Pharmacovigilance involves monitoring the effects of medications after they have been approved for use in order to detect adverse effects. It became an important field after the thalidomide disaster in the 1960s, which caused birth defects. The goals of pharmacovigilance are to improve patient safety, contribute to assessing medication risks and benefits, and promote safe medication use. It involves collecting, analyzing, and communicating information on adverse drug reactions from healthcare providers and manufacturers. The World Health Organization plays a key role in coordinating international pharmacovigilance efforts through the Uppsala Monitoring Centre.
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
This ppt is about pharmacovigilance in India & spontaneous reporting of adverse drug effect and there regulation by WHO or uppsala. It also include drug interaction in herbal medicine.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time.
Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period.
Geneva Pharma Forum on Pharmacovigilance: Partnering for
Patient Safety (Geneva, 20 November 2012), Jeremiah Mwangi, Director, Policy and External Affairs, IAPO
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
This ppt is about pharmacovigilance in India & spontaneous reporting of adverse drug effect and there regulation by WHO or uppsala. It also include drug interaction in herbal medicine.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time.
Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period.
Geneva Pharma Forum on Pharmacovigilance: Partnering for
Patient Safety (Geneva, 20 November 2012), Jeremiah Mwangi, Director, Policy and External Affairs, IAPO
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Pharmacovigilance & WHO Drug Monitoring Program.pptxEasy Concept
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
The Pharmacovigilance Programme of India is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems.
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
عرض تقديمي دعائي عصري أبيض وأرجواني.pptxOmarAlqadi5
Types of water in pharmaceutical preparation and sources including purified water, distilled water,water for injection, water for irrigation, bacteriostatic water, potable water , drinking water, deionization,pyrogen test
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Pharmacovigilance & WHO Drug Monitoring Program.pptxEasy Concept
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
The Pharmacovigilance Programme of India is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems.
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
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Types of water in pharmaceutical preparation and sources including purified water, distilled water,water for injection, water for irrigation, bacteriostatic water, potable water , drinking water, deionization,pyrogen test
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The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
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http://sandymillin.wordpress.com/iateflwebinar2024
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2024.06.01 Introducing a competency framework for languag learning materials ...
pharmacovigilance.pptx
1.
2. What is Pharmacovigilance ?
• Pharmakon (Greek) = Medicinal Substances
• Vigilia (Latin) = To keep watch
• WHO Definition
– The science & activities relating to the detection,
assessment, understanding & prevention of
adverse effects or any other drug related
problems
6. Historical Background Thalidomide
• 1960 marketed in 46 countries (hypnotic,
prevention of nausea in pregnancy)
• Heavily promoted
• 1960 first reports of deformed infants
(phoecomelia) total more than 20,000 cases
7. Direct result of thalidomide incident:
• USA: 1962 amendment to Federal Food, drug
& Cosmetic Act - required both safety &
efficacy data
• UK: 1964 Yellow card scheme
• WHO: 1968 Programme for International Drug
Monitoring
8. Aims
• To improve patient care and safety in relation
to the use of medicines, and all medical and
paramedical interventions
• To improve public health and safety in relation
to the use of medicines
9. To contribute
• to the assessment of benefit, harm,
effectiveness and risk of medicines,
encouraging their safe, rational and more
effective use
• To promote understanding, education and
clinical training in pharmacovigilance and its
effective communication to health
professionals and the public
10. Terminology
• Adverse Drug Reaction (ADR)
• An unintended reaction to a drug taken at
doses normally used in man When an
association between an AE and a drug is
established it becomes an ADR
11. • Adverse Event (AE) – A negative experience
encountered by an individual during the
course of a clinical trail, which may or may not
be associated with a drug
• Serious Adverse Event (SAE) – Any adverse
event which is fatal, life- threatening,
permanently disabling or which results in
hospitalilsation
12. Pharmacovigilance Process
• Detecting and reporting an ADR ADR form is
filled out with the patient and reaction details,
this later forms basis for data entry
1. Spontaneous reporting
2. Mandatory reporting
13. Spontaneous reporting
• Most common form of ADR reporting
• Healthcare professionals identify and report
any suspected adverse drug reaction to their
national pharmacovigilance centers or to the
manufactuters
14. Mandatory reporting
• Manufacturers are required to submit reports to they
receive from healthcare providers to the national
authority, in the form of a PSUR (Periodic Safety
Update Report)
• A regulatory document prepared by the Marketing
Authorisation Holder & submitted to the Agency
• Worldwide post-authorisation safety experience
• Includes information on all ADRs collected irrespective
of the reporting country
• Includes scientific evaluation of the risk-benefit
balance
15. • Data Collection and Capture
• Data Storage & Maintenance
• Data selection, Retrieval & Manipulation
16. Signal Detection
• Signal: New, previously unknown safety
information
WHO Definition
• Reported information on a possible causal
association between an Adverse Event and a
drug, the relationship being unclear or
incompletely documented previously
17. Regulatory actions on
• the basis of ADR reports
• Summary of Product Characteristics (SPC) –
basis of information for Healthcare
Professionals on how to use the medicinal
product safely and effectively
• Patient Information Leaflets (PIL) – drawn up
in accordance with the SPC
18. • • Changes in classification: – From Over the
counter to Prescription only Medicine – From
renewable prescription to non-renewable –
Special medical prescription – Restricted
prescription • Marketing Authorization
withdrawal • Batch recall based on clustering
of ADRs
19. • WHO & UMC
• Uppsala Monitoring Centre (UMC) is a field
name of the WHO collaborating Centre for
International Drug Monitoring.
• It is responsible for the management of the
WHO program for International Drug
Monitoring.
20. Functions of WHO
• Program for international drug monitoring include:
• Identification and analysis of new adverse reaction
signal from the case report information submitted to
the National Centers and from them to the database
• Information exchange between WHO and National
Centers, mainly through ‘Vigimed’ an e-mail
information exchange system
• Publication of periodical newsletters, guidelines and
books in the pharmacovigilance and risk management
area
21. Supply of
• tools for management of clinical information
including adverse drug reaction case reports –
WHO Drug Dictionary – WHO Adverse Reaction
Terminology
• Provision of training and consultancy support to
National Centers and countries establishing
pharmacovigilance systems
• Computer software for case report management
designed to suit the needs of National Centers
(Vigiflow)
22. Annual meetings
• for representatives of National Centers at
which Scientific and Organizational matters
are discussed
• Methodological research for the development
of pharmacovigilance as a science
23. Functions of UMC
• To co-ordinate the WHO program for
international drug monitoring and its more than
eighty member countries
• To collect, assess and communicate information
from member countries about the benefits,
harms and risks of drugs and other substances
used in medicine to improve patient therapy and
public health worldwide
• To collaborate with member countries in the
development and practice of the science of
pharmacovigilance
24. Goal
• To ensure that the benefits of use of medicine
outweighs the risks and thus safeguard the
health of the Indian population.
25. Objectives
• To monitor Adverse Drug Reactions (ADRs) in Indian
population
• To create awareness amongst health care professionals
about the importance of ADR reporting
• To monitor benefit-risk profile of medicines
• Generate independent, evidence based recommendations
on the safety of medicines
• Support the CDSCO for formulating safety related
regulatory decisions for medicines
• Communicate findings with all key stakeholders
• Create a national centre of excellence at par with global
drug safety monitoring standards