This document provides an overview of industry and FDA liaison as well as ICH-Q guidelines. It discusses the roles and responsibilities of the FDA, including inspections, legal actions, and scientific review. It also describes the organization of the FDA and initiatives to expedite drug approval. Finally, it introduces ICH as an international harmonization effort and outlines the various ICH working groups and Q guidelines related to quality, safety, efficacy and other topics.
This document provides a summary of ICH (International Conference on Harmonisation) guidelines. It discusses the purpose of ICH in harmonizing technical requirements for pharmaceutical registration across regions to ensure safety and efficacy. ICH guidelines cover topics like nonclinical safety studies, clinical safety data, stability testing, and electronic submission of safety reports. The document outlines the structure of ICH including its steering committee and working groups and describes how guidelines are developed and can be used by regulators and industry globally.
This document provides information about the US Food and Drug Administration (FDA). It describes the organization and responsibilities of the FDA, including protecting public health by regulating food, drugs, medical devices, and other products. It also summarizes key FDA centers like the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The document introduces the Pharmaceutical Inspection Convention, its objectives to harmonize good manufacturing practices among countries.
The document discusses international harmonization in the pharmaceutical industry. It defines regulatory harmonization as making technical guidelines uniform across countries. It describes international organizations that work on harmonization, like ICH which brings together regulators from Europe, Japan, US, and others. Harmonization has benefits like faster drug approvals and reduced costs, but also risks like potentially weakening public health protections and limiting competition. The document also discusses pharmaceutical regulation and harmonization challenges in Pakistan, like weak domestic regulation, an emphasis on price controls over quality, and lack of investment in quality and GMP compliance.
Unauthorised and unregulated drugs lacking generic identities have flooded the local market through misleading advertising campaigns. These drugs are prescribed by some doctors in large quantities without knowing their effects. Loophole in laws allow import of herbal concoctions falsely labeled as drugs. Stricter implementation of National Drugs Policy is needed to regulate drug importation, distribution and sales. Random quality checks and making importers liable for failed batches can improve screening of imported drugs. Patients' rights include being informed of treatment risks and alternatives to expensive brands lacking proven benefits.
Pharmacovigilance (PV) plays a crucial role in ensuring the safety of drugs and monitoring their adverse effects. During an interview for a pharmacovigilance position or a related role, you may come across questions about the uses and importance of pharmacovigilance. Here are some potential interview questions related to the uses of pharmacovigilance
This document provides an overview of drug regulatory affairs. It defines regulatory affairs as the profession that acts as the interface between pharmaceutical industries and drug regulatory authorities. The goal of regulatory affairs professionals is to protect human health by ensuring safety, efficacy and quality of drugs and ensuring accurate product information. It discusses why regulatory affairs is needed, highlighting past drug tragedies that led to increased regulation. Regulatory affairs helps reduce development failures and provides assistance on issues like licensing, registration, development, manufacturing and quality guidance.
This document provides an overview of industry and FDA liaison as well as ICH-Q guidelines. It discusses the roles and responsibilities of the FDA, including inspections, legal actions, and scientific review. It also describes the organization of the FDA and initiatives to expedite drug approval. Finally, it introduces ICH as an international harmonization effort and outlines the various ICH working groups and Q guidelines related to quality, safety, efficacy and other topics.
This document provides a summary of ICH (International Conference on Harmonisation) guidelines. It discusses the purpose of ICH in harmonizing technical requirements for pharmaceutical registration across regions to ensure safety and efficacy. ICH guidelines cover topics like nonclinical safety studies, clinical safety data, stability testing, and electronic submission of safety reports. The document outlines the structure of ICH including its steering committee and working groups and describes how guidelines are developed and can be used by regulators and industry globally.
This document provides information about the US Food and Drug Administration (FDA). It describes the organization and responsibilities of the FDA, including protecting public health by regulating food, drugs, medical devices, and other products. It also summarizes key FDA centers like the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The document introduces the Pharmaceutical Inspection Convention, its objectives to harmonize good manufacturing practices among countries.
The document discusses international harmonization in the pharmaceutical industry. It defines regulatory harmonization as making technical guidelines uniform across countries. It describes international organizations that work on harmonization, like ICH which brings together regulators from Europe, Japan, US, and others. Harmonization has benefits like faster drug approvals and reduced costs, but also risks like potentially weakening public health protections and limiting competition. The document also discusses pharmaceutical regulation and harmonization challenges in Pakistan, like weak domestic regulation, an emphasis on price controls over quality, and lack of investment in quality and GMP compliance.
