FDA guidance for post marketing study commitments - Pharmaceuticals
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Signifcance of pharmacovigilance & risk management planAnsuman Parida
Pharmacovigilance is concerned with monitoring the safety of pharmaceutical drugs. It involves collecting, detecting, and assessing adverse drug reactions and preventing harm to patients. A risk management plan describes the known safety risks of a drug and outlines activities to further characterize risks, minimize risks to patients, and evaluate the effectiveness of risk minimization measures. Key parties in a risk management plan include patients, healthcare professionals, regulators, payers, pharmaceutical companies, and politicians. Risk management plans help ensure medications are reasonably safe and effective for their intended uses.
The document discusses pharmacovigilance, which involves monitoring the safety of medical products. It outlines various methods for collecting and analyzing adverse event reports, including spontaneous reports from healthcare professionals and patients, literature reviews, and solicited reports from clinical trials. It also discusses prioritizing cases, signal detection methods, and actions that may be taken in response to potential safety issues. The main objectives are to minimize risks for patients and the company while meeting regulatory requirements.
This document discusses post-marketing surveillance (PMS), which involves monitoring drugs after they reach the market to detect previously unrecognized effects. PMS is important for safety and improving products. Key goals are identifying adverse effects and characterizing incidence rates. Several methods are used in PMS, including voluntary reporting, controlled trials, cohort studies, and case-control studies. Cohort studies follow groups over time to assess outcomes, while case-control studies compare exposure rates between those with and without a disease. PMS provides real-world evidence on drug performance and benefits patients.
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
Introduction to Pharmacovigilance Signal DetectionPerficient
This document provides an introduction to signal detection in pharmacovigilance. It defines key terms like signal and signal detection. It describes qualitative and quantitative signal detection methods including individual case review, data mining algorithms to calculate disproportionality ratios from large safety databases, and visualization tools. Challenges with signal detection include determining what constitutes a "large enough" safety database and assumptions made when using spontaneous reporting data. The document outlines the signal management process from detection to prioritization and evaluation.
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
This document provides an introduction to pharmacovigilance (PV). It defines PV as the science and practice of monitoring the effects of pharmaceutical products after they have been approved for market use. The key aspects of PV that are summarized include collecting, detecting, analyzing and preventing adverse drug reactions. PV aims to generate knowledge about drug safety profiles in order to improve treatments and protect public health. It works through a system of clinical trials, post-marketing surveillance, adverse reaction reporting and regulatory oversight.
Evaluating and Investigating Drug Safety Signals with Public DatabasesPerficient
This document provides an overview of databases that can be used to evaluate and investigate drug safety signals. It discusses common language and concepts in pharmacovigilance like signal detection, evaluation, and prioritization. It also describes online free databases like CDC WONDER and EU-ADR that can be used to search for drug-event pairs and investigate potential safety signals. Finally, it outlines some fee-based databases like those from Group Health Cooperative and Kaiser Permanente that contain patient healthcare records that can be used to conduct observational studies.
Signifcance of pharmacovigilance & risk management planAnsuman Parida
Pharmacovigilance is concerned with monitoring the safety of pharmaceutical drugs. It involves collecting, detecting, and assessing adverse drug reactions and preventing harm to patients. A risk management plan describes the known safety risks of a drug and outlines activities to further characterize risks, minimize risks to patients, and evaluate the effectiveness of risk minimization measures. Key parties in a risk management plan include patients, healthcare professionals, regulators, payers, pharmaceutical companies, and politicians. Risk management plans help ensure medications are reasonably safe and effective for their intended uses.
The document discusses pharmacovigilance, which involves monitoring the safety of medical products. It outlines various methods for collecting and analyzing adverse event reports, including spontaneous reports from healthcare professionals and patients, literature reviews, and solicited reports from clinical trials. It also discusses prioritizing cases, signal detection methods, and actions that may be taken in response to potential safety issues. The main objectives are to minimize risks for patients and the company while meeting regulatory requirements.
This document discusses post-marketing surveillance (PMS), which involves monitoring drugs after they reach the market to detect previously unrecognized effects. PMS is important for safety and improving products. Key goals are identifying adverse effects and characterizing incidence rates. Several methods are used in PMS, including voluntary reporting, controlled trials, cohort studies, and case-control studies. Cohort studies follow groups over time to assess outcomes, while case-control studies compare exposure rates between those with and without a disease. PMS provides real-world evidence on drug performance and benefits patients.
