The pharma aspirants can read the important information provided in this presentation about Pharmacovigilance which is necessary to qualify the interviews of the same field
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Definition and scope of Pharmacoepidemiology ABUBAKRANSARI2
In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.
Epidemiology is the study of occurrence, distribution and determinants of health and
diseases or disorders in man and its application in controlling health problems.
Epidemiology has by tradition two major areas.
First is the study of infectious diseases that spread to large populations, i.e., epidemics.
The second is the study of chronic diseases.
Epidemiological studies help to solve such health problems and provide a basis for
improving living conditions of the people.
During its progress and development, epidemiology has made available precise and
strict methodologies for the study of diseases.
Pharmacology is the study of the effects of drugs.
Clinical Pharmacology is the study of the effects of drugs in humans, It is traditionally
divided into two basic areas namely:
1. Pharmacokinetics
2. Pharmacodynamics.
Pharmacokinetics is the study of the relationship between dose administered of a drug
and the serum or blood level achieved, it deals with absorption, distribution, metabolism
and excretion.
Epidemiology is the study of the distribution and determinants of diseases in
populations.
Epidemics is the study of chronic/ infectious diseases in large populations.
Pharmacoepidemiology is the study of the use of and the effects of drugs in large
number of people.
It involves the examination of a single individual or large groups of people followed for
many years.
It involves gathering & analysis of information in order to identify possible causation &
related factors, that can be applied in clinical practice to group of people & also to
individuals undergoing treatment.
Post Marketing Surveillance (Regulatory affairs).pptxYuvaraj KG
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time.
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
The Impact of Artificial Intelligence on Modern Society.pdfssuser3e63fc
Just a game Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?Assignment 3
1. What has made Louis Vuitton's business model successful in the Japanese luxury market?
2. What are the opportunities and challenges for Louis Vuitton in Japan?
3. What are the specifics of the Japanese fashion luxury market?
4. How did Louis Vuitton enter into the Japanese market originally? What were the other entry strategies it adopted later to strengthen its presence?
5. Will Louis Vuitton have any new challenges arise due to the global financial crisis? How does it overcome the new challenges?
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2. INTRODUCTION TO PHARMACOVIGILANCE
Pharamcovigilance is the science and activities relating to the detection, assessment,
understanding and prevention of adverse effect.
Aims Of Pharmacovigilance
1. To improve patient care and safety
2. To improve public health and safety.
3. To contribute to the assessment, harm, effectiveness and risk of medicines.
4. To promote education and clinical trails.
5. To promote rational and safe use of medicines.
3. METHODS OF PHARMACOVIFILANCE
Passive surveillance
1. Spontaneous reporting
2. Stimulated reporting
3. Intensified reporting
4. Targeted spontaneous reporting
Active surveillance
Comparative observational studies
Clinical studies
OBJECTIVES
1. To established a functional reporting system to monitor the safety of all medicines.
2. To learn more about the safety profile of new medicines in early post marketing
phase.
3. To learn more about the ADR profile of a specific medicines in your population.
4. PASSIVE SURVILLANCE
1. Spontaneous reporting
A functional ADR system to monitor the safety of all medicines
Reports are submitted voluntarily by health care professionals, pharmaceutical
companies or patients to the pharmacovigilance centre
Reporting systems are based on suspected ADRs
Data are collected in a central or regional data base
Reporting form contains- reporter details, patient details, suspected product details
and the description of suspected reaction
This reporting is based on suspected adverse drug reactions
Cases are not collected systematically
These methods includes calculations of a proportional reporting ratio, as well as the
use of Bayesian and other techniques for signal detection.
Data techniques should always be used to examine drug drug interactions
5. 2.Stimulated reporting
A method used to encouraged and facilitate reporting by health professionals for new
products or for limited time period.
Methods- on line reporting of AE, systematic stimulation of reporting of AE.
Stimulated adverse event reporting in the early post-marketing phase can lead
companies to notify healthcare professionals of new therapies and provide safety in
the use by the general population.
Data are often incomplete.
Not useful to generate accurate incidence rates.
6. 3.Intensified reporting
This is an extension of spontaneous reporting program
It aims to enhance ADR reporting of specific medicines in early post marketing phase
The procedure is usually followed for new drugs, biological medicines and for medicines that
require additional studies
Example: Antiretroviral medicines under a separate program
4.Targeted spontaneous reporting
This method is used to learn more about ADR profile of a specific medicine in the population
To estimate the incidences of a known ADR for a specific medicine in a population
Example: Monitoring renal toxicities related to the use of tenofovir based regimen in antiretroviral
therapy
7. Active Surveillance
Sentinal sites: It involves the collection of AE data from only part of the total population
to learn something about the larger population.
Example: to study the trends in a disease.
Drug event monitoring: The patients are identified from electronic prescription data or
automated health insurance claims. Patients will fill the survey form. Follow up
questionnaire is then sent to prescribing physician.
Registries: A registry is a list of patients with the same characteristics. The registries
may be disease specific (disease registry) or drug specific (drug registry) or type of
exposure during a specific life event (pregnancy exposure registry). The information is
collected using standardized questionaries.
8. Comparative observational studies
Cross sectional study: The data collected from a population of patients can be attributed at a
single point of time/time interval regardless of exposure or disease status.
Case control study: Cases/patients of AEs are identified from an existing data baseor using data
collected specifically for the purpose of the study.
Cohort studies.
I. Cohort means a group of people who share a common characteristic such as exposure to a drug
within a defined time period.
II. It is a prospective observational cohort study of adverse events associated with one or more
medicines.
III. The study is planned prior to beginning of the treatment with the medication.
IV. Every patient is followed up for adverse events since the time of treatment.
V. All adverse events are recorded.
9. Cross-sectional study
Data collected on a population of patient at a single point in time regardless of exposure or disease status
constitute a cross secyional study.
These type of study primarily used gather data for survey.
These studies re best used to examine disease at one time point or to examine trends over time.
These are best utilized when exposure do not change over time.
Case control study
I. In this study,case of disease are identified.
II. Case control studies are particularly useful when the goal is to investigate whether there is an association
between a drug and one specific rare adverse event as well as to identify risk factors for adverse events.
III. Risk factors includes conditions such as renal and hepatic dysfunction.
10. Clinical studies
When significant risk are identified from pre approval clinical trials further clinical studies
might be called for evaluate the mechanism of action for the adverse reaction
In some instances pharmacodynamic and pharmacokinetic studies might be conducted to
determine whether a particular dosing instruction can put patient at an increased risk of
adverse event based on the pharmacological properties and expected use of drug in
general practice conducting specific studies to investigate potential drug drug interaction
and food drug interaction might be called for.
These studies can include population pharmacokinetics studies and drug concentration
monitoring in patient and normal volunteers these population might include the elderly or
children of patient with renal or hepatic disorder.
11. Descriptive studies
These studies are primarily used to obtain the background rate of outcome event or establish the prevalence
of the use of drug in specified population and it is not used for the detection or verification of adverse event
I. Natural history of disease
the science of epidemiology originally focused on the natural history of disease including the characteristics
of disease patient and the distribution of disease in selected population
these outcomes of interest now include a description of disease treatment pattern and adverse event
studies that examine specific aspect of adverse event such as background incidence rate of risk factor for the
advance event of interest can be used to assist in putting spontaneous reports into perspective
Drug utilisation study
This study describes how a drug is marketed prescribed and used in a population and how these factors
influence outcomes including clinical social and economic studies
from these studies denominator data can be developed for use in determining rates of adverse event reactions