicity, etc.
2. General pharmacology (cardiovascular, including
QT interval prolongation; nervous system; etc.);
3. Drug-interactions;
4. Other toxicity-related information or data.
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14. Clinical:
a. Limitations of the Human Safety Database
The worldwide experience should be briefly discussed, including:
 The extent of the worldwide exposure
 Any new or different safety issues identified
 Any regulatory actions related to safety
b. Populations not Studied in the Pre-Approval Phase Children
 The elderly
 Pregnant or lactating women
 Patients with relevant co-morbidity such as hepatic or renal disorders
 Patients with disease severity different from that studied in clinical trials
 Sub-populations carrying known and relevant genetic polymorphism
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15. c. Adverse Events (AEs) / Adverse Drug Reactions(ADRS): More detailed information should be
included on the most important identified AES/ADRs, which would include those that are serious
or frequent and that also might have an impact on the balance of benefits and risks of the product.
d. Identified and Potential Interactions, Including
e. Epidemiology (incidence, prevalence, mortality, and Food-Drug and Drug-Drug Interactions
relevant co-morbidity, and should take into account whenever possible stratification by age, sex,
and racial and/or ethnic origin).
f. Pharmacological Class Effects (The Safety Specification should identify risks believed to be
common to the pharmacological class.)
At the end of the Safety Specification, a summary should be provided of the:
• Important identified risks
• Important potential risks
• Important missing information
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16. Pharmacovigilance Planning
The Pharmacovigilance Plan should be based on the Safety Specification.
The Specification and Plan can be written as two parts of the same document. The Plan would
normally be developed by the sponsor and can be discussed with regulators during product
development, before approval (i.e., when the marketing application is submitted) of a new product,
or when a safety concern arises post-marketing.
It can be a stand-alone document but elements could also be incorporated into the CTD.
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17. STRUCTURE OF A
PHARMACOVIGILANCE PLAN:
The structure can vary depending on the product in question and the issues
identified in the Safety Specification. The plan should be updated as soon
as important safety information becomes available.
1. Summary of Ongoing Safety Issues:
• At the beginning of the Pharmacovigilance Plan, a summary should be
provided of the:
• Important identified risks;
• Important potential risks;
• Important missing information.
This is important if the Pharmacovigilance Plan is a separate document
from the Safety Specification
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18. 2. Routine Pharmacovigilance Practices should be conducted for all medicinal
products, regardless of whether or not additional actions are appropriate as part
of a Pharmacovigilance Plan. This routine pharmacovigilance should include the
following:
 Systems and processes that ensure that information about all suspected
adverse reactions that are reported to the personnel of the company are
collected and collated in an accessible manner;
The preparation of reports for regulatory authorities:
o Expedited adverse drug reaction (ADR) reports;
o Periodic Safety Update Reports (PSURS).
 Continuous monitoring of the safety profile of approved products
including signal detection, issue evaluation, updating of labeling, and
liaison with regulatory authorities;
 Other requirements, as defined by local regulations
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19. 3. Action Plan for Safety Issues:
The Plan for each important safety issue should be presented and justified according to the
following structure:
• Safety issue;
• Objective of proposed action(s);Action(s) proposed;
• Rationale for proposed action(s);
• Monitoring by the sponsor for safety issues and proposed action(s)
• Milestones for evaluation and reporting.
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20. 4. Summary of Actions to be Completed, Including Milestones
In this section, the Pharmacovigilance Plan for the product should be organized in terms of the
actions to be undertaken and their milestones.
The reason for this is that one proposed action (e.g., a prospective safety cohort study) could address
more than one of the identified issues.
It is recommended that milestones for completion of studies and other evaluations, and submission
of safety results, be included in the Pharmacovigilance Plan. Things to be considered when
developing the milestones:
• Exposure to the product will have reached a level sufficient to allow potential
identification/characterization of the AES/ADRS of concern or resolution of a particular
concern: and/or
• The results of ongoing or proposed safety studies are expected to be available. These milestones
might be aligned with regulatory milestones (e.g., PSURS, annual reassessment, and license
renewals) and used to revise the Pharmacovigilance Plan.
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21. Reference
1.https:/www.ich.org/efficacy-guidelines/e2eguidelines
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22. Thank You!
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