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
Introduction to Pharmacovigilance Signal DetectionPerficient
This document provides an introduction to signal detection in pharmacovigilance. It defines key terms like signal and signal detection. It describes qualitative and quantitative signal detection methods including individual case review, data mining algorithms to calculate disproportionality ratios from large safety databases, and visualization tools. Challenges with signal detection include determining what constitutes a "large enough" safety database and assumptions made when using spontaneous reporting data. The document outlines the signal management process from detection to prioritization and evaluation.
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
This document provides an introduction to pharmacovigilance (PV). It defines PV as the science and practice of monitoring the effects of pharmaceutical products after they have been approved for market use. The key aspects of PV that are summarized include collecting, detecting, analyzing and preventing adverse drug reactions. PV aims to generate knowledge about drug safety profiles in order to improve treatments and protect public health. It works through a system of clinical trials, post-marketing surveillance, adverse reaction reporting and regulatory oversight.
Evaluating and Investigating Drug Safety Signals with Public DatabasesPerficient
This document provides an overview of databases that can be used to evaluate and investigate drug safety signals. It discusses common language and concepts in pharmacovigilance like signal detection, evaluation, and prioritization. It also describes online free databases like CDC WONDER and EU-ADR that can be used to search for drug-event pairs and investigate potential safety signals. Finally, it outlines some fee-based databases like those from Group Health Cooperative and Kaiser Permanente that contain patient healthcare records that can be used to conduct observational studies.
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
ICH pharmacovigilance planning, an efficacy guidelinebibilicavesela
This document provides guidance for developing a pharmacovigilance plan, including a safety specification and action plan. It recommends summarizing important identified risks, potential risks, and missing safety information. The safety specification would then be used to develop a pharmacovigilance plan outlining routine monitoring and specific actions to address safety issues. Milestones should be set to evaluate safety results on a defined schedule. A variety of observational study methods are available to investigate particular safety concerns depending on the product, population, and type of risk being examined.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
Pharmaceutical Risk Benefit Assessment DIA AbstractLona Vincent
This document describes the development of an integrated framework for quantitative risk-benefit assessment of drugs. It aims to address the issue of some drugs being withdrawn from the market due to unfavorable risk profiles found in post-marketing safety data. The framework leverages existing qualitative models and presents a novel quantitative approach. It will classify measurement methods, demonstrate assigning importance to parameters, and exhibit the framework's predictive value by applying it to past drugs to improve decision making.
The document discusses challenges in pharmacovigilance including developing common platforms across locations and groups, integrating multiple databases, and implementing workflow management. It outlines Elsevier solutions to these challenges like automated literature monitoring to avoid missing safety signals, literature triage tools to save time, and integration with case reporting systems to connect literature to the broader ecosystem. The solutions aim to make pharmacovigilance teams more efficient, compliant, and able to better mitigate risk.
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
The document summarizes key points about pharmacovigilance from an industry perspective. It discusses the historical milestones that demonstrated the importance of pharmacovigilance. It then describes pharmacovigilance processes, including adverse event reporting, signal detection, and risk management plans. Finally, it outlines the new EU legislation's aim to strengthen and rationalize the EU pharmacovigilance system through requirements for pharmacovigilance systems and increased transparency.
This document provides an overview of pharmacovigilance systems and regulations in the US and EU. It describes regulatory oversight bodies, key regulations governing pharmacovigilance, safety reporting requirements during pre-marketing and post-marketing periods, pediatric legislation differences, and risk management strategies between the regions.
Risk-based approach to infectious disease safetyTGA Australia
The document discusses the TGA's risk-based approach to infectious disease safety for therapeutic goods like medicines, medical devices, and biologicals. It explains that the TGA conducts risk assessments to determine which infectious agents pose risks and require risk management measures. The risk assessment process involves identifying hazards, analyzing likelihood and consequences of harm, and evaluating overall risk levels. The TGA is establishing a systematic risk assessment approach using standardized criteria to allow for consistent evaluation and management of risks from infectious diseases in cellular therapies and tissues.
