Legislative/Regulatory Update (Congress activities, regulatory activities, AVMA stance) - Dr. Christine Hoang, Assistant Director, Scientific Activities Division, American Veterinary Medical Association, from the 2013 NIAA Merging Values and Technology conference, April 15-17, 2013, Louisville, KY, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2013-niaa-merging-values-and-technology
Who expert committee recommendations for pharmaceutical productsswati2084
The document summarizes the 43rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. It discusses WHO's work with other international organizations to harmonize pharmaceutical standards and guidelines. It provides updates on ongoing initiatives to improve access to quality medicines, including for priority diseases and children. Key areas of focus are ensuring safety and efficacy of medicines through good manufacturing practices, international reference standards, prequalification programs, and combating counterfeit drugs.
The document summarizes new rules and regulations around clinical trials and compensation in India put forth in 2019. Key changes include:
1) Tightened timelines for reporting serious adverse events like death - sponsors and investigators must report within 14 days, ethics committees within 30 days.
2) An expert committee may review injury cases and make recommendations to the licensing authority within 60 days.
3) The licensing authority must make a decision on compensation within 90 days for injuries or death, down from 150 days previously.
4) Formulas are provided to calculate compensation amounts based on factors like age, disability level, and hospitalization duration.
This document provides a procedure documentation list for quality improvement in healthcare facilities. It contains 10 chapters that cover topics such as access assessment and continuity of care, patient care, medication management, patient rights and education, infection control, continuous quality improvement, facility management and safety, human resource management, and information management systems. The list includes over 150 topics that healthcare facilities should document procedures for to improve quality. It is intended to help facilities standardize processes and ensure compliance with quality standards.
Pharmacovigilance is the science of monitoring the effects of pharmaceutical products after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. It aims to improve patient care and safety, public health, benefit-risk assessment of medicines, and understanding of pharmacovigilance. Similarly, materiovigilance monitors medical devices and hemovigilance monitors the blood transfusion system to protect patient safety. Adverse events following immunization (AEFI) surveillance also monitors vaccine safety. Together these systems aim to enhance safety across all medical treatments.
The document discusses various aspects of interacting with the FDA, including their missions, divisions, and processes for industry communication and drug approval. It outlines the FDA's roles in inspections, legal sanctions, scientific expertise, and product safety. It also describes methods for industry liaisons such as meetings, advisory committees, and Freedom of Information Act requests. The goal is to provide knowledge on planning effective interactions and navigating the drug approval process.
Guidelines on the collection verification and submission of reports on advers...Serkan Kaçar
Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency
The drug development and review process involves several stages. Drugs are first tested on animals to assess safety before human clinical trials. Clinical trials involve 3 phases testing on increasingly large groups of human subjects to evaluate safety, efficacy, and optimal dosage. If results are promising, drug sponsors submit a New Drug Application to the FDA including all trial data. The FDA thoroughly reviews the application over 6-10 months before approving the drug or requesting more information. Post-approval, the FDA continues monitoring the drug for safety issues and requires further studies if needed.
The document provides a quality audit checklist for healthcare organizations to create a quality culture. It outlines several key aspects that should be assessed such as clearly displaying the scope of services, patient rights, and information about the Ayushman Bharat program. Initial patient assessments, diagnostic test turnaround times, critical result reporting, mock code drills, informed consent processes, and anesthesia monitoring are among the factors discussed. The objective is to ensure patients receive timely, standardized, high-quality care in accordance with guidelines and to assess facilities on quality indicators.
Who expert committee recommendations for pharmaceutical productsswati2084
The document summarizes the 43rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. It discusses WHO's work with other international organizations to harmonize pharmaceutical standards and guidelines. It provides updates on ongoing initiatives to improve access to quality medicines, including for priority diseases and children. Key areas of focus are ensuring safety and efficacy of medicines through good manufacturing practices, international reference standards, prequalification programs, and combating counterfeit drugs.
The document summarizes new rules and regulations around clinical trials and compensation in India put forth in 2019. Key changes include:
1) Tightened timelines for reporting serious adverse events like death - sponsors and investigators must report within 14 days, ethics committees within 30 days.
2) An expert committee may review injury cases and make recommendations to the licensing authority within 60 days.
3) The licensing authority must make a decision on compensation within 90 days for injuries or death, down from 150 days previously.
4) Formulas are provided to calculate compensation amounts based on factors like age, disability level, and hospitalization duration.
This document provides a procedure documentation list for quality improvement in healthcare facilities. It contains 10 chapters that cover topics such as access assessment and continuity of care, patient care, medication management, patient rights and education, infection control, continuous quality improvement, facility management and safety, human resource management, and information management systems. The list includes over 150 topics that healthcare facilities should document procedures for to improve quality. It is intended to help facilities standardize processes and ensure compliance with quality standards.
Pharmacovigilance is the science of monitoring the effects of pharmaceutical products after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. It aims to improve patient care and safety, public health, benefit-risk assessment of medicines, and understanding of pharmacovigilance. Similarly, materiovigilance monitors medical devices and hemovigilance monitors the blood transfusion system to protect patient safety. Adverse events following immunization (AEFI) surveillance also monitors vaccine safety. Together these systems aim to enhance safety across all medical treatments.
The document discusses various aspects of interacting with the FDA, including their missions, divisions, and processes for industry communication and drug approval. It outlines the FDA's roles in inspections, legal sanctions, scientific expertise, and product safety. It also describes methods for industry liaisons such as meetings, advisory committees, and Freedom of Information Act requests. The goal is to provide knowledge on planning effective interactions and navigating the drug approval process.
