Vaccine safety Surveillance
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Regulatory terminology of ADR and Establishing pharmacovigilance center's i...
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
Spontaneous Reporting System
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) data assessment of individual cases and pooled data, and 3) data interpretation to generate safety signals. Countries have different reporting forms, like the Yellow Card used in the UK since 1964. Factors like educational campaigns and inclusion of reporting options in prescription pads have helped increase reporting rates in the UK. India's Pharmacovigilance Programme similarly encourages voluntary reporting of all suspected adverse reactions via established adverse drug monitoring centers.
INTERNATIONAL NON PROPRIETARY NAMES FOR DRUGS1.pptx
International Nonproprietary Names (INNs) provide a unique name for each pharmaceutical substance to aid clear identification and safe use worldwide. The WHO manages the INN system, selecting names through a process involving proposed names, an objection period, and final recommended INNs. INNs aim to identify substances uniquely while avoiding names that could cause confusion or be proprietary. Principles for selection include being distinctive, concise, and avoiding confusion with other names. Stem elements are often used to group related substances.
Methods and Tools for ADR Reporting.pptx
This document discusses methods and tools for adverse drug reaction (ADR) reporting. It defines ADR reporting and its importance. Anyone can report ADRs by filling out a standard form available online or offline and submitting it to their nearest monitoring center. Common tools for ADR reporting include Argus Oracle and Aris G software used by drug manufacturers, and Vigiflow and Vigibase databases maintained by the WHO. Healthcare professionals and consumers can report any suspected ADRs using spontaneous reporting or other methods to national pharmacovigilance centers.
Adverse drug reactions
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Spontaneous reporting
Spontaneous reporting involves unsolicited communication about suspected adverse drug reactions (ADRs) to regulatory authorities from healthcare professionals or consumers. Passive surveillance relies on voluntary ADR reporting by health professionals, while active surveillance uses organized monitoring systems. The Pharmacovigilance Programme of India (PvPI) currently uses spontaneous reporting to collect drug safety data. Reporting forms collect patient information, reaction details, suspected medications, and reporter information to submit individual case safety reports (ICSRs) on suspected ADRs. Both healthcare professionals and consumers can report ADRs to the National Coordination Centre (NCC) to help ensure public health and drug safety.
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
ADR reporting Tools Used In Clinical research and Pharmacovigilance
1 Vigiflow
2 Argus-G
3 Aris
History and progress of pharmacovigilance
About the history and progression of pharmacovigilance (monitoring of ADR's in phase 4 clinical trials/ post markrting surveillance )
Recommended
Regulatory terminology of ADR and Establishing pharmacovigilance center's i...
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
Spontaneous Reporting System
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) data assessment of individual cases and pooled data, and 3) data interpretation to generate safety signals. Countries have different reporting forms, like the Yellow Card used in the UK since 1964. Factors like educational campaigns and inclusion of reporting options in prescription pads have helped increase reporting rates in the UK. India's Pharmacovigilance Programme similarly encourages voluntary reporting of all suspected adverse reactions via established adverse drug monitoring centers.
INTERNATIONAL NON PROPRIETARY NAMES FOR DRUGS1.pptx
International Nonproprietary Names (INNs) provide a unique name for each pharmaceutical substance to aid clear identification and safe use worldwide. The WHO manages the INN system, selecting names through a process involving proposed names, an objection period, and final recommended INNs. INNs aim to identify substances uniquely while avoiding names that could cause confusion or be proprietary. Principles for selection include being distinctive, concise, and avoiding confusion with other names. Stem elements are often used to group related substances.
Methods and Tools for ADR Reporting.pptx
This document discusses methods and tools for adverse drug reaction (ADR) reporting. It defines ADR reporting and its importance. Anyone can report ADRs by filling out a standard form available online or offline and submitting it to their nearest monitoring center. Common tools for ADR reporting include Argus Oracle and Aris G software used by drug manufacturers, and Vigiflow and Vigibase databases maintained by the WHO. Healthcare professionals and consumers can report any suspected ADRs using spontaneous reporting or other methods to national pharmacovigilance centers.
Adverse drug reactions
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Spontaneous reporting
Spontaneous reporting involves unsolicited communication about suspected adverse drug reactions (ADRs) to regulatory authorities from healthcare professionals or consumers. Passive surveillance relies on voluntary ADR reporting by health professionals, while active surveillance uses organized monitoring systems. The Pharmacovigilance Programme of India (PvPI) currently uses spontaneous reporting to collect drug safety data. Reporting forms collect patient information, reaction details, suspected medications, and reporter information to submit individual case safety reports (ICSRs) on suspected ADRs. Both healthcare professionals and consumers can report ADRs to the National Coordination Centre (NCC) to help ensure public health and drug safety.
