Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Clinical Studies - Foundational to the Drug Approval ProcessJohn Kriak
One of the key elements in gaining approval of a drug by the US Food and Drug Administration (FDA) involves clinical research. There are two primary avenues of such research: clinical trials and observational studies. The latter involves monitoring subjects within normal settings, with data gathered over time and health changes evaluated and compared with others in the group.
Drug discovery is a
process which aims
at identifying a
compound
therapeutically useful
in curing and treating
disease
Target identification is process of
identifying the direct molecular
target(protein, nucleic acid, or
small molecule).
Identifying the biological of the
disease and the potential targets
for involvement ,is the first step in
the discovery of a medicine
To study new drug registration process in u.sManoj Dagwar
Legislative History of Drug Regulation
Derived from the Dutch word meaning to boast (quacken), “quack” is the word Americans have commonly used to describe charlatans in medicine. Quacks peddled adulterated and mislabeled Medicines throughout the United States without penalty until 1906, when Congress passed the Food and Drugs Act, one section of which outlawed the practice.
Over the next half-century, Congress passed two major pieces of legislation expanding FDA Authority. It passed the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1938, requiring that
Drugs be proven safe before they could be sold in interstate commerce. Then, in 1962, in the wake of deaths and birth defects from the tranquilizer thalidomide marketed in Europe, Congress passed the Kefauver-Harris Drug Amendments to the FFDCA,3 increasing safety provisions and
Requiring that drugs be proven effective as well.
Congress has amended the FFDCA many times, leading to FDA’s current mission of assuring
Americans that the medicines they use do no harm and actually work—that they are, in other words, safe and effective. In recent decades Congress has passed additional laws to boost
Pharmaceutical research and development and to speed the approval of new medicines.
FDA also regulates products other than drugs—for example, biological products, medical devices,
Dietary supplements, foods, cosmetics, animal drugs, and tobacco products. Sometimes the
Agency addresses issues that straddle two or more product types that the law treats differently.
How FDA Approves New Drugs
To market a prescription drug in the United States, a manufacturer needs FDA approval. to get that approval, the manufacturer must demonstrate the drug’s safety and effectiveness according to criteria specified in law and agency regulations, ensure that its manufacturing plant passes FDA inspection and obtain FDA approval for the drug’s labeling—a term that includes all written material about the drug, including, for example, packaging, prescribing information for physicians, and patient brochures.
The approval process begins before the law requires FDA involvement. Figure 1 illustrates a product’s timeline both before and during FDA involvement.
The research and development process for a finished drug usually begins in the laboratory. Basic research is often conducted or funded by the federal government.7 when basic research yields an idea that someone identifies as a possible drug component, government or private research groups focus attention on a prototype design. At some point, private industry (either a large, established company or a newer, smaller, start-up company) continues to develop the idea, eventually testing the drug in animals. When the drug is ready for testing in humans, the FDA must get involved.
The Standard Process of Drug Approval
The four FDA steps leading to the agency’s approval of a new drug for marketing in the United
States are described below.
this slide share will provide information about drug discovery and development.in this, how the drug is discovered and what type of procedures and instructions followed during discovery and development of a new drug and also give limitations of drug discovery and development process.
Clinical Studies - Foundational to the Drug Approval ProcessJohn Kriak
One of the key elements in gaining approval of a drug by the US Food and Drug Administration (FDA) involves clinical research. There are two primary avenues of such research: clinical trials and observational studies. The latter involves monitoring subjects within normal settings, with data gathered over time and health changes evaluated and compared with others in the group.
Drug discovery is a
process which aims
at identifying a
compound
therapeutically useful
in curing and treating
disease
Target identification is process of
identifying the direct molecular
target(protein, nucleic acid, or
small molecule).