Common arab guidelines in pharmacovigilanceNahla Amin
The document outlines guidelines for good pharmacovigilance practices for Arab countries. It discusses 10 modules that cover key aspects of pharmacovigilance systems including quality systems, the pharmacovigilance system master file, inspections, audits, risk management, safety reporting and communication. The guidelines were developed by the Arab League to harmonize pharmacovigilance standards across countries in the region based largely on European Union guidelines. The guidelines aim to help national regulatory authorities ensure marketing authorization holders have appropriate systems, processes and resources for pharmacovigilance obligations.
This document discusses pharmacovigilance and the need for monitoring drug safety post approval. It describes how historical drug safety issues like the Elixir Sulfanilamide and Thalidomide tragedies revealed limitations in pre-approval testing and established the need for ongoing pharmacovigilance. The aims, application and reporting processes of pharmacovigilance are outlined along with terminology and examples of regulatory actions taken based on adverse event reporting.
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
Providing timely, evidence-based information on the safe and effective use of medicines, facilitating changes to healthcare practices, supporting risk minimization behavior.
Developing an effective yet transparent pharmacovigilance strategy and keeping ahead of regulatory changes can be challenging, yet the EU’s complex safety regulations and ever-increasing media attention make both functions vital.
At VIBpharma’s 5th annual Pharmacovigilance and Risk Management conference you will gain solutions to the issues you are currently facing; from the difficulties with RMP’s and how to effectively manage risk management with current medicines to mitigate any risks to patients.
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.
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.
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
ICH pharmacovigilance planning, an efficacy guidelinebibilicavesela
This document provides guidance for developing a pharmacovigilance plan, including a safety specification and action plan. It recommends summarizing important identified risks, potential risks, and missing safety information. The safety specification would then be used to develop a pharmacovigilance plan outlining routine monitoring and specific actions to address safety issues. Milestones should be set to evaluate safety results on a defined schedule. A variety of observational study methods are available to investigate particular safety concerns depending on the product, population, and type of risk being examined.
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
Pharmaceutical Risk Benefit Assessment DIA AbstractLona Vincent
This document describes the development of an integrated framework for quantitative risk-benefit assessment of drugs. It aims to address the issue of some drugs being withdrawn from the market due to unfavorable risk profiles found in post-marketing safety data. The framework leverages existing qualitative models and presents a novel quantitative approach. It will classify measurement methods, demonstrate assigning importance to parameters, and exhibit the framework's predictive value by applying it to past drugs to improve decision making.
The document discusses challenges in pharmacovigilance including developing common platforms across locations and groups, integrating multiple databases, and implementing workflow management. It outlines Elsevier solutions to these challenges like automated literature monitoring to avoid missing safety signals, literature triage tools to save time, and integration with case reporting systems to connect literature to the broader ecosystem. The solutions aim to make pharmacovigilance teams more efficient, compliant, and able to better mitigate risk.
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
The document summarizes key points about pharmacovigilance from an industry perspective. It discusses the historical milestones that demonstrated the importance of pharmacovigilance. It then describes pharmacovigilance processes, including adverse event reporting, signal detection, and risk management plans. Finally, it outlines the new EU legislation's aim to strengthen and rationalize the EU pharmacovigilance system through requirements for pharmacovigilance systems and increased transparency.
This document provides an overview of pharmacovigilance systems and regulations in the US and EU. It describes regulatory oversight bodies, key regulations governing pharmacovigilance, safety reporting requirements during pre-marketing and post-marketing periods, pediatric legislation differences, and risk management strategies between the regions.
Risk-based approach to infectious disease safetyTGA Australia
The document discusses the TGA's risk-based approach to infectious disease safety for therapeutic goods like medicines, medical devices, and biologicals. It explains that the TGA conducts risk assessments to determine which infectious agents pose risks and require risk management measures. The risk assessment process involves identifying hazards, analyzing likelihood and consequences of harm, and evaluating overall risk levels. The TGA is establishing a systematic risk assessment approach using standardized criteria to allow for consistent evaluation and management of risks from infectious diseases in cellular therapies and tissues.
Common arab guidelines in pharmacovigilanceNahla Amin
The document outlines guidelines for good pharmacovigilance practices for Arab countries. It discusses 10 modules that cover key aspects of pharmacovigilance systems including quality systems, the pharmacovigilance system master file, inspections, audits, risk management, safety reporting and communication. The guidelines were developed by the Arab League to harmonize pharmacovigilance standards across countries in the region based largely on European Union guidelines. The guidelines aim to help national regulatory authorities ensure marketing authorization holders have appropriate systems, processes and resources for pharmacovigilance obligations.
