ICH(International Conference on Harmonization) (3).pptx
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The International Conference on Harmonization (ICH) is an organization that brings together regulatory authorities and pharmaceutical industry representatives from Europe, Japan, and the United States to discuss scientific and technical aspects of drug registration. It was established in 1990 to achieve greater consistency in technical guidelines to make the development and availability of new medicines more efficient while maintaining high standards of safety and efficacy. The ICH process involves five steps to build scientific consensus and adopt harmonized guidelines on quality, safety, efficacy, and multidisciplinary topics.
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The document discusses the International Conference on Harmonization (ICH), an organization that aims to harmonize technical requirements for pharmaceutical registration across Europe, Japan, and the United States. It provides an overview of ICH's history, evolution, guidelines, and classification of guidelines. ICH was formed in 1990 to address the rising costs of health care and drug development by reducing redundant testing requirements across regions. Over two decades, ICH has successfully developed guidelines covering quality, efficacy, safety, and multidisciplinary topics to streamline global drug approval processes.
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The document discusses the International Council for Harmonization (ICH), a joint initiative between regulatory authorities and pharmaceutical industries from Europe, Japan, and the US to harmonize technical requirements for pharmaceutical registration. The goals of ICH are to ensure safety, quality and efficacy of medicines, harmonize technical requirements, and develop drugs in an efficient and cost-effective way. ICH has produced numerous guidelines on quality, safety, efficacy and multidisciplinary topics to harmonize regulatory standards across regions.
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The document discusses the International Council for Harmonisation (ICH), which aims to harmonize technical requirements for pharmaceuticals worldwide to ensure safe, effective, and high quality medicines. ICH develops guidelines through a six step process involving regulatory and industry authorities. The guidelines cover topics related to quality, safety, efficacy, and multidisciplinary issues. The general principles that ICH guidelines are based on include stability, analytical validation, impurities, pharmacopeias, quality risk management, and ensuring effective drugs are produced according to recommended standards and shelf lives.
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The document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. It provides an introduction to ICH, the need for harmonization, the origin and evolution of ICH, its objectives and members. It then describes the process of ICH harmonization and provides examples of ICH guidelines related to quality, safety, efficacy, and multidisciplinary topics. The quality guidelines address stability testing, impurities thresholds, and good manufacturing practices.
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ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
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Ich guidlines M. Pharma (DRA IP )
Ich guidlines , OBJECTIVE OF ICH GUIDLINE , QSEM , QUALITY , SAFETY , EFFICACY , MULTIDISLINARY, BENIFIT OF ICH
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intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
Good Clinical Practice
GCP, ICH guide lines, The sponsor, the investigator, define gcp, outline principles of gcp, players involved in gcp,
ICH
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International council for harmonisation (ich) guidelines
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ICH ....
The International Conference on Harmonization (ICH) was launched 20 years ago to bring together drug regulatory authorities and pharmaceutical industry representatives from Europe, Japan, and the United States to discuss harmonizing technical requirements for pharmaceutical product registration. ICH aims to reduce duplication of testing and develop unified guidelines through a consensus-based approach. Key topics of harmonization include safety, quality, and efficacy. ICH guidelines are recognized as the global standards for the regulation of pharmaceuticals.
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The document discusses the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. It provides an introduction to ICH, the need for harmonization, the origin and evolution of ICH, its objectives and members. It then describes the process of ICH harmonization and provides examples of ICH guidelines related to quality, safety, efficacy, and multidisciplinary topics. The quality guidelines address stability testing, impurities thresholds, and good manufacturing practices.
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ICH -International Council for Harmonization overview , organizational chart and guidelines including photos , websites and insider infos, including members with their native regions...
ICH GUIDELINE IN PHARMACY
The International Council for Harmonization (ICH) brings together regulatory authorities and the pharmaceutical industry from Europe, Japan, and the US to discuss scientific and technical aspects of drug registration. ICH aims to harmonize technical requirements for registration to reduce duplication of testing and help ensure safe, effective, and high quality medicines are developed efficiently. ICH has published guidelines on quality, safety, efficacy, and multidisciplinary topics related to manufacturing, nonclinical studies, clinical trials, and electronic standards.