Unauthorised and unregulated drugs lacking generic identities have flooded the local market through misleading advertising campaigns. These drugs are prescribed by some doctors in large quantities without knowing their effects. Loophole in laws allow import of herbal concoctions falsely labeled as drugs. Stricter implementation of National Drugs Policy is needed to regulate drug importation, distribution and sales. Random quality checks and making importers liable for failed batches can improve screening of imported drugs. Patients' rights include being informed of treatment risks and alternatives to expensive brands lacking proven benefits.
Pharmacovigilance (PV) plays a crucial role in ensuring the safety of drugs and monitoring their adverse effects. During an interview for a pharmacovigilance position or a related role, you may come across questions about the uses and importance of pharmacovigilance. Here are some potential interview questions related to the uses of pharmacovigilance
This document provides an overview of drug regulatory affairs. It defines regulatory affairs as the profession that acts as the interface between pharmaceutical industries and drug regulatory authorities. The goal of regulatory affairs professionals is to protect human health by ensuring safety, efficacy and quality of drugs and ensuring accurate product information. It discusses why regulatory affairs is needed, highlighting past drug tragedies that led to increased regulation. Regulatory affairs helps reduce development failures and provides assistance on issues like licensing, registration, development, manufacturing and quality guidance.
This document provides an overview of drug regulatory affairs. It discusses the learning objectives which are to gain knowledge about regulatory processes, laws, and working within a regulatory environment. It defines regulatory affairs as the interface between pharmaceutical companies and drug authorities. The goal is to ensure safety, efficacy and quality of drugs. It discusses some drug tragedies in the past that led to the need for regulatory affairs and authorities like the FDA. Regulatory affairs professionals help companies work within this regulatory system and reduce development failures. Their role is to gather relevant information and assist companies on various regulatory issues from licensing to pharmacovigilance. Major global regulatory authorities are also named.
Post marketing surveilance, outsourcing BA and BE to CROJahnabi Sarmah
This document discusses post-marketing surveillance, outsourcing bioavailability and bioequivalence studies to contract research organizations. It provides an introduction to post-marketing surveillance, describing its role in monitoring drug safety after market approval. A brief history is given of pivotal drug safety issues that led to the establishment of formal post-marketing surveillance systems. Common sources of post-marketing information are also outlined. The document defines outsourcing, bioavailability, bioequivalence, and contract research organizations. It explains how outsourcing is used to reduce costs and improve efficiency through utilizing external partners for certain studies and services.
This document discusses the role and importance of regulatory affairs professionals in the pharmaceutical industry. It notes that regulatory affairs professionals ensure companies comply with relevant laws and regulations, advise on regulatory strategies and requirements, and facilitate the approval and marketing of drugs by communicating with regulatory agencies. Their work is important for developing innovative products and accelerating time to market while ensuring safety, efficacy and compliance.
This document provides information about the 5th Pharmacovigilance Congregation conference taking place on November 20th, 2013 in Mumbai, India. The conference will discuss ensuring safer drugs reach the market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature keynote speakers from various pharmaceutical companies and overviews of the latest challenges and opportunities in pharmacovigilance. The event aims to provide a platform for stakeholders to discuss best practices and advancing pharmacovigilance in India.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
This document provides a summary of common regulatory affairs job interview questions and answers. It begins with defining regulatory affairs and its goals of protecting human health, ensuring drug safety and efficacy, and ensuring accurate product information. It then discusses the roles of regulatory affairs professionals in interacting with regulatory agencies, preparing submissions, and ensuring compliance. The rest of the document provides answers to common interview questions about regulatory submissions, guidelines, authorities, and key concepts and legislation related to drug approval.
Pharmacovigilance Interview Question Part 1ClinosolIndia
"Pharmacovigilance Interview Question Part 1." In this insightful presentation, we delve into the crucial world of pharmacovigilance, exploring fundamental concepts and key questions that play a pivotal role in ensuring drug safety and healthcare integrity.