This document discusses pharmacovigilance and the need for monitoring drug safety post approval. It describes how historical drug safety issues like the Elixir Sulfanilamide and Thalidomide tragedies revealed limitations in pre-approval testing and established the need for ongoing pharmacovigilance. The aims, application and reporting processes of pharmacovigilance are outlined along with terminology and examples of regulatory actions taken based on adverse event reporting.
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
Providing timely, evidence-based information on the safe and effective use of medicines, facilitating changes to healthcare practices, supporting risk minimization behavior.
Developing an effective yet transparent pharmacovigilance strategy and keeping ahead of regulatory changes can be challenging, yet the EU’s complex safety regulations and ever-increasing media attention make both functions vital.
At VIBpharma’s 5th annual Pharmacovigilance and Risk Management conference you will gain solutions to the issues you are currently facing; from the difficulties with RMP’s and how to effectively manage risk management with current medicines to mitigate any risks to patients.
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.
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.
This document summarizes approaches to post-marketing surveillance of biological products, with a focus on vaccines. It discusses both passive surveillance methods like the Vaccine Adverse Event Reporting System (VAERS) and active surveillance efforts like the Vaccine Safety Datalink. The document also provides examples of recent vaccine safety issues that were identified through these surveillance systems and international collaboration on vaccine safety through organizations like the World Health Organization.
This document discusses pharmacovigilance in clinical trials, which involves monitoring the safety of medicines being tested. It outlines the responsibilities of various stakeholders like sponsors, investigators, and regulators in pharmacovigilance activities like adverse event reporting, risk assessment, and safety monitoring. Key aspects covered are the protocol guidance for safety reporting, use of case report forms and investigator brochures to document adverse drug reactions, and management of safety issues that arise during trials.
This document provides an introduction to post-marketing drug safety surveillance conducted by the FDA's Center for Drug Evaluation and Research (CDER). It defines pharmacovigilance and describes the Division of Pharmacovigilance's key roles in postmarketing safety monitoring, including collecting and analyzing adverse event reports from healthcare providers and patients. Spontaneous reporting systems like FDA Adverse Event Reporting System (FAERS) are useful for detecting rare or long-term safety issues not seen in clinical trials. The division evaluates safety signals and can recommend actions such as label changes or risk management plans based on its analyses.
Genable Technologies is developing RhoNova, a gene therapy using two AAV vectors, for the treatment of rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO-adRP), a genetic disorder causing progressive vision loss. RhoNova aims to overcome the diversity of over 200 RHO mutations by using RNA interference to destroy mutant RHO mRNA and replacing RHO through a gene resistant to mutations. Proof of concept has been shown in animal models. Orphan drug status has been granted and GMP manufacturing and preclinical toxicology studies are underway to enable clinical trials in 2017.
The document discusses the complex and unpredictable nature of the FDA drug approval process. While the steps of drug development may seem formulaic, including discovery, preclinical testing, and clinical trials, success is not guaranteed as programs face many risks and intangible factors. Understanding these challenges is important for mitigating risks and strategizing development approaches. The FDA approval process aims to ensure new drugs are safe and effective for patients.
This document summarizes a presentation on personalized medicine and companion diagnostics. It discusses:
1. How the FDA defines companion diagnostics and regulates them along with their corresponding drugs or therapies. This includes different types of biomarkers and validation requirements.
2. Key questions to consider regarding how a technology platform is used for infectious disease or oncology applications and in clinical decision making.
3. Examples of companion diagnostic technologies like tumor vaccines and an FDA approved test for Herceptin.
4. Potential regulatory pathways for companion diagnostic tests including clinical trials and clearance through 510(k) or PMA.
5. Conclusions that statistical analysis differs for co-developed drugs and diagnostics, and positioning a
Balancing post-market monitoring with pre-market requirementsTGA Australia
Dr Jane Cook discusses balancing pre-market requirements with post-market monitoring of new drugs. International trends show increased demand for early access to promising new therapies and different regulatory approaches between Europe and the US. This includes adaptive licensing in Europe and breakthrough therapy designation in the US. Ensuring benefits are realized requires effective post-market monitoring as initial trials may overstate benefits or overlook safety issues. Opportunities exist to learn from other regulators and focus on the drug lifecycle to confirm benefits, inform patients of limitations, and withdraw products if risks outweigh benefits.