Guidelines on the collection verification and submission of reports on advers...Serkan Kaçar
Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency
The drug development and review process involves several stages. Drugs are first tested on animals to assess safety before human clinical trials. Clinical trials involve 3 phases testing on increasingly large groups of human subjects to evaluate safety, efficacy, and optimal dosage. If results are promising, drug sponsors submit a New Drug Application to the FDA including all trial data. The FDA thoroughly reviews the application over 6-10 months before approving the drug or requesting more information. Post-approval, the FDA continues monitoring the drug for safety issues and requires further studies if needed.
The document provides a quality audit checklist for healthcare organizations to create a quality culture. It outlines several key aspects that should be assessed such as clearly displaying the scope of services, patient rights, and information about the Ayushman Bharat program. Initial patient assessments, diagnostic test turnaround times, critical result reporting, mock code drills, informed consent processes, and anesthesia monitoring are among the factors discussed. The objective is to ensure patients receive timely, standardized, high-quality care in accordance with guidelines and to assess facilities on quality indicators.
The document discusses post-marketing surveillance (PMS) of drugs. It notes that PMS is important for discovering undesirable effects that may occur after approval and provides additional information on drug risks and benefits. PMS systems collect reports of adverse drug reactions and ensure drug quality, efficacy, and safety after marketing. The document outlines various PMS methods like spontaneous reporting, cohort studies, and case-control studies that are used to identify potential drug effects in real-world use. Maintaining PMS is crucial to assuring patient safety.
Safety monitoring and reporting of adverse events of medical devices national...Vivek Nayak
This document outlines safety monitoring and adverse event reporting for medical devices from national and international perspectives. It defines medical devices and their classification system. Approval processes in India are discussed, along with the Materiovigilance Program of India for post-marketing surveillance. Adverse events must be reported within defined timeframes. International regulatory bodies like the FDA and MHRA also have mandatory reporting requirements. The limitations of current monitoring and reporting are noted.
Hemovigilance is a continuous process of monitoring blood transfusions to collect data on adverse reactions, investigate their causes, and prevent future occurrences. India launched a national Hemovigilance program in 2012 to address issues with adverse reactions from blood transfusions. The program collects reports from medical colleges on transfusion reactions and assesses causality to advise regulators on safety and provide recommendations to stakeholders. It aims to improve transfusion safety and prevent adverse events.
This document outlines 10 key regulatory requirements for conducting clinical trials in India. It defines what constitutes a new drug and clinical trial. It discusses the need for ethics committee approval and registration, informed consent, reporting of adverse events, and compensation for injuries. The document emphasizes that clinical sites must be prepared for inspection and certain non-drug intervention studies still require ethics approval and registration. Overall, it provides an overview of the regulatory framework and responsibilities for investigators conducting clinical research in India.
An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.
Post-marketing surveillance (PMS) monitors drug and medical device safety after market release using approaches like spontaneous reporting databases, prescription monitoring, and health records. PMS identifies potential safety issues through data review and helps detect rare or long-term adverse effects not seen in pre-market clinical trials which have limited patient populations and durations. PMS provides additional safety and efficacy information on marketed products and allows monitoring of special patient groups. Common PMS methods include spontaneous reporting, observational studies, randomized trials, and active surveillance networks.
Pharmacovigilance and Materiovigilance, Drugs and Cosmetics Actshashi sinha
Due to side effects of Medicines and Medical Devices increasing day by day it is important to monitor the Adverse Events arising out of use of Medicines and Medical Devices. The Pharmacovigilance and Materiovigilance monitors adverse events arising our of usage of Drugs and Medical Devices respectively. This chapter also deals with Drugs and Cosmetics Act 1940 and their important provisions.
Setting up of new pharmacovigilance centresPriti Gupta
Cure & Care Pharma proposes establishing a Pharmacovigilance Centre to monitor drug safety. The centre would be approved by regulatory authorities and function to collect, analyze and communicate information about adverse drug reactions and risks. The proposal outlines the need for pharmacovigilance due to increasing drug availability and irrational practices. It describes the centre's scope, reporting processes, infrastructure needs and budget to effectively oversee post-marketing drug safety.
HIGHLIGHTED: Dissemination of Patient-Specific Information from Devices by De...NextWorks
This is the highlighted version of FDA's Guidance for Industry: Dissemination of Patient-Specific Information from Devices by Device Manufacturers from June 2016.
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
The document provides a comparison of quality indicators between the 4th and 3rd editions of the NABH standards. It summarizes the key changes made to various quality indicators for monitoring access to care, care of patients, medication management, infection control, CQI processes, and other areas. For most indicators, the definitions and formulas for calculation remain the same between the editions, while some new indicators were added and the frequency of data collection was standardized in the 4th edition.
The document discusses Materiovigilance, which is the monitoring of incidents involving medical devices. It aims to study device-related incidents, enable dangerous devices to be removed from the market, and improve device quality and safety for patients. The Materiovigilance Programme of India was established in 2015 after incidents involving malfunctioning medical devices caused patient deaths. It oversees monitoring centers that collect adverse event reports which are analyzed to detect safety issues and support regulatory decision-making regarding medical devices in India.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
Guidelines for principles and rules for good clinical practices of advanced t...Serkan Kaçar
This document provides guidelines for good clinical practices regarding advanced therapy medicinal products. It defines key terms and outlines principles such as traceability from donor/source to subject. Responsibilities of various parties are described, including ensuring traceability systems are established and maintained. Safety reporting procedures are also covered, noting adverse events should be reported and a risk-based long-term follow-up plan for subjects established. The guidelines aim to regulate clinical trials of advanced therapies while protecting subject safety and welfare.