Identifying the biological of the
disease and the potential targets
for involvement ,is the first step in
the discovery of a medicine
To study new drug registration process in u.sManoj Dagwar
Legislative History of Drug Regulation
Derived from the Dutch word meaning to boast (quacken), “quack” is the word Americans have commonly used to describe charlatans in medicine. Quacks peddled adulterated and mislabeled Medicines throughout the United States without penalty until 1906, when Congress passed the Food and Drugs Act, one section of which outlawed the practice.
Over the next half-century, Congress passed two major pieces of legislation expanding FDA Authority. It passed the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1938, requiring that
Drugs be proven safe before they could be sold in interstate commerce. Then, in 1962, in the wake of deaths and birth defects from the tranquilizer thalidomide marketed in Europe, Congress passed the Kefauver-Harris Drug Amendments to the FFDCA,3 increasing safety provisions and
Requiring that drugs be proven effective as well.
Congress has amended the FFDCA many times, leading to FDA’s current mission of assuring
Americans that the medicines they use do no harm and actually work—that they are, in other words, safe and effective. In recent decades Congress has passed additional laws to boost
Pharmaceutical research and development and to speed the approval of new medicines.
FDA also regulates products other than drugs—for example, biological products, medical devices,
Dietary supplements, foods, cosmetics, animal drugs, and tobacco products. Sometimes the
Agency addresses issues that straddle two or more product types that the law treats differently.
How FDA Approves New Drugs
To market a prescription drug in the United States, a manufacturer needs FDA approval. to get that approval, the manufacturer must demonstrate the drug’s safety and effectiveness according to criteria specified in law and agency regulations, ensure that its manufacturing plant passes FDA inspection and obtain FDA approval for the drug’s labeling—a term that includes all written material about the drug, including, for example, packaging, prescribing information for physicians, and patient brochures.
The approval process begins before the law requires FDA involvement. Figure 1 illustrates a product’s timeline both before and during FDA involvement.
The research and development process for a finished drug usually begins in the laboratory. Basic research is often conducted or funded by the federal government.7 when basic research yields an idea that someone identifies as a possible drug component, government or private research groups focus attention on a prototype design. At some point, private industry (either a large, established company or a newer, smaller, start-up company) continues to develop the idea, eventually testing the drug in animals. When the drug is ready for testing in humans, the FDA must get involved.
The Standard Process of Drug Approval
The four FDA steps leading to the agency’s approval of a new drug for marketing in the United
States are described below.
this slide share will provide information about drug discovery and development.in this, how the drug is discovered and what type of procedures and instructions followed during discovery and development of a new drug and also give limitations of drug discovery and development process.
BOTECHNOLOGY IS CHALLENGING SUBJECT TO TEACH AND UNDERSTAND ALSO .....THEIR INTERESTING PART IS TO LEARN ABOUT PRODUCTION OF CITRIC ACID , PENICILLIN, GLUTAMIC ACID , GRISIOFULVIN , VITAMIN B 12
BOTECHNOLOGY IS CHALLENGING SUBJECT TO TEACH AND UNDERSTAND ALSO .....THEIR INTERESTING PART IS TO LEARN ABOUT MICROBIAL BIO TRANSFORMATION WITH BIOCHEMICAL REACTIONS
BIOTECHNOLOGY IS CHALLENGING SUBJECT TO TEACH AND UNDERSTAND ALSO .....THEIR INTERESTING PART IS TO LEARN ABOUT IMMUNITY AND THE IMPORTANT PART MAJOR COMPATIBILITY COMPLEX
OTECHNOLOGY IS CHALLENGING SUBJECT TO TEACH AND UNDERSTAND ALSO .....THEIR INTERESTING PART IS TO LEARN ABOUT MICROBIAL GENETICS AND THEIR METHODS OF GENE TRANSFER
BIOTECHNOLOGY IS CHALLENGING SUBJECT TO TEACH AND UNDERSTAND ALSO .....THEIR INTERESTING PART IS TO LEARN ABOUT IMMUNITY AND THE IMPORTANT PART MAJOR COMPATIBILITY COMPLEX
BIOTECHNOLOGY IS
CHALLENGING SUBJECT TO TEACH AND UNDERSTAND ......