This document provides an overview of pharmacovigilance and clinical trials. It discusses how clinical trials have multiple phases (preclinical, phases 1-4) to test drug safety and efficacy in humans. Pharmacovigilance involves collecting, detecting, assessing, monitoring and preventing adverse drug reactions post marketing. It is done through passive surveillance using spontaneous reporting as well as active surveillance with targeted follow up. Historical events like the sulfanilamide disaster and thalidomide tragedy revealed the importance of pharmacovigilance in ensuring drug safety.
The document discusses the various phases of clinical drug trials. Phase 3 trials involve large patient populations of 500-3000 people across multiple sites to confirm the drug's safety, effectiveness, and appropriate dosage. Phase 4 trials occur after marketing approval and involve post-marketing surveillance and pharmacovigilance to monitor long-term safety and effectiveness in an even larger population under regular medical practice. The overall goal of clinical trials is to generate necessary data to allow regulatory approval and safe medical use of new drugs.
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Principles of Drug Discovery and DevelopmentMANIKANDAN V
This document provides an overview of the drug development and approval process, including:
1) Drug discovery typically involves new disease insights, testing molecular compounds, existing treatments with unexpected effects, or new technologies. Thousands of candidates are narrowed down based on early testing.
2) Once a compound looks promising, development involves experiments to understand absorption, benefits, dosage, delivery method, side effects, and effectiveness compared to other drugs.
3) The FDA approval process includes multiple phases of clinical trials involving healthy volunteers and patients to evaluate safety, efficacy, and side effect management strategies before approval or accelerated approval in some cases.
The document provides an overview of the drug development and approval process at the US Food and Drug Administration (FDA). It describes the FDA's structure and responsibilities in regulating drugs, medical devices, food, cosmetics, and other products. The key stages of drug development include drug discovery, pre-clinical testing, clinical trials (Phase I-III), and new drug application. FDA approval is required through this rigorous process to ensure safety and effectiveness before a new drug can reach consumers.
This document discusses signal detection and management in pharmacovigilance. It provides a history of pharmacovigilance programs internationally and in India. It defines pharmacovigilance and outlines the objectives, processes, and steps involved in signal detection, validation, prioritization, assessment, and recommendation for action. These include ongoing monitoring of adverse event reports, identifying potential safety signals, validating signals based on factors like strength of association and biological plausibility, prioritizing signals based on impact and evidence, assessing signals, and recommending actions to address validated safety issues.
This document discusses signal detection and management in pharmacovigilance. It provides a brief history of pharmacovigilance programs internationally and in India. It defines pharmacovigilance and outlines the objectives, processes, and key steps involved in signal detection, validation, prioritization, assessment, and recommendation for action. These include ongoing monitoring of adverse event reports, signal detection methods, validation criteria, prioritization factors, signal assessment, and potential recommendations that may involve regulatory reporting, labeling changes, or additional studies. The goal is to identify potential safety issues and determine appropriate actions to prevent or minimize patient risk.
This document discusses challenges in using Bayesian and decision analysis approaches for regulating medical products. It notes issues like subjectivity in choosing priors, controlling type I error rates, and the need for legal availability of prior information. Promising areas for using prior information include pediatric trials, rare diseases, safety, and expedited access programs. Bayesian adaptive designs allow interim analyses to optimize sample size and model-based likelihoods. Decision analysis can make benefit-risk determinations more explicit through tools like influence diagrams and considering patient preferences. The highest value of Bayesian approaches is in accounting for external evidence, using flexible trial designs, modeling likelihoods, developing transparent decision rules based on factors like medical need and patient perspectives.
Similar to Fda guidance for post marketing study commitments professor pirouzi (20)
The document discusses career competencies in Canada, with a focus on availability and flexibility. It provides lists of universal employability skills, employability characteristics, and ways to build employability skills. Regarding availability and flexibility specifically, it notes they are important skills and employers want employees who can adapt to changes, accept new challenges, and be available for different situations. The document also discusses seven reasons why employees may not work as expected and how managers can address issues like unclear expectations, unwillingness to change, and lack of skills through improved communication, training, and support.