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
ADR reporting Tools Used In Clinical research and Pharmacovigilance
1 Vigiflow
2 Argus-G
3 Aris
History and progress of pharmacovigilance
About the history and progression of pharmacovigilance (monitoring of ADR's in phase 4 clinical trials/ post markrting surveillance )
Pharmacovigilance & Adverse drug reaction
This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
Establishment of Pharmacovigilance Programme
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
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTION
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
Detection and Reporting of Adverse Reaction
This document discusses pharmacovigilance and adverse drug reaction reporting. It covers several topics: methods of detecting ADRs like pre-marketing safety evaluation, post-marketing surveillance, and causality assessment; communicating ADR information to health professionals; and methods for reporting ADRs like spontaneous reporting and standardized case report forms. The key aspects of ADR reporting include who should report, what to report, and where to send reports for evaluation. Accurate documentation of patient information, suspected drugs, and reactions is important for assessment.
Methods in causality assessment.pptx
Chetan G. Kumbhar's topic discusses methods for assessing causality between drug treatments and adverse reactions or events. There are three main categories of causality assessment methods: 1) expert judgment, which relies on an expert's experience and knowledge; 2) algorithms, which use standardized tools like the Naranjo scale to calculate the likelihood of causation; and 3) probabilistic methods, which use Bayesian statistics to transform prior probabilities into posterior probabilities of drug causation based on epidemiological data and evidence from a particular case. The goal of causality assessment is to determine relationships between drugs and adverse events, detect new safety signals, better understand drug toxicities and benefits, and evaluate adverse drug reaction reports.
Pharmacovigilance methods
Active Surveillance, Passive Surveillance, Comparative observational methods, stimulated reporting, targeted clinical investigations
Pharmacovigilance program of India (PvPI)
This document provides an overview of pharmacovigilance in India, including:
- The history of pharmacovigilance efforts in India from 1986 to the present.
- The objectives and goals of the current Pharmacovigilance Program of India (PvPI), including establishing a nationwide safety reporting system and expanding electronic reporting.
- The roles and responsibilities of stakeholders like the National Coordinating Center, Advisory Monitoring Centers, and CDSCO in the PvPI.
Establishing Pharmacovigilance Centres In Hospital.pptx
The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
Ind enabling studies.
This document discusses the requirements for an investigational new drug (IND) application. An IND is required to initiate clinical trials of an unapproved drug and must contain information on animal studies, manufacturing, and clinical trial protocols. The core battery of safety pharmacology studies evaluates effects on major organ systems like the cardiovascular, central nervous, and respiratory systems. These studies are designed to identify potential adverse effects and safety risks before human clinical trials.
statistical analysis by apurva.pdf
Introduction
•All medicinal products carry risks in addition to their possible benefits for developing a new medicine, a decision can only be made if both benefits & risks are addressed. Risk associated with the drug is minimized when medicines of good quality, safety & efficacy are used rationally by an informed health professional & by patients. Pharmacovigilance helps in reducing the risk of harm by ensuring use of good quality medicines appropriately. Need of international efforts to address drug safety were realized &
initiated in 1961, following the Thalidomide disaster. Guidelines were developed to monitor drugs, foods & environmental contaminants for adverse reactions & toxicity . In beginning, guidelines were restricted to local needs. Globalization -
recognized need of a system, accepted internationally, to ensure safety
of medicinal products.New drugs: marketed on basis of comparatively limited information, as clinical trials are designed to answer specific questions .•In US, ~ 500 to 2000 patients receive a new drug during clinical trials, & only a few hundred of them are treated > 3-6 months
• In clinical trials, critical efficacy endpoints are identified in advance
& sample sizes are estimated for assessment of effectiveness .
• Common AEs are generally identified & well characterized in
prospective trials
•Infrequent or delayed AE Characteristic depending on their severity
and importance to risk benefits and require special techniques
•Isolated report- definitive in associating a drug with an AE, if drug
administration and event are temporally related, de- challenging or
re-challenging.
•In contrast with few exceptions phase 2 3 trial are not designed to
test specified hypothesis about safety nor to measure identifying AE
with any specified hypotheses about safety nor to measure or identify
AEs with any pre-specified level of sensitivity.
