The two presentations in the video offer clear explanations of how the OECD Test Guidelines Programme operates, the key actors and partners. The second presentation illustrates how a validation body has been actively contributing to the Programme. A number of challenges are also identified moving forward with new approach methods.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The document discusses principles and guidelines regarding the use of animals in research experiments. It summarizes key points from international guidelines developed in 1985 by CIOMS and endorsed by WHO and EMRC. The principles emphasize replacing animal experiments where possible, using the minimum number of animals required, avoiding pain and distress, proper housing and care of animals, and ensuring researchers are qualified to conduct procedures on animals. It also discusses investigator responsibilities to apply the Three Rs (Replacement, Reduction and Refinement) and keep detailed records of animal experiments.
The document provides information about the Organization for Economic Co-operation and Development (OECD). It discusses the history and establishment of the OECD, its objectives to promote policies that improve economic and social well-being, and how it provides a forum for governments to work together on issues like economic growth, employment, financial stability, and trade. The document also summarizes OECD's toxicity testing guidelines, which provide standardized methods for testing chemicals and their potential hazards. This allows data to be shared between countries and avoids duplicative testing.
Research Methods: Ethics II (Animal Research)Brian Piper
lecture 3 from a college level research methods in psychology course taught in the spring 2012 semester by Brian J. Piper, Ph.D. (psy391@gmail.com) at Linfield College, includes IACUC, animal welfare act, refinement, reduction, replacement
The document summarizes the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The ICH was established in 1990 and brings together regulatory authorities and the pharmaceutical industry from Europe, Japan, and the United States to discuss product registration and improve efficiency. The ICH has developed over 50 harmonized guidelines on quality, safety, efficacy, and other topics to eliminate duplication in the drug development and approval process. The guidelines cover areas like stability testing, analytical validation methods, impurities, biotechnological products, and good manufacturing practices.
This document discusses alternative in vitro test methods that can potentially replace animal tests for assessing eye and skin irritation. It provides background on the development of alternative methods and validation process. Two alternative eye irritation tests - Bovine Corneal Opacity and Permeability Assay and Isolated Chicken Eye Assay - have been validated and accepted by OECD for regulatory use. Reconstructed human epidermis models EpiDerm and EpiSkin have also been validated and accepted to classify chemicals for skin irritation hazard. The document outlines several alternative assay methods and their limitations but emphasizes the scientific push for non-animal tests due to ethical concerns and limitations of animal models.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The document discusses principles and guidelines regarding the use of animals in research experiments. It summarizes key points from international guidelines developed in 1985 by CIOMS and endorsed by WHO and EMRC. The principles emphasize replacing animal experiments where possible, using the minimum number of animals required, avoiding pain and distress, proper housing and care of animals, and ensuring researchers are qualified to conduct procedures on animals. It also discusses investigator responsibilities to apply the Three Rs (Replacement, Reduction and Refinement) and keep detailed records of animal experiments.
The document provides information about the Organization for Economic Co-operation and Development (OECD). It discusses the history and establishment of the OECD, its objectives to promote policies that improve economic and social well-being, and how it provides a forum for governments to work together on issues like economic growth, employment, financial stability, and trade. The document also summarizes OECD's toxicity testing guidelines, which provide standardized methods for testing chemicals and their potential hazards. This allows data to be shared between countries and avoids duplicative testing.
Research Methods: Ethics II (Animal Research)Brian Piper
lecture 3 from a college level research methods in psychology course taught in the spring 2012 semester by Brian J. Piper, Ph.D. (psy391@gmail.com) at Linfield College, includes IACUC, animal welfare act, refinement, reduction, replacement
The document summarizes the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The ICH was established in 1990 and brings together regulatory authorities and the pharmaceutical industry from Europe, Japan, and the United States to discuss product registration and improve efficiency. The ICH has developed over 50 harmonized guidelines on quality, safety, efficacy, and other topics to eliminate duplication in the drug development and approval process. The guidelines cover areas like stability testing, analytical validation methods, impurities, biotechnological products, and good manufacturing practices.
This document discusses alternative in vitro test methods that can potentially replace animal tests for assessing eye and skin irritation. It provides background on the development of alternative methods and validation process. Two alternative eye irritation tests - Bovine Corneal Opacity and Permeability Assay and Isolated Chicken Eye Assay - have been validated and accepted by OECD for regulatory use. Reconstructed human epidermis models EpiDerm and EpiSkin have also been validated and accepted to classify chemicals for skin irritation hazard. The document outlines several alternative assay methods and their limitations but emphasizes the scientific push for non-animal tests due to ethical concerns and limitations of animal models.
This guideline was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. This guideline provides a definition, general principles and recommendations for safety pharmacology studies
This document outlines the OECD guidelines for carcinogenicity testing. It discusses the objectives of carcinogenicity studies which include identifying carcinogenic properties, target organs, time to appearance of neoplasms, and establishing a no-observed-adverse-effect level. It describes the typical procedure which involves administering the test substance daily to rodents and observing them for signs of toxicity and tumor development. Key aspects covered are test animals, dose levels, duration of study, observations, pathology examination, and reporting of results and test conditions.
The Common Technical Document (CTD) format was officially adopted in November 2000 at the 5th International Conference on Harmonisation (ICH) in San Diego, California. The CTD format was a joint effort between the European Medicines Agency, Food and Drug Administration, and Ministry of Health, Labour and Welfare. It structures technical data for drug submissions into common modules to facilitate simultaneous review across different regions and reduce resources needed for duplicate submissions. After implementation, the CTD format helped harmonize submission requirements and allowed for faster drug approvals globally.