This document discusses communication skills and employability competencies in Canada. It identifies universal employability skills including leadership, communication, teamwork, problem-solving, and work ethic. Communication skills are a key employability competency. The document outlines the communication process, verbal and nonverbal communication methods, and decoding body language. It emphasizes that over 70% of communication is misunderstood and that nonverbal communication such as body language, eye contact, and gestures account for over 50% of the message received. Assertive communication styles are most effective for job interviews and interactions.
This document discusses career competencies in Canada, with a focus on creativity and reasoning skills. It was prepared and presented by Prof. Peivand Pirouzi. The document defines creativity skills as the use of imagination or original ideas. Reasoning skills are defined as thinking about something in a logical, sensible way. Several forms of reasoning are discussed, including deductive, inductive, abductive, and critical thinking. The document also provides examples of interview questions related to assessing creativity and reasoning skills.
Immigration and citizenship funded seminar - Prof. Peivand Pirouzi - Entrepreneurship and registration of a business corporation in Ontario, Canada
Speaker:
Prof. Peivand Pirouzi, Ph.D., MBA, CCPE, Cert. Psychiatry
Lead Education and Career Mentor for Immigrants and Refugees
http://www.linkedin.com/in/pirouzi
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This document introduces Professor Peivand Pirouzi and their credentials. It then provides an overview of the Crown Medical Research and Pharmaceutical Sciences College of Canada, including the programs offered related to various industries like pharmaceuticals, food, cosmetics, and natural health products. Example careers are described for jobs like clinical research associate, drug safety associate, quality assurance associate, and regulatory affairs associate. The document highlights the support provided by Crown for placements and networking opportunities.
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Immigration and Citizenship Canada - Professor Peivand Pirouzi - Funded Program for NYCH - Career competencies in Canada - Common sense skills
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Immigration and Citizenship Canada - Professor Peivand Pirouzi - Funded Program for NYCH - Career competencies in Canada - Availablity and Flexibility
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Pictorial and detailed description of patellar instability with sign and symptoms and how to diagnose , what investigations you should go with and how to approach with treatment options . I have presented this slide in my 2nd year junior residency in orthopedics at LLRM medical college Meerut and got good reviews for it
After getting it read you will definitely understand the topic.
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
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Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
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Gastritis and Gastric Health
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Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
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to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
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“Psychiatry and the Humanities”: An Innovative Course at the University of Mo...Université de Montréal
“Psychiatry and the Humanities”: An Innovative Course at the University of Montreal Expanding the medical model to embrace the humanities. Link: https://www.psychiatrictimes.com/view/-psychiatry-and-the-humanities-an-innovative-course-at-the-university-of-montreal
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
Fda guidance for post marketing study commitments professor pirouzi
1. FDA POST-MARKETING STUDY
COMMITMENTS FOR SAFETY
EVALUATION
Professor Peivand Pirouzi
2010
Food and Drug Administration Guidance
Publications
2. Outline
• Public health burden of serious adverse
drug events
• Reactions to drug safety systems
• Pre-approval drug evaluation
• Post-marketing safety evaluation
• Potential solutions
3. Serious Adverse Drug Events
The Magnitude
• Approximately 100,000 drug-induced deaths/yr
or the fifth leading cause of death
• Serious adverse drug events account for an
estimated 3-6% of all hospital admissions
• Approximately 700,000 patients go to an
Emergency Department for drug-induced,
related adverse events
• Enormous human and societal costs
4. Serious Adverse Drug Events
Time Trends
• From 1998 through 2005, 2.6-fold
increase (from 35,000 to 90,000)
• Reported events increased faster than
number of prescriptions
• Biotechnology products the worst
• 300 drugs accounted for 87% of all
reported events
Moore et al., Arch Intern Med 2007;167:1752-9
5. Sources of Drug Safety Information
Pre-approval
Phase 2 and 3 trials
Post-approval
Phase 4 trials
MedWatch (N = 422,889 in 2004)
Canada Vigilance
International data
6. Asymmetry in the Evaluation
• Approval is contingent on evidence of
efficacy from well-designed and adequately
powered clinical trials
• Such trials are generally not designed to
test specific hypotheses about safety
• The pre-market safety evaluation is often
exploratory
7. Pre-Approval Phases
Phase 1 Studies: Drug cautiously given to small
group of healthy volunteers (absorption,
metabolism, excretion, early indications)
Phase 2 Studies: Beneficial and adverse effects,
and dosing in a few hundred patients with the
targeted condition
Phase 3 Trials: Comparative trials to determine
benefit vs. harm involving thousands of patients.