ICH introduction.pptx
The International Conference on Harmonization (ICH) aims to harmonize technical requirements for pharmaceutical registration across regions to increase consistency, make more efficient use of resources, and help develop and make more medicines available while maintaining quality and efficacy. ICH seeks to standardize guidelines and requirements for drug registration to reduce costs and better meet public health needs. Its objectives include achieving greater consistency in technical guidelines, more economical use of human and material resources, and facilitating more drug development and availability with safeguards for quality and effectiveness.
ICH goals and process.pptx
The document discusses the goals and process of the International Conference on Harmonization (ICH). The ICH aims to harmonize technical requirements for pharmaceutical registration across regions to increase efficiency and access to new medicines while maintaining quality and safety. The ICH process involves developing guidelines through formal procedures, answering questions, revising existing guidelines, and maintaining established standards.
Introduction to ICH.pptx
The document introduces the International Conference on Harmonization (ICH), which aims to harmonize technical requirements for pharmaceutical registration across regions to increase consistency, make more efficient use of resources, and help develop new medicines while maintaining safety and effectiveness. ICH seeks to standardize guidelines and registration processes for drugs to reduce costs and better meet public health needs.
ICH GCP guidelines
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ICH Introduction
The International Conference on Harmonization (ICH) is a joint regulatory/industry initiative involving drug regulatory authorities and pharmaceutical industry in the European Union, Japan, and the United States. The goal of ICH is to harmonize technical requirements for pharmaceutical product registration among these three regions to ensure safety and efficacy and allow for more efficient drug development. ICH develops harmonized guidelines covering non-clinical, clinical, and quality topics through expert working groups with representatives from regulatory agencies and industry.
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Ich guidlines , OBJECTIVE OF ICH GUIDLINE , QSEM , QUALITY , SAFETY , EFFICACY , MULTIDISLINARY, BENIFIT OF ICH
International council for harmonization by akshay trivedi
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
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The International Council for Harmonisation (ICH) is a joint regulatory-industry initiative to harmonize technical requirements for pharmaceutical product registration. It aims to reduce duplication of testing by achieving greater harmonization in guidelines' interpretation between Europe, Japan, and the United States. ICH addresses safety, quality, efficacy, and other topics through guidelines developed by expert working groups representing regulators and industry. Over two decades, ICH has successfully harmonized guidelines through scientific consensus.
International council for harmonisation (ich) guidelines
The document discusses the International Council for Harmonisation (ICH) guidelines. It provides definitions for ICH as a joint initiative between regulators and industry in the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. The objectives of ICH are outlined as increasing harmonization to ensure safe, effective, and high quality medicines are developed efficiently. The organizational structure and processes of ICH are described, including its steering committee, working groups, and 5 step guideline development process. An overview is provided of the various ICH guidelines categories including quality, safety, efficacy, and multidisciplinary guidelines. Specific stability testing guidelines are also briefly discussed.
Ich – guidelines
The document provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses ICH's mission to harmonize pharmaceutical guidelines and regulations across regions to ensure safe, effective and high quality medicines. Key points covered include ICH's history and members, as well as descriptions of ICH's organization, process for guideline development, and several quality, safety, efficacy and multidisciplinary guidelines.
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Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
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- 1. ICH(International Conference on Harmonization) Prepared by Kashish Wilson Assistant Professor MM(DU)Mullana Ambala
- 2. What is ICH?????? • "International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use". Regulatory agencies + Industrial Association (EU, Japan & USA) SCIENTIFIC AND TECHNICAL CONSENSUS
- 3. Initiation of ICH • pioneered by the European Community (EC), in the 1980s • at the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989 • authorities approached IFPMA • The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels.
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- 10. THANKS