Embarking on a journey into the intricate realm of drug safety, 'Exploring the Foundations of Pharmacovigilance: Part 1' lays the groundwork for a comprehensive understanding of this crucial field. This segment serves as a gateway to the fundamental principles that underpin pharmacovigilance, unraveling the intricacies of adverse drug reaction monitoring and reporting. Delving into the significance of pharmacovigilance in ensuring patient safety, the exploration encompasses the key concepts and processes that form the backbone of drug safety surveillance. From identifying adverse events to understanding the roles of healthcare professionals and regulatory bodies, 'Part 1' provides a solid foundation for both novices and seasoned professionals alike. As we navigate through this informative chapter, the importance of robust pharmacovigilance practices in the ever-evolving landscape of healthcare becomes increasingly evident, setting the stage for the advanced concepts and global perspectives to follow in subsequent parts of this insightful series.
The document discusses WHO guidelines on rational medicine use and types of irrational medicine use. It notes that more than half of global medicine use is irrational, costing money and reducing treatment effectiveness. Irrational use includes polypharmacy, inappropriate antibiotic use, overuse of injections, and self-medication without prescriptions. The document lists several causes of irrational use, such as the natural history of illnesses, pseudo-logic, advertising influence on prescribers, and the perception that injections are always better than oral medications. Addressing irrational medicine use is important for improving health outcomes and efficient use of resources.
This document discusses quality control and quality assurance for veterinary dosage forms. It begins by defining Good Manufacturing Practices (GMP) which outline the production and testing aspects that can impact a product's quality. GMP guidelines ensure manufacturing processes are clearly defined, critical processes are validated, changes are evaluated, documentation is clear, operators are trained, records are made, distribution minimizes risks, and recalls can be done. The guidelines are enforced by regulatory agencies and aim to produce safe, effective medicines and medical products.
The document summarizes regulatory affairs for the MHRA and USFDA. It discusses the history and roles of the MHRA in regulating clinical trials, licensing products, and enforcing regulations in the UK. It then outlines the development process for new drugs from discovery through licensing. Finally, it provides an introduction to the USFDA, covering its definition, history, mission, organization, functions, and products regulated.
Who guidelines on safety monitoring of natural medicinesPharmacy Slides
This document provides guidelines for monitoring the safety of herbal medicines. It discusses that while some see herbal medicines as inherently safe due to being natural, they can still cause adverse effects. It outlines collecting reports on adverse events from healthcare professionals, consumers, manufacturers, and others. It provides guidance on what herbal products should be monitored and how to report suspected adverse reactions, including requesting information like patient identification and descriptions of the adverse reaction. The goal is to support member states in strengthening pharmacovigilance systems to effectively monitor herbal medicine safety.
Regulatory affairs professionals act as the interface between the pharmaceutical industry and drug regulatory authorities. Their main goals are to protect human health, ensure drug safety and quality, and ensure accurate product information. Key roles include liaising with regulatory agencies, preparing regulatory submissions, and advising on regulatory requirements and guidelines. An investigational new drug (IND) application is filed with regulatory agencies to legally test an experimental drug in humans after preclinical testing. A new drug application (NDA) is filed to obtain approval to market a new drug, while an abbreviated new drug application (ANDA) is filed for generic drug approval based on demonstrating bioequivalence to an existing drug. Drug master files and active substance master files provide confidential manufacturing
The document discusses regulatory bodies and agencies that approve drugs. It provides information on the drug development process and regulatory roles of various agencies around the world such as the FDA in the US and CDSCO in India. It describes the functions of regulatory agencies which include product registration, drug evaluation, monitoring safety and efficacy, and adverse reaction monitoring. The challenges regulatory bodies face in promoting public health and protecting people from harmful drugs are also mentioned.
Pharmacovigilance is the science of monitoring the safety of medicines. It involves detecting, assessing, understanding, and preventing adverse effects of drugs. Pharmacovigilance activities begin during clinical trials and continue throughout a product's lifecycle. The goal of pharmacovigilance is to improve patient safety, public health, and understanding of medication risks and benefits. Careers in pharmacovigilance include roles monitoring adverse events, assessing drug safety, and reviewing medical information to evaluate safety profiles.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
Establishing a herbal drug industry requires navigating complex regulatory requirements related to safety, efficacy, quality and public health. Key aspects include complying with Good Manufacturing Practices, obtaining product licenses by submitting data on safety and efficacy to regulatory authorities, adhering to labeling and packaging guidelines, implementing quality control testing, monitoring adverse events, and ensuring compliance with international standards such as those of the International Conference on Harmonisation. Meeting these regulatory standards contributes to the success, credibility and public health impact of the herbal drug industry.