Intended for regulatory approval and marketing
8. Pre-Approval Requirements
• New drugs intended for long-term use in
non-life threatening conditions:
• A minimum of 1,500 patients exposed
- 300 to 600 for 6 months
- 100 for a year
• Limits good evidence to: symptomatic
improvement, efficacy and common side
effects
9. Problems
• Insufficient patient safety information for
decision-making (approval
• Limited safety data for populations most
likely to be future users (elderly, those with
co-morbidities)
• Inadequate FDA review of design of studies
for NDAs to achieve optimal detection of
safety problems
• Safety signals, even when recognized, often
not actively pursued
10. Consequences
• Unsafe drug approved for marketing
• More than half have serious adverse drug events detected after
approval
• 10% have Black Box Warning added
• Average number of patients exposed prior to
withdrawal approximately 4 million
• Example: Vioxx exposed to 20 million patients before wirthdrawal
11. Vioxx
• A nonsteroidal anti-inflammatory drug (NSAID) that has now been
withdrawn over safety concerns. It was marketed by Merck & Co. to treat
osteoarthritis
•
• Approved as safe and effective by the Food and Drug Administration
(FDA) on May 20, 1999
• On September 30, 2004, Merck voluntarily withdrew rofecoxib from the
market because of concerns about increased risk of heart attack and
stroke associated with long-term, high-dosage use.
• In the year before withdrawal, Merck had sales revenue of US$2.5 billion from
Vioxx.
• FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart
attacks, 30 to 40 percent of which were probably fatal, in the five years the drug
was on the market.
12. Solutions – Pre-Approval
• More drug safety information -
- Larger and longer trials
- More relevant study populations
• More thorough FDA review of protocol
design
• Proactive FDA pursuit of safety signals
• Conditional approval, if safety problems
suspected
13. Post-market Commitments
• Today, 73% of new drugs have
commitments agreed to by sponsors
• Often multiple commitments by product
• First commitment was for levodopa (1970)
Therapeutic breakthrough for
symptomatic relief; no cure, so concerns
for long-term safety
14. Progress Report
# of open commitments 1,281
pending 911 (71%)
ongoing 173 (14%)
delayed 39 (3%)
submitted 157 (12%)
Federal Register, April 24, 2008
15. Problems
• Approval decisions rushed
• Unmet commitments for safety trials
• No penalties for failure to comply with post-approval
study commitments
• FDA lacks enforcement tools to leverage compliance
• FDA’s historic post-marketing safety surveillance
system is passive, insensitive and incomplete
• High threshold of safety threat needed before FDA
considers action (black box or withdrawal)
16. Solutions
• Unmet safety commitments by
manufacturers should be grounds for drug
withdrawal
• Authority to impose meaningful penalties
for failing to conduct safety trials
• Proactive post-marketing safety surveillance
• Lower threshold for FDA actions
17. New Authority and Enforcement
Tools
• FDA gets the authority to require post marketing studies
to identify or assess potential serious risks
• FDA can also initiate timely label changes or new post
marketing studies
• FDA may also use Risk Evaluation and Mitigation
Strategies to ensure benefits outweigh risks
• Failure to comply may result in a determination of
misbranding or escalating civil penalties
Psaty & Korn, JAMA 2007;298:2185-7
18. Risk Management and Regulation
Benefit Risk Balance
Risk identification
Risk Characterization
Recognized benefit
Adjustments
Revise tools to improve
Risk Minimization Tools
Benefit/risk balance
Risk reduction
Risk communication
Evaluation
Testing the tools
Reassess benefit/risk
balance
21. Access to Data and Active
Surveillance
• FDA required to establish an active post marketing
risk identification system
• The system is to include 25 million patients by July
1, 2010, and 100 million by July 1, 2012
• FDA to develop validated methods for the timely
identification of adverse events and potential drug
safety signals
• Congress allocated $25 million per year ($65
million in 2012)
Psaty & Korn, JAMA 2007;298:2185-7
22. Conclusions
• Current drug safety systems need
improvement - underway
• Proactive safety evaluations needed
• Retrospective - Database studies hold
promise
• Optimal compliance through understanding
of strategies and tools