ITS A VERY INTERESTING TO LEARN ABOUT HYBRIDOMA TECHNOLOGY .. THEIR PRODUCTION AND
APPLICATION ALSO ....
Biotechnology is challenging subject to teach and understand also..its a very interesting subject in pharmacy..all the power point is made as per your syllabus with point to point discussion.
Biotechnology is challenging subject to teach and understand also..its a very interesting subject in pharmacy..all the power point is made as per your syllabus with point to point discussion.
thank you
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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CLINICAL TRIALS.pptx
1. DRUG DISCOVERY AND
CLINICAL EVALUATION OF
NEW DRUGS
BY
ASAWE TEJASWINI L
DEPARTMENT OF PHARMACOLOGY
ASSIASTANT PROFESSOR
SIDHHIS INSTITUTE OF PHARMACY
THANE
2. DRUG DISCOVERY AND
CLINICAL EVALUATION OF
NEW DRUGS
CONTENT
DRUG DISCOVRY PROCESS
PRECLINICAL STUDIES
CLINICLE TRIALS
3. Drug discovery process, involves identification of a drug
chemical therapeutically useful in treating and management of
a disease condition.
Typically, researchers find out new drugs through new
visions into a disease process that permit investigator to design
a medicine to stopover or contrary the effects of the disease.
The process of drug discovery includes the identification of
drug candidates, synthesis, characterization, screening, and
assays for therapeutic efficacy.
When a molecule avails its satisfactory results in these
investigations, it will commence the process of drug
development subsequent to clinical trials.
Drug discovery and development is an expensive process due
to the high budgets of R&D and clinical trials.
It takes almost 12-15 years to develop a single new drug
molecule from the time it is discovered when it is available in
market for treating patients.
4. The average cost for research and development for each
efficacious drug is likely to be $900 million to $2 billion.
This figure includes the cost of the thousands of failures: For
every 5,000-10,000 compounds that enter the investigation and
development pipeline, ultimately only one attains approval.
The Success requires immense resources the best scientific
and logical minds, highly sophisticated laboratory and
technology; and multifaceted project management.
It also takes persistence and good fortune.
Eventually, the process of drug discovery brings hope, faith
and relief to billions of patients.
5.
6. Stages of drug discovery and
development include:
Stages of drug discovery and development
include:
Target identification
Lead discovery
Medicinal chemistry
In- vitro studies
In Vivo studies (pre-clinical)
Preclinical research
Clinical trials
New Drug Application
Approval
7. 1.Target Identification
This is initial phase of the drug discovery pipeline.
Before you can develop a drug , there needs to be The
identification of specific target to design drug .
The targets can be genes, epigenetic , proteins , RNA, or
anything involved in disease pathogenesis.
An ideal target should be efficacious, safe, meet clinical
and commercial requirements.
The techniques used for target identification may be based
on principles of molecular biology, biochemistry, genetics,
biophysics.
8. 2.Lead discovery
Chemical compound designed to interact with
specified targets are synthesized and isolated.
This step involves combinatorial chemistry ,
assay development to screen selected
compound .
The assay depending upon target and
function.
9. 3. Medicinal chemistry
This phase involves developing a library of
compounds and their analogs towards a target
and conducting structure-activity-relationship
(SAR) studies.
10. 4.In- vitro studies-
In- vitro studies investigate drug
affinity towards its target and
selectivity.
Cell culture system relevant to the
disease in question are used .
Mechanism of action of the compound
is questioned.
11. 5.In Vivo studies (pre-clinical)
When lead compounds have been
optimized and characterized to an
acceptable level, in vivo studies are
undertaken.
The mice and rats are used for this
studies.
This studies helps to identify the drug
metabolism and clearance, immune
response, ability of drug to get into
circulation and reach target sites.