• Exceptions occur when a particular concern related to drug or drug
class has arisen & when there is a specific safety advantage being
studied.
• Safety evaluation during clinical drug development is not expected to
characterize all the AEs, for example, those occurring in < 1 in 1000
patients
•Risks that may be missed include
• rare events
• events occurring after long-term use
• events occurring in special populations
• events occurring in association with specific diseases &
• events occurring in association with concomitant therapy Introduction
STATISTICAL METHODS FOR PHARMACOVIGILANCE
A VERY SIMPLIFIED VERSION OF STATISTICAL METHODS FOR PHARMACOVIGILANCE
Prepared for M.Pharm Pharmacology- Clinical Research and Pharmacovigilance
Guidelines on adr reporting
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
ICSR (individual case safety report)
The document discusses individual case safety reports (ICSRs) and the process for reporting adverse drug reactions (ADRs). An ICSR contains identifiable information about the reporter, patient, suspected adverse event, and suspected medicinal product. The steps for reporting include ICSR collection, processing, data entry, quality review, and medical review. Key requirements are that an ICSR contains identifiable information on the reporter, patient, suspected ADR, and suspected product to allow for reporting of ADRs occurring in single patients.
Spontaneous reporting
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) assessment of individual reports and pooled data, and 3) interpretation of signals based on the available data. Initiatives have been taken to widen reporting bases to include pharmacists and nurses. Special focus has been given to reporting reactions related to HIV drugs, pediatric drugs, and herbal products to improve surveillance in underreported areas.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
Clinical trial study team
Explaining Roles and responsibilities of clinical trial personnel :Investigator,study coordinator,sponsor,CRO.
Regulatory terminologies used in PV (Pharmacovigilance)
This document defines various regulatory terminologies used in pharmacovigilance (PV). It defines key terms like pharmacovigilance, adverse drug reactions, clinical trials, causality assessment, and data mining. It also provides definitions for terms related to evaluating drug safety like absolute risk, incidence, benefits, harms, and effectiveness/risk analysis. Regulatory organizations involved in PV like CIOMS, ICH, and MedDRA are also defined.
Severity, seriousness, predictability and preventability assessment
This document discusses the assessment of severity and seriousness of adverse drug reactions (ADRs). It defines severity as the intensity of a medical event, categorizing ADRs as mild, moderate or severe based on management steps. It also describes several classification scales for ADR severity, including one by Karch and Lasagna and the Modified Hartwig's and Siegel Scale. The document defines seriousness classification according to regulatory criteria. It then discusses preventability and predictability of ADRs, describing scales by Schumock and Thornton for preventability and the distinction between Type A and Type B reactions in terms of predictability.
Vaccine safety surveillance
This document discusses vaccine safety surveillance systems. It describes post-marketing surveillance systems like VAERS in the US and EudraVigilance in Europe that monitor adverse events. International organizations like WHO and programs like EPI work to strengthen safety surveillance globally and help low-income countries monitor vaccines. Harmonized reporting systems, guidelines, and data sharing aim to ensure vaccine safety worldwide.
WHO International Drug Monitoring Program
The WHO International Drug Monitoring Program was established in 1963 in response to the thalidomide disaster. It currently has 143 member countries that submit adverse drug reaction reports to the global pharmacovigilance database VigiBase managed by the Uppsala Monitoring Centre (UMC) as a WHO collaborating center. The UMC analyzes VigiBase data to identify new safety signals, conducts research, and provides tools and training to support member countries' pharmacovigilance activities. The overall goals are to identify unknown adverse drug reactions and ensure medicines are used safely worldwide.
tabletprocessingproblemsandtheirremedies-150209220608-conversion-gate01.pdf
tabletprocessingproblemsandtheirremedies-150209220608-conversion-gate01.pdfDr. Yuppie Rajasekhar Poonuru
This document discusses common tablet processing problems and their remedies. It begins by introducing tablets and defining defects related to machine, formulation, and tableting process factors. Specific defects covered include capping, lamination, cracking, chipping, sticking, picking, binding, double impression, and mottling. Potential causes and remedies are provided for each defect from both formulation and machine-related perspectives. Problems and remedies associated with tablet coating are also reviewed, such as blistering, cratering, picking and sticking, pitting, blooming, color variation, orange peel effect, bridging, and cracking or splitting. The document provides a comprehensive overview of tablet defects and potential solutions.More Related Content
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Pharmacovigilance & Adverse drug reaction
This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
Establishment of Pharmacovigilance Programme
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
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTION
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
Detection and Reporting of Adverse Reaction
This document discusses pharmacovigilance and adverse drug reaction reporting. It covers several topics: methods of detecting ADRs like pre-marketing safety evaluation, post-marketing surveillance, and causality assessment; communicating ADR information to health professionals; and methods for reporting ADRs like spontaneous reporting and standardized case report forms. The key aspects of ADR reporting include who should report, what to report, and where to send reports for evaluation. Accurate documentation of patient information, suspected drugs, and reactions is important for assessment.