A Brief Guide to the FDA Drug Approval ProcessPerficient
The FDA drug approval process consists of 4 phases: pre-clinical testing on animals, clinical trials with humans (phases I-III), submission of a New Drug Application including all data, and post-marketing safety monitoring if approved. Phase I involves initial safety testing on 20-80 people. Phase II expands to hundreds of patients to preliminarily assess effectiveness. Phase III involves thousands of patients to further evaluate safety and effectiveness in various populations. If approved after review of the application and manufacturing facilities, the drug is monitored post-market for adverse events.
The document discusses pharmacovigilance and adverse drug reaction (ADR) reporting in India. It provides information on the national pharmacovigilance program, including who can report ADRs, how to report them, and the benefits of reporting. It describes the ADR reporting process and forms for healthcare professionals and consumers. It also discusses other vigilance programs in India related to medical devices, vaccines, blood products, and several research projects conducted with these programs.
This document outlines patient safety goals and standards. It defines key terms like risk and safety. It lists international patient safety goals such as identifying patients correctly and reducing healthcare associated infections. National patient safety goals are discussed in more detail and include accurately identifying patients, improving caregiver communication, safely using medications, reducing anticoagulant therapy harm, maintaining accurate medication information, reducing clinical alarm hazards, and preventing healthcare associated infections. The document provides specific requirements for implementing several of the national goals.
Drug safety evaluation in clinical trialVikas Sharma
This document discusses drug safety evaluation in clinical trials. It provides an overview of safety concerns, sources of safety information, safety monitoring and reporting requirements. Safety is evaluated using data from nonclinical studies, clinical trials and postmarketing reports. Adverse events are monitored and assessed for causality. Serious adverse events must be reported expediently to regulatory agencies. Ongoing evaluation is needed to identify unexpected or rare safety issues.
The Meaningful Use Stage 2 requirements include meeting or qualifying for exclusions to more objectives across core and menu sets compared to Stage 1. Eligible professionals must meet 17 core objectives and 5 menu objectives, while hospitals must meet 16 core and 2 menu objectives. Both must also report more clinical quality measures. The requirements focus on improving care coordination, patient engagement, population health, and privacy/security protections.
ICH GCP - Sponsor and Investigator's Responsibilities for Management of the I...Mallorie Mitchell-Dellac
This document discusses the responsibilities of sponsors and investigators in managing investigational products in clinical trials. It explains that sponsors must ensure sufficient nonclinical and clinical data support human use of investigational products. Sponsors are responsible for providing information on investigational products to investigators through investigator brochures. They must also properly store, package, label, and supply investigational products and placebos to investigators. Investigators are responsible for accountability of investigational products at trial sites and ensuring proper use by subjects according to protocols. Both sponsors and investigators must follow requirements for randomization and blinding in blinded trials.
11. political and regulatory aspects of veterinary antibiotics use in europeMerial EMEA
This document discusses the political and regulatory aspects of veterinary antibiotic use in Europe. It covers topics such as antibiotic resistance monitoring, responsible antibiotic use, and volumes and distribution of antibiotics. It notes that antibiotic resistance is an ongoing issue requiring measures like prudent antibiotic use, alternative disease prevention methods, and harmonized surveillance. The document advocates collecting antibiotic usage data and promoting responsible use frameworks as important parts of addressing antibiotic resistance in both animals and humans.
The document provides an overview of the history and branches of pharmacology. It discusses the nature and sources of drugs, how they enter the body, drug classification, and drugs associated with specific body systems like the gastrointestinal tract and respiratory system. Key developments in pharmacology throughout history are noted, from ancient Chinese and Egyptian medical texts to modern advances in biotechnology and drug delivery systems.
The document discusses post-marketing surveillance (PMS) of drugs. It notes that PMS is important for discovering undesirable effects that may occur after approval and provides additional information on drug risks and benefits. PMS systems collect reports of adverse drug reactions and ensure drug quality, efficacy, and safety after marketing. The document outlines various PMS methods like spontaneous reporting, cohort studies, and case-control studies that are used to identify potential drug effects in real-world use. Maintaining PMS is crucial to assuring patient safety.
Safety monitoring and reporting of adverse events of medical devices national...Vivek Nayak
This document outlines safety monitoring and adverse event reporting for medical devices from national and international perspectives. It defines medical devices and their classification system. Approval processes in India are discussed, along with the Materiovigilance Program of India for post-marketing surveillance. Adverse events must be reported within defined timeframes. International regulatory bodies like the FDA and MHRA also have mandatory reporting requirements. The limitations of current monitoring and reporting are noted.
Hemovigilance is a continuous process of monitoring blood transfusions to collect data on adverse reactions, investigate their causes, and prevent future occurrences. India launched a national Hemovigilance program in 2012 to address issues with adverse reactions from blood transfusions. The program collects reports from medical colleges on transfusion reactions and assesses causality to advise regulators on safety and provide recommendations to stakeholders. It aims to improve transfusion safety and prevent adverse events.
This document outlines 10 key regulatory requirements for conducting clinical trials in India. It defines what constitutes a new drug and clinical trial. It discusses the need for ethics committee approval and registration, informed consent, reporting of adverse events, and compensation for injuries. The document emphasizes that clinical sites must be prepared for inspection and certain non-drug intervention studies still require ethics approval and registration. Overall, it provides an overview of the regulatory framework and responsibilities for investigators conducting clinical research in India.
An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.
Post-marketing surveillance (PMS) monitors drug and medical device safety after market release using approaches like spontaneous reporting databases, prescription monitoring, and health records. PMS identifies potential safety issues through data review and helps detect rare or long-term adverse effects not seen in pre-market clinical trials which have limited patient populations and durations. PMS provides additional safety and efficacy information on marketed products and allows monitoring of special patient groups. Common PMS methods include spontaneous reporting, observational studies, randomized trials, and active surveillance networks.