Understanding the Value of Empathy and Finding Work-Life Balance.pptxHootan Melamed
Hootan Melamed, an inventor and Entrepreneur is from Los Angeles, California. He is motivated to produce things that are valuable to everyone. He enjoys creating and developing products that advance society as a whole.
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This document provides an overview of drug regulatory affairs. It discusses the learning objectives which are to gain knowledge about regulatory processes, laws, and working within a regulatory environment. It defines regulatory affairs as the interface between pharmaceutical companies and drug authorities. The goal is to ensure safety, efficacy and quality of drugs. It discusses some drug tragedies in the past that led to the need for regulatory affairs and authorities like the FDA. Regulatory affairs professionals help companies work within this regulatory system and reduce development failures. Their role is to gather relevant information and assist companies on various regulatory issues from licensing to pharmacovigilance. Major global regulatory authorities are also named.
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This document discusses post-marketing surveillance, outsourcing bioavailability and bioequivalence studies to contract research organizations. It provides an introduction to post-marketing surveillance, describing its role in monitoring drug safety after market approval. A brief history is given of pivotal drug safety issues that led to the establishment of formal post-marketing surveillance systems. Common sources of post-marketing information are also outlined. The document defines outsourcing, bioavailability, bioequivalence, and contract research organizations. It explains how outsourcing is used to reduce costs and improve efficiency through utilizing external partners for certain studies and services.
This document discusses the role and importance of regulatory affairs professionals in the pharmaceutical industry. It notes that regulatory affairs professionals ensure companies comply with relevant laws and regulations, advise on regulatory strategies and requirements, and facilitate the approval and marketing of drugs by communicating with regulatory agencies. Their work is important for developing innovative products and accelerating time to market while ensuring safety, efficacy and compliance.
This document provides information about the 5th Pharmacovigilance Congregation conference taking place on November 20th, 2013 in Mumbai, India. The conference will discuss ensuring safer drugs reach the market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature keynote speakers from various pharmaceutical companies and overviews of the latest challenges and opportunities in pharmacovigilance. The event aims to provide a platform for stakeholders to discuss best practices and advancing pharmacovigilance in India.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
This document provides a summary of common regulatory affairs job interview questions and answers. It begins with defining regulatory affairs and its goals of protecting human health, ensuring drug safety and efficacy, and ensuring accurate product information. It then discusses the roles of regulatory affairs professionals in interacting with regulatory agencies, preparing submissions, and ensuring compliance. The rest of the document provides answers to common interview questions about regulatory submissions, guidelines, authorities, and key concepts and legislation related to drug approval.
Pharmacovigilance Interview Question Part 1ClinosolIndia
"Pharmacovigilance Interview Question Part 1." In this insightful presentation, we delve into the crucial world of pharmacovigilance, exploring fundamental concepts and key questions that play a pivotal role in ensuring drug safety and healthcare integrity.
Embarking on a journey into the intricate realm of drug safety, 'Exploring the Foundations of Pharmacovigilance: Part 1' lays the groundwork for a comprehensive understanding of this crucial field. This segment serves as a gateway to the fundamental principles that underpin pharmacovigilance, unraveling the intricacies of adverse drug reaction monitoring and reporting. Delving into the significance of pharmacovigilance in ensuring patient safety, the exploration encompasses the key concepts and processes that form the backbone of drug safety surveillance. From identifying adverse events to understanding the roles of healthcare professionals and regulatory bodies, 'Part 1' provides a solid foundation for both novices and seasoned professionals alike. As we navigate through this informative chapter, the importance of robust pharmacovigilance practices in the ever-evolving landscape of healthcare becomes increasingly evident, setting the stage for the advanced concepts and global perspectives to follow in subsequent parts of this insightful series.
The document discusses WHO guidelines on rational medicine use and types of irrational medicine use. It notes that more than half of global medicine use is irrational, costing money and reducing treatment effectiveness. Irrational use includes polypharmacy, inappropriate antibiotic use, overuse of injections, and self-medication without prescriptions. The document lists several causes of irrational use, such as the natural history of illnesses, pseudo-logic, advertising influence on prescribers, and the perception that injections are always better than oral medications. Addressing irrational medicine use is important for improving health outcomes and efficient use of resources.