Methods in causality assessment.pptx
Chetan G. Kumbhar's topic discusses methods for assessing causality between drug treatments and adverse reactions or events. There are three main categories of causality assessment methods: 1) expert judgment, which relies on an expert's experience and knowledge; 2) algorithms, which use standardized tools like the Naranjo scale to calculate the likelihood of causation; and 3) probabilistic methods, which use Bayesian statistics to transform prior probabilities into posterior probabilities of drug causation based on epidemiological data and evidence from a particular case. The goal of causality assessment is to determine relationships between drugs and adverse events, detect new safety signals, better understand drug toxicities and benefits, and evaluate adverse drug reaction reports.
Pharmacovigilance methods
Active Surveillance, Passive Surveillance, Comparative observational methods, stimulated reporting, targeted clinical investigations
Pharmacovigilance program of India (PvPI)
This document provides an overview of pharmacovigilance in India, including:
- The history of pharmacovigilance efforts in India from 1986 to the present.
- The objectives and goals of the current Pharmacovigilance Program of India (PvPI), including establishing a nationwide safety reporting system and expanding electronic reporting.
- The roles and responsibilities of stakeholders like the National Coordinating Center, Advisory Monitoring Centers, and CDSCO in the PvPI.
Establishing Pharmacovigilance Centres In Hospital.pptx
The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
Ind enabling studies.
This document discusses the requirements for an investigational new drug (IND) application. An IND is required to initiate clinical trials of an unapproved drug and must contain information on animal studies, manufacturing, and clinical trial protocols. The core battery of safety pharmacology studies evaluates effects on major organ systems like the cardiovascular, central nervous, and respiratory systems. These studies are designed to identify potential adverse effects and safety risks before human clinical trials.
statistical analysis by apurva.pdf
Introduction
•All medicinal products carry risks in addition to their possible benefits for developing a new medicine, a decision can only be made if both benefits & risks are addressed. Risk associated with the drug is minimized when medicines of good quality, safety & efficacy are used rationally by an informed health professional & by patients. Pharmacovigilance helps in reducing the risk of harm by ensuring use of good quality medicines appropriately. Need of international efforts to address drug safety were realized &
initiated in 1961, following the Thalidomide disaster. Guidelines were developed to monitor drugs, foods & environmental contaminants for adverse reactions & toxicity . In beginning, guidelines were restricted to local needs. Globalization -
recognized need of a system, accepted internationally, to ensure safety
of medicinal products.New drugs: marketed on basis of comparatively limited information, as clinical trials are designed to answer specific questions .•In US, ~ 500 to 2000 patients receive a new drug during clinical trials, & only a few hundred of them are treated > 3-6 months
• In clinical trials, critical efficacy endpoints are identified in advance
& sample sizes are estimated for assessment of effectiveness .
• Common AEs are generally identified & well characterized in
prospective trials
•Infrequent or delayed AE Characteristic depending on their severity
and importance to risk benefits and require special techniques
•Isolated report- definitive in associating a drug with an AE, if drug
administration and event are temporally related, de- challenging or
re-challenging.
•In contrast with few exceptions phase 2 3 trial are not designed to
test specified hypothesis about safety nor to measure identifying AE
with any specified hypotheses about safety nor to measure or identify
AEs with any pre-specified level of sensitivity.
• Exceptions occur when a particular concern related to drug or drug
class has arisen & when there is a specific safety advantage being
studied.