Pharmacovigilance and Materiovigilance, Drugs and Cosmetics Actshashi sinha
Due to side effects of Medicines and Medical Devices increasing day by day it is important to monitor the Adverse Events arising out of use of Medicines and Medical Devices. The Pharmacovigilance and Materiovigilance monitors adverse events arising our of usage of Drugs and Medical Devices respectively. This chapter also deals with Drugs and Cosmetics Act 1940 and their important provisions.
Setting up of new pharmacovigilance centresPriti Gupta
Cure & Care Pharma proposes establishing a Pharmacovigilance Centre to monitor drug safety. The centre would be approved by regulatory authorities and function to collect, analyze and communicate information about adverse drug reactions and risks. The proposal outlines the need for pharmacovigilance due to increasing drug availability and irrational practices. It describes the centre's scope, reporting processes, infrastructure needs and budget to effectively oversee post-marketing drug safety.
HIGHLIGHTED: Dissemination of Patient-Specific Information from Devices by De...NextWorks
This is the highlighted version of FDA's Guidance for Industry: Dissemination of Patient-Specific Information from Devices by Device Manufacturers from June 2016.
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
The document provides a comparison of quality indicators between the 4th and 3rd editions of the NABH standards. It summarizes the key changes made to various quality indicators for monitoring access to care, care of patients, medication management, infection control, CQI processes, and other areas. For most indicators, the definitions and formulas for calculation remain the same between the editions, while some new indicators were added and the frequency of data collection was standardized in the 4th edition.
The document discusses Materiovigilance, which is the monitoring of incidents involving medical devices. It aims to study device-related incidents, enable dangerous devices to be removed from the market, and improve device quality and safety for patients. The Materiovigilance Programme of India was established in 2015 after incidents involving malfunctioning medical devices caused patient deaths. It oversees monitoring centers that collect adverse event reports which are analyzed to detect safety issues and support regulatory decision-making regarding medical devices in India.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
Guidelines for principles and rules for good clinical practices of advanced t...Serkan Kaçar
This document provides guidelines for good clinical practices regarding advanced therapy medicinal products. It defines key terms and outlines principles such as traceability from donor/source to subject. Responsibilities of various parties are described, including ensuring traceability systems are established and maintained. Safety reporting procedures are also covered, noting adverse events should be reported and a risk-based long-term follow-up plan for subjects established. The guidelines aim to regulate clinical trials of advanced therapies while protecting subject safety and welfare.
A Brief Guide to the FDA Drug Approval ProcessPerficient
The FDA drug approval process consists of 4 phases: pre-clinical testing on animals, clinical trials with humans (phases I-III), submission of a New Drug Application including all data, and post-marketing safety monitoring if approved. Phase I involves initial safety testing on 20-80 people. Phase II expands to hundreds of patients to preliminarily assess effectiveness. Phase III involves thousands of patients to further evaluate safety and effectiveness in various populations. If approved after review of the application and manufacturing facilities, the drug is monitored post-market for adverse events.
The document discusses pharmacovigilance and adverse drug reaction (ADR) reporting in India. It provides information on the national pharmacovigilance program, including who can report ADRs, how to report them, and the benefits of reporting. It describes the ADR reporting process and forms for healthcare professionals and consumers. It also discusses other vigilance programs in India related to medical devices, vaccines, blood products, and several research projects conducted with these programs.
This document outlines patient safety goals and standards. It defines key terms like risk and safety. It lists international patient safety goals such as identifying patients correctly and reducing healthcare associated infections. National patient safety goals are discussed in more detail and include accurately identifying patients, improving caregiver communication, safely using medications, reducing anticoagulant therapy harm, maintaining accurate medication information, reducing clinical alarm hazards, and preventing healthcare associated infections. The document provides specific requirements for implementing several of the national goals.
Drug safety evaluation in clinical trialVikas Sharma
This document discusses drug safety evaluation in clinical trials. It provides an overview of safety concerns, sources of safety information, safety monitoring and reporting requirements. Safety is evaluated using data from nonclinical studies, clinical trials and postmarketing reports. Adverse events are monitored and assessed for causality. Serious adverse events must be reported expediently to regulatory agencies. Ongoing evaluation is needed to identify unexpected or rare safety issues.
The Meaningful Use Stage 2 requirements include meeting or qualifying for exclusions to more objectives across core and menu sets compared to Stage 1. Eligible professionals must meet 17 core objectives and 5 menu objectives, while hospitals must meet 16 core and 2 menu objectives. Both must also report more clinical quality measures. The requirements focus on improving care coordination, patient engagement, population health, and privacy/security protections.
ICH GCP - Sponsor and Investigator's Responsibilities for Management of the I...Mallorie Mitchell-Dellac
This document discusses the responsibilities of sponsors and investigators in managing investigational products in clinical trials. It explains that sponsors must ensure sufficient nonclinical and clinical data support human use of investigational products. Sponsors are responsible for providing information on investigational products to investigators through investigator brochures. They must also properly store, package, label, and supply investigational products and placebos to investigators. Investigators are responsible for accountability of investigational products at trial sites and ensuring proper use by subjects according to protocols. Both sponsors and investigators must follow requirements for randomization and blinding in blinded trials.
11. political and regulatory aspects of veterinary antibiotics use in europeMerial EMEA
This document discusses the political and regulatory aspects of veterinary antibiotic use in Europe. It covers topics such as antibiotic resistance monitoring, responsible antibiotic use, and volumes and distribution of antibiotics. It notes that antibiotic resistance is an ongoing issue requiring measures like prudent antibiotic use, alternative disease prevention methods, and harmonized surveillance. The document advocates collecting antibiotic usage data and promoting responsible use frameworks as important parts of addressing antibiotic resistance in both animals and humans.