This document discusses quality control and quality assurance for veterinary dosage forms. It begins by defining Good Manufacturing Practices (GMP) which outline the production and testing aspects that can impact a product's quality. GMP guidelines ensure manufacturing processes are clearly defined, critical processes are validated, changes are evaluated, documentation is clear, operators are trained, records are made, distribution minimizes risks, and recalls can be done. The guidelines are enforced by regulatory agencies and aim to produce safe, effective medicines and medical products.
The document summarizes regulatory affairs for the MHRA and USFDA. It discusses the history and roles of the MHRA in regulating clinical trials, licensing products, and enforcing regulations in the UK. It then outlines the development process for new drugs from discovery through licensing. Finally, it provides an introduction to the USFDA, covering its definition, history, mission, organization, functions, and products regulated.
Who guidelines on safety monitoring of natural medicinesPharmacy Slides
This document provides guidelines for monitoring the safety of herbal medicines. It discusses that while some see herbal medicines as inherently safe due to being natural, they can still cause adverse effects. It outlines collecting reports on adverse events from healthcare professionals, consumers, manufacturers, and others. It provides guidance on what herbal products should be monitored and how to report suspected adverse reactions, including requesting information like patient identification and descriptions of the adverse reaction. The goal is to support member states in strengthening pharmacovigilance systems to effectively monitor herbal medicine safety.
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Pharmacovigilance is the science of monitoring the safety of medicines. It involves detecting, assessing, understanding, and preventing adverse effects of drugs. Pharmacovigilance activities begin during clinical trials and continue throughout a product's lifecycle. The goal of pharmacovigilance is to improve patient safety, public health, and understanding of medication risks and benefits. Careers in pharmacovigilance include roles monitoring adverse events, assessing drug safety, and reviewing medical information to evaluate safety profiles.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
Establishing a herbal drug industry requires navigating complex regulatory requirements related to safety, efficacy, quality and public health. Key aspects include complying with Good Manufacturing Practices, obtaining product licenses by submitting data on safety and efficacy to regulatory authorities, adhering to labeling and packaging guidelines, implementing quality control testing, monitoring adverse events, and ensuring compliance with international standards such as those of the International Conference on Harmonisation. Meeting these regulatory standards contributes to the success, credibility and public health impact of the herbal drug industry.
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2. Understanding
pharmaceutical compliance
Pharmaceutical compliance, often known as
pharmaceutical regulatory compliance, is an
essential element of pharmaceuticals. Why?
This is a result of how precise and important
pharmaceutical research is to maintaining
human health. Disobedience may have
negative implications in the pharmaceutical
industry.
3. Pharmaceutical compliance means
that a product complies with all set
criteria and standards. These
standards were created by several
regulatory bodies, both domestically
and internationally.
What does pharma compliance entail?
4. According to Hootan Melamed, the best minds came together to create
these standards in order to create norms that are widely accepted. The
purpose of this rule is to guarantee that products are effective and have
the desired effect.
5. How is compliance achieved in
pharmaceuticals?
The prescribing and execution of
pharmaceutical compliance are the
responsibility of regulatory agencies.
Although various pharmacopoeia (the
science of measuring medical things) are
inescapably needed for many countries, the
fundamental standards are the same
everywhere.
6. WHICH INTERNATIONAL
STANDARDS CONCERN
PHARMACEUTICAL
COMPLIANCE?
International Conference on
Harmonization (ICH), which created a
number of standards, including ICH-
Q7A and ICH Q10, the ISO, standards
needed by the FDA, and national
standards are some of the ones that
are currently in use globally.
WHAT HAPPENS IF DRUG
COMPLIANCE IS ABSENT?
It is obvious what happens when
pharmaceutical training is
skipped. As we have just seen,
disregarding rules set forth by
regulatory bodies can have
serious consequences.
7. A businessman and inventor from Los Angeles is
named Hootan Melamed. He enjoys creating and
designing products that advance society as a
whole. Hootan has created a wide range of goods,
such as Happy Tush (a diaper rash cream), many
drugs, and a hairband for lice (forgetyourlice.com),
and is now working on many more things. Hootan
is always looking for fresh, exciting job
opportunities.