• Safety evaluation during clinical drug development is not expected to
characterize all the AEs, for example, those occurring in < 1 in 1000
patients
•Risks that may be missed include
• rare events
• events occurring after long-term use
• events occurring in special populations
• events occurring in association with specific diseases &
• events occurring in association with concomitant therapy Introduction
STATISTICAL METHODS FOR PHARMACOVIGILANCE
A VERY SIMPLIFIED VERSION OF STATISTICAL METHODS FOR PHARMACOVIGILANCE
Prepared for M.Pharm Pharmacology- Clinical Research and Pharmacovigilance
Guidelines on adr reporting
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
ICSR (individual case safety report)
The document discusses individual case safety reports (ICSRs) and the process for reporting adverse drug reactions (ADRs). An ICSR contains identifiable information about the reporter, patient, suspected adverse event, and suspected medicinal product. The steps for reporting include ICSR collection, processing, data entry, quality review, and medical review. Key requirements are that an ICSR contains identifiable information on the reporter, patient, suspected ADR, and suspected product to allow for reporting of ADRs occurring in single patients.
Spontaneous reporting
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) assessment of individual reports and pooled data, and 3) interpretation of signals based on the available data. Initiatives have been taken to widen reporting bases to include pharmacists and nurses. Special focus has been given to reporting reactions related to HIV drugs, pediatric drugs, and herbal products to improve surveillance in underreported areas.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
Clinical trial study team
Explaining Roles and responsibilities of clinical trial personnel :Investigator,study coordinator,sponsor,CRO.
Regulatory terminologies used in PV (Pharmacovigilance)
This document defines various regulatory terminologies used in pharmacovigilance (PV). It defines key terms like pharmacovigilance, adverse drug reactions, clinical trials, causality assessment, and data mining. It also provides definitions for terms related to evaluating drug safety like absolute risk, incidence, benefits, harms, and effectiveness/risk analysis. Regulatory organizations involved in PV like CIOMS, ICH, and MedDRA are also defined.
Severity, seriousness, predictability and preventability assessment
This document discusses the assessment of severity and seriousness of adverse drug reactions (ADRs). It defines severity as the intensity of a medical event, categorizing ADRs as mild, moderate or severe based on management steps. It also describes several classification scales for ADR severity, including one by Karch and Lasagna and the Modified Hartwig's and Siegel Scale. The document defines seriousness classification according to regulatory criteria. It then discusses preventability and predictability of ADRs, describing scales by Schumock and Thornton for preventability and the distinction between Type A and Type B reactions in terms of predictability.
Vaccine safety surveillance
This document discusses vaccine safety surveillance systems. It describes post-marketing surveillance systems like VAERS in the US and EudraVigilance in Europe that monitor adverse events. International organizations like WHO and programs like EPI work to strengthen safety surveillance globally and help low-income countries monitor vaccines. Harmonized reporting systems, guidelines, and data sharing aim to ensure vaccine safety worldwide.
WHO International Drug Monitoring Program
The WHO International Drug Monitoring Program was established in 1963 in response to the thalidomide disaster. It currently has 143 member countries that submit adverse drug reaction reports to the global pharmacovigilance database VigiBase managed by the Uppsala Monitoring Centre (UMC) as a WHO collaborating center. The UMC analyzes VigiBase data to identify new safety signals, conducts research, and provides tools and training to support member countries' pharmacovigilance activities. The overall goals are to identify unknown adverse drug reactions and ensure medicines are used safely worldwide.
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ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTION
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Establishing Pharmacovigilance Centres In Hospital.pptx
Establishing Pharmacovigilance Centres In Hospital.pptx
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Regulatory terminologies used in PV (Pharmacovigilance)
Regulatory terminologies used in PV (Pharmacovigilance)
Severity, seriousness, predictability and preventability assessment
Severity, seriousness, predictability and preventability assessment
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Griseofulvin nanostructured lipid carriers (G-NLCs) were developed for the topical treatment of tinea pedis (athlete's foot fungus). A microemulsion method was used to prepare the G-NLCs using glyceryl monostearate, stearic acid and pluronic F68. The particles were optimized using a box-behnken design and incorporated into a carbopol gel. In vivo studies on rats showed the G-NLC gel was more effective at reducing fungal infection than the marketed antifungal cream based on histopathology and reduced oxidative stress markers. Cytotoxicity studies of the nanogel on skin cells demonstrated good biocompatibility
drugs and disease
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Non compartmental modelling
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Bioavailability refers to the amount of drug that enters systemic circulation after administration. It is impacted by absorption and first-pass metabolism. Bioequivalence compares the rates and extents of drug absorption between products to determine if they can be expected to have similar effects. Key parameters assessed in bioequivalence studies include Cmax, Tmax, and AUC which are obtained from plasma concentration-time profiles following drug administration. Urinary excretion studies can also be used to assess bioequivalence. The goal is to show that test and reference products have similar pharmacokinetic properties.
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Recomendamos muito.
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