The document provides an overview of the history and branches of pharmacology. It discusses the nature and sources of drugs, how they enter the body, drug classification, and drugs associated with specific body systems like the gastrointestinal tract and respiratory system. Key developments in pharmacology throughout history are noted, from ancient Chinese and Egyptian medical texts to modern advances in biotechnology and drug delivery systems.
This document discusses linear and nonlinear pharmacokinetics. Linear pharmacokinetics follow first-order kinetics and nonlinear pharmacokinetics follow Michaelis-Menten kinetics. Nonlinearity can occur due to saturation of drug absorption, distribution, metabolism or excretion processes. The Michaelis-Menten equation can describe nonlinear kinetics and data plots of drug concentration versus time can indicate nonlinear behavior.
Godrej Agrovet is a subsidiary of Godrej Industries Ltd that holds 57% shares. Godrej Aadhaar is a rural development program with the motto "Khushiyon ka, Khushhali ka". It offers products and services to farmers through retail centers in various Indian states. The objectives are to improve productivity, increase returns and offer advisory services. It interacts with farmers daily to educate them and increase productivity. Opportunities exist in rural India due to the large population, rising incomes and improving infrastructure. Challenges include high initial costs, expanding to a vast market, and addressing many languages and communities.
The document discusses LG Electronics' strategy for tapping the rural Indian market. It highlights that rural India accounts for over 70% of the population and presents a large business opportunity. LG customized its products and marketing for rural consumers by developing affordable TV models priced at Rs. 3000-4900, establishing extensive distribution networks, and using mobile vans and local events to create awareness. LG also localized its products and menus to rural needs and preferences. This comprehensive rural strategy helped LG increase its rural sales contribution and emerge as a leader in the Indian consumer durables market.
ICICI Prudential Life Insurance is looking to expand into rural markets in select states in India. They want to target rural affluent customers in the SEC R1 and R2 categories. Their objective is to launch ICICI Prudential as a trusted and credible life insurance company for this target segment. The presentation discusses using market research tools to select priority districts and villages, understanding the rural customer, and developing a communication strategy aligned with ICICI Prudential's brand positioning of "being there at every step".
AMUL is a dairy cooperative in India owned by 3 million milk producers. Formed in 1946, it is managed by the Gujarat Cooperative Milk Marketing Federation and has become the largest food brand in India. AMUL spurred India's white revolution by making the country the largest producer of milk and milk products in the world. It derives 70% of its sales from rural areas through a three-tier model that eliminates middlemen and allows farmers to control procurement, processing and marketing with professional management.
Pharmaceutical industry and unit processibtihal osman
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
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This document discusses Godrej ChotuKool, a disruptive refrigeration product for rural India. It summarizes key trends affecting the refrigeration industry like food spoilage and low refrigerator penetration. It then introduces ChotuKool as addressing these issues through its affordable price, portability, small size, and ability to run on batteries. The document outlines challenges like scaling operations and segmentation. It proposes solutions like establishing manufacturing plants, low-cost distribution models, avoiding marketing myopia, and clear market segmentation. Finally, it analyzes the structure of the Indian consumer market.
Dr. Harry Snelson - Antibiotics and Veterinary Feed Directive: The times, the...John Blue
Antibiotics and Veterinary Feed Directive: The times, they are a changin' - Dr. Harry Snelson, American Association of Swine Veterinarians, from 2015 Summer Swine Health Seminar, August 22, 2015, Wrightsville Beach, North Carolina, USA.
More presentations at http://www.swinecast.com/2015-boehringer-ingelheim-carolina-swine-health-seminar
Dr. Chris Rademacher - Veterinary Feed Directive - PORK AcademyJohn Blue
Veterinary Feed Directive - PORK Academy - Dr. Chris Rademacher, Iowa State University, from the 2017 World Pork Expo, June 7 - 9, 2017, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2017-world-pork-expo
Dr. Jennifer Koeman, Dr. Harry Snelson - FDA Antibiotic GuidanceJohn Blue
FDA Antibiotic Guidance - Dr. Jennifer Koeman, National Pork Board; Dr. Harry Snelson, American Association Swine Veterinarians, from the 2015 World Pork Expo, June 3 - 5, 2015, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2015-world-pork-expo
Dr. Jennifer Koeman, National Pork Board; Dr. Harry Snelson, American Association Swine Veterinarians, from the 2015 World Pork Expo, June 3 - 5, 2015, Des Moines, IA, USA.
This document provides a summary of the National Agriculture Law Update presented at Tennessee College of Law's Agriculture Law & Policy Symposium on October 9, 2015. It discusses several key topics including the Veterinary Feed Directive which establishes new requirements for veterinary oversight of medically important antibiotics in animal feed. It also summarizes litigation over the definition of "waters of the United States" and lawsuits against Syngenta related to its genetically modified corn trait approval in China.
Dr. Eric Gordon - Discussion on the Veterinary Feed Directive Integration in ...John Blue
Discussion on the Veterinary Feed Directive Integration in Small Ruminant - Dr. Eric Gordon, The Ohio State University, from the 2017 NIAA Annual Conference, U.S. Animal Agriculture's Future Role In World Food Production - Obstacles & Opportunities, April 4 - 6, Columbus, OH, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2017_niaa_us_animal_ag_future_role_world_food_production
Dr. Christine Hoang - Veterinarian’s Oversight of AntimicrobialsJohn Blue
Veterinarian’s Oversight of Antimicrobials - Dr. Christine Hoang, American Veterinary Medical Association, from the 2012 Annual Conference of the National Institute for Animal Agriculture, March 26 - 29, Denver, CO, USA.
More presentations at: http://www.trufflemedia.com/agmedia/conference/2012-decreasing-resources-increasing-regulation-advance-animal-agriculture
This document discusses international efforts to harmonize standards for veterinary products. It describes the roles of organizations like Codex, OIE, VICH, and CVM in developing consensus standards. The goals are to ensure veterinary products are safe, effective, and of high quality globally in order to protect public health, animal health, and facilitate trade. Efforts focus on harmonizing requirements for product approval and regulation.