12. Preclinical Testing
Pre-clinical research in drug development process involves evaluation of
drug‘s safety and efficacy in animal species that conclude to prospective
human outcome.
The pre-clinical trials also have to acquire approval by corresponding
regulatory authorities.
The regulatory authorities must ensure that trials are conducted in safe and
ethical way and would give approval for only those drugs which are confirm
to be safe and effective.
ICH has established a basic guideline for technical necessities of acceptable
preclinical drug development.
The pre-clinical trials can be conducted in two ways: General pharmacology
and Toxicology.
Pharmacology deals with the pharmacokinetic and pharmacodynamic
parameters of drug.
It is essential to explore unwanted pharmacological effects in suitable animal
models and monitoring them in toxicological studies
Pharmacokinetic studies are very important to make known the safety and
efficacy parameters in terms of absorption, distribution, metabolism and
excretion.
13. Clinical Research
Clinical trials are conducted in people (volunteer)and intended to
answer specific questions about the safety and efficacy of drugs,
vaccines, other therapies, or new methods of using current
treatments.
Clinical trials follow a specific study protocol that is designed by the
researcher or investigator or manufacturer.
As the developers design the clinical study, they will consider what
they want to complete for each of the different Clinical Research
Phases and starts the Investigational New Drug Process (IND), a
process they must go through before clinical research begins.
Before a clinical trial begins, researchers review prior information
about the drug to develop research questions and objectives.
Then, they decide:
Selection criteria for participants
Number of people take part of the study
Duration of study
Dose and route of administration of dosage form
Assessment of parameters
Data collection and analysi
16. Phase 0 clinical trial
Phase 0 implicates investigative, first-in-
human (FIH) trials that are conducted
according to FDA guidelines.
Phase 0 trials termed as human micro
dose studies, they have single sub-
therapeutic doses given to 10 to 15
volunteers and give pharmacokinetic data
or help with imaging specific targets
without exerting pharmacological actions.
17. Phase 1: Safety and dosage
Phase I trials are the first tests of a drug with a lesser number of healthy
human volunteers.
clinical trials test a new biomedical intervention in a small group of people
(e.g., 20- 80) for the first time to evaluate safety (e.g., to determine a safe
dosage range, and to identify side effects).
Researchers adjust dosage regimen based on animal study data to find out
what dose of a drug can tolerate the body and what are its acute side
effects.
As a Phase 1 trial continues, researchers find out research mechanism of
action, the side effects with increase in dosage, and information about
effectiveness.
This is imperative to the design of Phase 2 studies.
Almost 70% of drugs travel to the next phase.
18. Phase 2: Efficacy and side effects
Phase II : clinical trials study the biomedical or behavioral
intervention in a larger group of people (several hundred) to
determine efficacy and to further evaluate its safety.
These trials aren‘t sufficient to confirm whether the drug will be
therapeutic.
Phase 2 studies provide with additional safety data to the
researchers.
Researchers use these data to refine research questions, develop
research methods, and design new Phase 3 research protocols.
Around 33% of drugs travel to the next phase.
Most prominently, Phase II clinical studies aid to found therapeutic
doses for the large-scale Phase III studies.
19. Phase 3: Efficacy and adverse drug reactions monitoring
Phase III studies investigate the efficacy of the biomedical or behavioral
intervention in large groups of human subjects (from several hundred to
several thousand) & monitor adverse effects.
Researchers plan Phase 3 studies to prove whether a product deals an
action benefit to a specific people or not.
These studies comprise 300 to 3,000 volunteers.
Phase 3 studies deliver most of the safety data.
The previous study might not able to detect less common side effects.
But phase 3 studies are conducted on large no. of volunteers and longer in
duration, the results are more probable to detect long-term or uncommon
side effects.
Around 25-30% of drugs travel to the next phase of clinical research.
If a drug developer has data from its previous tests, preclinical and clinical
trials that a drug is safe and effective for its intended use, then the industry
can file an application to market the medicine.