Lawyer's Guide to the Veterinary Feed DirectiveCari Rincker
This presentation was created for the Lawline.com presentation titled "Lawyer's Guide to the Veterinary Feed Directive." The Lawline presentation will be on November 3, 2016 at 3:30pm ET. The recording of the lecture will subsequently be available via Lawline.com at https://www.lawline.com/faculty/cari-rincker. This presentation is broken up in two parts: (1) General Background discussing definitions, regulatory players and the legal framework, and (2) the Second VFD Rule promulgated in June 2015.
This document summarizes key aspects of veterinary pharmacy in the UK, including governing legislation, regulatory bodies, drug classifications, prescribing and dispensing requirements. The Veterinary Medicines Regulations control all aspects of veterinary medicines and are reviewed annually. The Veterinary Medicines Directorate regulates licensing of animal medicines to ensure safety. Pharmacists must follow strict rules for dispensing prescription-only and controlled drugs for animals, record keeping, and reporting adverse drug reactions. Professional development courses and groups help pharmacists stay informed on veterinary pharmacy issues.
Dr. Chris Rademacher - Veterinary Feed Directives Are Here: What Have You Done?John Blue
Veterinary Feed Directives Are Here: What Have You Done? - Dr. Chris Rademacher, Iowa State University, from the 2017 Iowa Pork Congress, January 25-26, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2017-iowa-pork-congress
Dr. Matt Anderson - Antibiotic use and future records necessary to keep the g...John Blue
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1. Veterinarians and Antimicrobial Use
Legislative & Regulatory Update
Christine Hoang, DVM, MPH, CPH
American Veterinary Medical Association
choang@avma.org
2. Pew Health Professions Commission in
Health America: Practitioners for 2005
“Veterinarians are more knowledgeable about the impact of
animals and diseases on human health and the role and use of
animals in the improvement of health and well-being than any
other health professional in most communities. Thus
veterinarians should be more directly available to human
health providers for consultation on these subjects.”
3. Role of the Veterinarian
• AVMA Role of the Veterinarian Policy: Veterinarians should be involved in
the decision-making process for the use of antimicrobials in animals
regardless of the distribution channels through which the antimicrobials
were obtained.
– Additionally, the FDA references the veterinarian’s role in their Guidance for
Industry #209 - The Judicious Use of Medically Important Antimicrobial Drugs
in Food-Producing Animals in defining greater veterinary oversight.
• “Veterinary involvement in the decision-making process associated with
the use of medically important antimicrobial drugs is an important aspect
of assuring appropriate use, including judicious prevention use.”
• AVMA Judicious Use Policy: “When the decision is reached to use
antimicrobials for therapy, veterinarians should strive to optimize
therapeutic efficacy and minimize resistance to antimicrobials to protect
public and animal health.” … “Judicious use of antimicrobials, when under
the direction of a veterinarian, should meet all requirements of a
veterinarian-client-patient relationship.”
4. VCPR = oversight
The veterinarian-client-patient relationship (or
VCPR) is the basis for interaction among
veterinarians, their clients, and their patients.
• the veterinarian is personally acquainted with the
keeping and care of the patient
• The veterinarian provides oversight of
treatment, compliance and outcome
• Patient records are maintained
5. AVMA:
• MVPA = Model Veterinary Practice
Act
• PVME = Principles of Veterinary
Medical Ethics
FDA:
• AMDUCA = Animal Medicinal Drug
Use Clarification Act (AVMA and FDA
Info) for Extra-Label Drug Use
• VFD = Veterinary Feed Directive
(currently, but is not in the proposed
draft text for VFDs)
Where does it live?
• State Practice Acts
6. AMDUCA
• (i) A valid veterinarian-client-patient relationship is one in which:
• (1) A veterinarian has assumed the responsibility for making medical judgments regarding the health of
(an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or
other caretaker) has agreed to follow the instructions of the veterinarian;
• (2) There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or
preliminary diagnosis of the medical condition of the animal(s); and
• (3) The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of
the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is
personally acquainted with the keeping and care of the animal(s) by virtue of examination of the
animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.
7. Model Veterinary Practice Act
The AVMA Model Veterinary Practice Act is to serve as a set of guiding principles for state regulation of
the practice of veterinary medicine.
• The commentary to the model act explains that states may wish to further specify that
when establishing a VCPR in the case of large operations, “sufficient knowledge” of the
patient can be supplemented by means of:
– 1) examination of health, laboratory, or production records;
– 2) consultation with owners, caretakers or supervisory staff regarding a health management
program for the patient; or
– 3) information regarding the local epidemiology of diseases for the appropriate species.
8. Current MVPA
https://www.avma.org/KB/Policies/Pages/Model-Veterinary-Practice-Act.aspx
“Veterinarian-client-patient relationship” means that all of the following are required:
– The veterinarian has assumed the responsibility for making medical judgments regarding the health
of the patient and the client has agreed to follow the veterinarian’s instructions.
– The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary
diagnosis of the medical condition of the patient. This means that the veterinarian is personally
acquainted with the keeping and care of the patient by virtue of:
• a timely examination of the patient by the veterinarian, or
• medically appropriate and timely visits by the veterinarian to the operation where the patient
is managed.
– The veterinarian is readily available for follow-up evaluation or has arranged for the following:
• veterinary emergency coverage, and
• continuing care and treatment.
– The veterinarian provides oversight of treatment, compliance and outcome.
– Patient records are maintained.
9. Commentary to Section 2• The definition of “veterinarian-client-patient relationship” (VCPR) in subsection 20 was changed in 2012, and is now different from that embodied
in federal regulation 21 CFR 530.3(i) relating to extralabel drug use.
• In 2012, subsection 14 was revised to define “patient” as “an animal or group of animals.” Therefore, the definition of VCPR can be applied to
individual animals as well as a group or groups of animals within an operation (production system).
• The AVMA recognizes that individual states may wish to more clearly define specific terms within the definition of VCPR. For example, a state
regulatory board may wish to include a specific time period (eg, no less frequent than 6 or 12 months) to better delineate the term “timely” relating
to examinations and visits. The term “timely” should be considered in light of the nature and circumstances of the patient (eg, species, condition or
disease, or operation).
• In 2012, subsections 20-b and 20-c were revised for purposes of clarification. Subsection 20-d was added to state that patient records must be
maintained to establish a VCPR.
• States may also wish to further specify that when establishing a VCPR in the case of large operations, “sufficient knowledge” can be supplemented
by means of:
1. examination of health, laboratory, or production records; or
2. consultation with owners, caretakers or supervisory staff regarding a health management program for the patient; or
3. information regarding the local epidemiology of diseases for the appropriate species.
10. Principles of Veterinary Medical Ethics
• Regardless of practice ownership, the interests of the patient, client, and public require that
all decisions that affect diagnosis, care, and treatment of patients are made by veterinarians.
• The responsibilities of the veterinary profession extend…to society in general. Veterinarians
are encouraged… to provide their services for activities that protect public health.
• Dispensing or prescribing a prescription product requires a VCPR
– Without a VCPR, veterinarians merchandising or… use of any pharmaceutical is
unethical...
• Veterinarians are responsible for choosing the treatment regimens for their patients.
• It is against our ethics to:
– be influenced by considerations other than the needs of the patient, the welfare of the
client, and the safety of the public.
– allow medical judgment to be influenced by agreements by which they stand to profit
through …products.
11. Prescription Requirements
• 21 USC chapter 9
– Established by AMDUCA for Extra-Label Drug Use– 1994 (summary) & FRN
• On pages 437 & 438 under New animal drugs in Section 360b (4)&(5)-“is
by or on the lawful written or oral order of a licensed veterinarian within
the context of a veterinarian-client- patient relationship, as defined by the
Secretary”
– ADAA – 1996 (summary)
• On page 300 - (a) Lawful veterinary feed directive requirement - “to use
under the professional supervision of a licensed veterinarian” … “Any
animal feed bearing or containing a veterinary feed directive drug shall be
fed to animals only by or upon a lawful veterinary feed directive issued by
a licensed veterinarian in the course of the veterinarian's professional
practice.”
12. CFR Verbiage on VCPR and VFDs• Veterinary Feed Directive; Current Regulation
– 21 CFR Part 558.3 - “A veterinarian may issue a VFD only if a valid
– veterinarian-client-patient relationship exists, as defined in § 530.3(i) of this
chapter.”
– 21 CFR Part 558.6 – “You must issue a VFD only within the confines of a valid
veterinarian-client- patient relationship (see definition at § 530.3(i) of this chapter)”
• Veterinary Feed Directive; Draft Text for Proposed Regulation
– 21 CFR Part 558.3 - A ‘‘veterinary feed directive’’ is a written statement issued by a
licensed veterinarian in the course of the veterinarian’s professional practice that
orders the use of a VFD drug in or on an animal feed. This written statement
authorizes the client (the owner of the animal or animals or other caretaker) to obtain
and use the VFD drug in or on an animal feed to treat the client’s animals only in
accordance with the directions for use approved, conditionally approved, or indexed
by the Food and Drug Administration (FDA).
– 21 CFR Part 558.6 - The veterinarian may only issue a VFD for use in animals under
his or her supervision or oversight in the course of his or her professional
practice, and in compliance with all applicable veterinary licensing and practice
requirements.
c
c
c
c
13. Next…
• State Practice Acts
• MVPA, PVME, other AVMA policies
• Species specific “BMP’s” ???
14. Prescription Requirements
• 21 USC chapter 9
– Established by GADPTRA – 1988 (summary)
• The language is in the USC in Section 353(f) Veterinary prescription drugs
on page 287 where it states “(4) A drug which is subject to paragraph (1)
shall be deemed to be misbranded if at any time prior to dispensing its
label fails to bear the statement "Caution: Federal law restricts this drug
to use by or on the order of a licensed veterinarian." A drug to which
paragraph (1) does not apply shall be deemed to be misbranded if at any
time prior to dispensing its label bears the statement specified in the
preceding sentence.
• On page 286-287 under veterinary prescription drugs (see highlighted
section in attached doc on those pages) – This states “shall be dispensed
only by or upon the lawful written or oral order of a licensed veterinarian
in the course of the veterinarian's professional practice”
15. How Vets work with Producers
Within the Veterinarian-Client-Patient-Relationship (VCPR) -
the producer is the “client” component of that relationship.
• assist producers in complying with their industry’s quality
assurance programs (that also contain the concepts below)
• work closely with producers to ensure the health and
welfare of their animals
• AVMA Judicious Use Policy: “Veterinarians should work
with those responsible for the care of animals to use
antimicrobials judiciously regardless of the distribution
system through which the antimicrobial was obtained.”
16. AVMA Efforts
Veterinary Foresight and Expertise in
Antimicrobial Discussions
AVMA Policy: AVMA recognizes that
veterinarians need to be involved in discussions
relative to judicious use of antimicrobials and
food supply veterinary medicine… to ensure that
risks and benefits to both humans and animals
are given due consideration.
17. AVMA Efforts
Numerous issue specific Task Forces and Steering
Committees as well as standing Councils and
Committees to provide guidance on these issues.