The FDA review team comprehensively inspects all submitted data on the
drug and makes a conclusion to approve or not to approve it
20. New Drug Application
A New Drug Application (NDA) expresses the full story of a drug
molecule.
Its purpose is to verify that a drug is safe and effective for its proposed use
in the people studied.
A drug developer must include all about a drug starting from preclinical
data to Phase 3 trial detain the NDA.
Developers must include reports on all studies, data, and analysis.
Beside with clinical trial outcomes, developers must include:
Proposed labeling
Safety updates
Drug abuse information
Patent information
21. FDA Review
Once FDA obtains a complete NDA then FDA team of review
may require about 6 to 10 months to take a pronouncement
on whether to approve the NDA.
If Once FDA obtains a incomplete NDA then FDA team of
review refuse the NDA.
If FDA governs that a drug has been revealed to be safe and
effective for its proposed use, it is then essential to work with
the developer for upgrade prescribing information. This is
denoted as ―labeling.
Labeling precisely defines the basis for approval and
direction how to use the drug.
Although, remaining issues required to be fixed before the
drug to be approved for marketing. In other cases, FDA have
need of additional studies.
At this situation, the developer can choose whether to
continue further development or not.
If a developer distresses with an FDA decision, there are
tools for official appeal.
22. Phase 4: Post-Market Drug Safety
Monitoring
Phase 4 trials are conducted when the drug or device has been approved by
FDA.
These trials are also recognized as post-marketing surveillance involving
pharmacovigilance and continuing technical support after approval.
There are numerous observational strategies and assessment patterns used
in Phase 4trials to evaluate the efficacy, cost-effectiveness, and safety of an
involvement in real-world settings.
Phase IV studies may be required by regulatory authorities (e.g. change in
labeling, risk management/minimization action plan) or may be undertaken
by the sponsoring company for competitive purposes or other reasons.
Therefore, the true illustration of a drug‘s safety essentially requires over
the months and even years that mark up a drug‘s lifespan in the market.
FDA reviews reports of complications with prescription and OTC drugs,
and can decide to add precautions to the dosage or practice information, as
well as other events for more serious adverse drug reactions.
23.
24.
25. Pharmacovigilance
Pharmacovigilance is defined as, "the science and activities relating
to the detection, assessment, understanding and prevention of
adverse effects or any other medicine-related problem".
The principal aims of pharmacovigilance programme are as
follows:
To improve patient care and safety in relation to the use of
medicines, and all medical and para-medical interventions.
To improve public health and safety in relation to the use of
medicines.
To contribute to the assessment of benefit, harm, effectiveness and
risk of medicines, encouraging their safe, rational and more effective
(including cost effective) use.
To promote understanding, education and clinical training in
pharmacovigilance and its effective communication to health
professionals and the public.
26. Several stake holders are involved
in monitoring safety of medicines.
Some of them are listed below:
• Government
• Pharmaceutical industries
• Hospitals and academia
• Medical and pharmaceutical associations
• Poisons and medicines information centers
• Health professionals like doctors, pharmacists, nurses
• Patients
• Consumers
• The media
• World Health Organization (WHO)
27. Pharmacovigilance in India
The scope and objectives of the Pharmacovigilance are
indicated below:
To create a nation-wide system for patient safety reporting.
To identify and analyze new signals from the reported cases.
To analyze the benefit-risk ratio of marketed medications.
To generate evidence-based information on safety of medicines.
To support regulatory agencies in the decision-making process on use of
medications.
To communicate the safety information on use of medicines to various
stake holders to minimize the risk.
To emerge as a national center of excellence for pharmacovigilance
activities.
To collaborate with other national centers for the exchange of information
and data management.
To provide training and consultancy support to other national
pharmacovigilance centers across globe.
To identify and analyze new ADR signal from the reported cases.
To promote rational use of medicines.