• 2009-2010 AVMA’s Antimicrobial Use Task Force
• 2010- present AVMA Steering Committee for
FDA Policy on Veterinary Oversight of
Antimicrobials.
18. Streamlining the VFD
The AVMA’s Steering Committee for Veterinary Oversight:
– engaged with the FDA as it proposed changes to the Veterinary Feed Directive (VFD) to
make it more workable and to gain greater veterinary oversight. Much of the feedback
provided by the Steering Committee was incorporated into the FDA’s VFD Draft Text for
Proposed Regulation published in July 2012
• The Veterinary Feed Directive (VFD) is the primary vehicle for greater veterinary
oversight of antimicrobials in feed
– continues to collaborate with the FDA to provide guidance from the veterinary
perspective and clarify veterinarians’ role in the oversight of antimicrobial use in animals
as regulatory changes are made to address antimicrobial resistance.
19. Listening Sessions
• The FDA has organized, in conjunction with USDA, 5 listening
sessions to be held throughout the country to hear input on the
implementation of its initiative for the judicious use of
antimicrobials in medicated feed or drinking water of food-
producing animals.
• AVMA is participating in these sessions given the importance and
role of the veterinary workforce in implementing changes.
• Information gleaned from these listening sessions will be provided
to AVMA decision makers (in addition to FDA and USDA) to enhance
understanding of the concerns associated with the FDA’s initiative
as we all continue working to enhance veterinary oversight.
20. Legislation
• Preservation of Antibiotics for Medical Treatment Act (PAMTA) - To amend
the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of
medically important antimicrobials.
• Delivering Antimicrobial Transparency in Animals (DATA Act) - To amend
the Federal Food, Drug, and Cosmetic Act to enhance the reporting
requirements pertaining to use of antimicrobial drugs in food animals.
• Animal Drug User Fee Act (ADUFA) - To amend the Federal Food, Drug,
and Cosmetic Act to reauthorize user fee programs relating to new animal
drugs and generic new animal drugs.
21. PAMTA
• The 113th Congressional version of the bill several changes from previous
iterations.
• The legislation now covers cephalosporins, bringing the total to eight classes of
medically important antibiotics that would be banned from “non-therapeutic”
uses (any kind of penicillin, tetracycline, macrolide, lincosamide, streptogramin,
aminoglycoside, sulfonamide, or cephalosporin).
• The measure also clarifies what is considered non-therapeutic “to ensure that any
use of medically important antibiotics outside of treatment of a sick animal is not
permitted,” according to Slaughter’s office.
22. PAMTA - Definitions
• ‘therapeutic use’, with respect to a medically important antimicrobial, means the use of
antimicrobials for the specific purpose of treating an animal with a documented disease or
infection. Such term does not include the continued use of such an antimicrobial in the animal
after the disease or infection is resolved.
• ‘nontherapeutic use’—
– “(i) means administration of antibiotics to an animal through feed and water (or, in poultry hatcheries,
through any means) for purposes (such as growth promotion, feed efficiency, weight gain, or disease
prevention) other than therapeutic use or nonroutine disease control; and
– “(ii) includes any repeated or regular pattern of use of medically important antimicrobials for purposes
other than therapeutic use or nonroutine disease control.
• ‘noncustomary situation’ does not include normal or standard practice and conditions on the
premises that facilitate the transmission of disease.
• ‘nonroutine disease control’ means the use of antibiotics on an animal that is not sick but
where it can be shown that a particular disease or infection is present, or is likely to occur
because of a specific, noncustomary situation, on the premises at the barn, house, pen, or
other level at which the animal is kept.
23. PAMTA - Prohibitions
It shall be unlawful to administer (including by means of animal feed) a medically important antimicrobial to a food-producing animal for
nonroutine disease control unless—
– (1) there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing
animal;
– (2) the administration of the medically important antimicrobial to the food-producing animal is necessary to prevent or
reduce the risk of transmission of the disease or infection described in paragraph (1);
– (3) the medically important antimicrobial is administered to the food-producing animal for nonroutine disease control for the
shortest duration possible to prevent or reduce the risk of transmission of the disease or infection described in paragraph (1)
to the animal; and
– (4) the medically important antimicrobial is administered—
• (A) at a scale no greater than the barn, house, or pen level; and
• (B) to the fewest animals possible to prevent or reduce the risk of transmission of the disease or infection described in
paragraph (1).
24. DATA Act
• enhanced reporting requirements
• to increase collaboration and coordination with the Secretary of
Agriculture to expand and coordinate the collection of data on the use of
antimicrobial drugs in or on cattle, swine, chickens, turkeys, and such
other food-producing animal species.
• to publish a final version of draft guidance #213
• to conduct a study evaluating
– (A) the voluntary approach used by the Food and Drug Administration
to eliminate injudicious use of antimicrobial drugs in food-producing
animals; and
– (B) the effectiveness of the data collection activities conducted by the
FDA regarding antimicrobial resistance.
25. ADUFA
• authorizes the FDA to collect fees from animal health companies to enable the Center for
Veterinary Medicine (CVM) to meet performance standards.
• ADUFA II will sunset in September 2013 and is scheduled to be reauthorized this year
Legislative Changes
• FDA will allow for multiple conditional approved indications on a single product label and
remove the requirement that indexed drugs be labeled “not FDA approved” for Minor
Use/Minor Species products
• Require notification of drug approvals on FDA’s website with the option to publish in the
Federal Register
Patient record requirement is also in PVME and means if you are recommendingmeds you have to keep record of it
Animal medicinal drug use clarification act
Last point = we don’t sell drugs for profit therefore vet oversight is not driven by an incentive to make money
Generic Animal Drug and Patent Term Restoration Act
greater oversight = greater judiciousness because of the VCPR, and the vets making medical decisions according to our policies (judicious use policy) and ethics.