This document discusses the druggability of new chemical entities (NCEs). It defines druggability as the ability of a compound to be used commercially as a pharmaceutical drug after undergoing clinical trials. Several rules for determining druggability are described, with Lipinski's rule of five being the most popular. Lipinski's rule states that good oral bioavailability is more likely if a compound has less than 5 H-bond donors, 10 H-bond acceptors, a molecular weight below 500 Daltons, and a logP value below 5. The document also discusses other druggability rules and exceptions to Lipinski's rule.
This document discusses genotoxic impurities and their analysis. It defines different types of DNA damage including single-base alterations, two-base alterations, chain breaks, and cross-linkages. It also discusses types of genetic damage such as mutagenic, senescence, apoptosis, and clastogenic effects. The document reviews ICH guidelines on impurities and how subsequent guidelines addressed genotoxic impurities. It outlines the process for assessing impurities based on ICH M7, including classifying impurities, identifying alerting structures, and using structure-activity relationships or the Ames test. Detection techniques for impurities including ICP-MS and ICP-AES are also summarized.
Data Privacy and Security in Clinical Trials: Safeguarding Patient InformationClinosolIndia
Data privacy and security in clinical trials are critical to safeguard patient information and ensure compliance with relevant regulations, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in the European Union.
Georgina Gal, Regulatory Affairs Manager, AbbVie, Hungary
Presentation at EIPG – BIPA Symposium “Clinical Trials Research” at the Faculty of Pharmacy, Medical University of Sofia, Sofia 2014.
The document summarizes guidelines from the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) for conducting experiments on animals in India. Some key points:
- CPCSEA is a statutory body formed in 1964 to regulate experimentation on animals and ensure their humane treatment.
- Its objectives include promoting animal welfare, improving laboratory facilities, and enhancing biological knowledge relevant to humans and animals.
- Guidelines cover registration requirements, facility standards, animal housing and care protocols, veterinary support, and compliance monitoring. Experiments must adhere to the "Five R's" of replacement, reduction, refinement, rehabilitation, and reuse.
- Proper facilities, environmental conditions,
The document discusses guidelines for forced degradation studies to develop stability-indicating methods. Key points include:
1) Forced degradation studies subject drug substances, products, and placebos to stress conditions like heat, humidity, acids, bases, oxidation, and light to understand degradation pathways and develop suitable methods.
2) Common stress tests include thermal, hydrolytic, oxidative, and photolytic degradation. Conditions are specified for each test.
3) Potential degradation products are identified and the method is evaluated based on peak purity, mass balance, and other criteria.
4) Guidelines are provided for establishing relative response factors, quantitation methods, and system suitability parameters based on forced degradation results.
Initial considerations for the study design include information on the test chemical's identity, properties, and results from previous toxicity tests. The guideline describes conducting a chronic toxicity study in rodents for 12 months, with the potential for interim kills and satellite groups. Key steps include dosing animals daily, observing them for signs of toxicity, and conducting clinical pathology, including hematology, clinical biochemistry, and urinalysis at various times. At the end, a full gross necropsy is performed and tissues are examined microscopically. Results are reported individually and summarized, including survival, body weights, food consumption, toxic responses, organ weights, and histopathological findings.
The Anatomical Therapeutic Chemical (ATC) classification system is a standardized system for classifying drugs and other medical substances. The system is maintained by the World Health Organization (WHO) and is used globally for drug classification and coding purposes.
The ATC classification system is based on the anatomical, therapeutic, and chemical properties of the drug, which helps to identify drugs based on their active ingredients and their therapeutic uses. The system consists of seven alphanumeric levels, with each level representing a different aspect of the drug classification.
The first level of the ATC code consists of the anatomical main group, which is based on the organ or system on which the drug acts. The second level consists of the therapeutic subgroup, which describes the therapeutic use of the drug. The third level consists of the pharmacological subgroup, which describes the mode of action of the drug. The fourth level consists of the chemical subgroup, which describes the chemical structure of the drug. The fifth level is the specific chemical substance, which identifies the active ingredient of the drug. The sixth level is the preparation, which describes the formulation of the drug. The seventh and final level is the packaging, which describes the packaging and administration of the drug.
ATC codes are used for many purposes, including drug registration, reimbursement, and drug utilization studies. The use of a standardized coding system like the ATC classification system helps to ensure consistency and accuracy in drug classification and coding, making it easier to compare and analyze drug utilization data across different regions and countries.
Overview of OECD Test Guidelines for Thyroid EffectsOECD Environment
The document provides an overview of the OECD Test Guidelines for assessing thyroid effects. It describes a five-level framework for endocrine toxicity testing that includes in vitro, in vivo, and adverse effect assays. Several guidelines contain thyroid-related endpoints, including the Amphibian Metamorphosis Assay (hindlimb length, development stage, thyroid histology), 21-day Fish Assay (thyroid histology), Repeated Dose studies (thyroid histology, T3/T4), and Extended One Generation Reproductive Toxicity Study (T4/TSH, thyroid weight). The document indicates that some guidelines could be updated to better include thyroid measurements.
Working with Argus Safety in a Global CommunityPerficient
Argus is a pharmacovigilance software that supports global safety management through flexible configuration, integrated workflow and reporting features. It allows cases to be entered locally and sent to a central repository for review. Argus facilitates global case processing and labeling through worklists and notification tools. Reports can be generated in local languages to aid review and regulatory submission tracking in different countries.
The document summarizes guidelines from various organizations regarding the use of animals in research and experiments, including CPCSEA, ICMR, and INSA. It outlines standards for veterinary care, housing and facilities, disease prevention and treatment, record keeping, anesthesia, euthanasia, and other procedures to ensure the humane treatment of laboratory animals and that unnecessary pain or suffering is avoided. The guidelines are intended to properly oversee and regulate experimentation on animals.
This presentation provides a knowledge about Toxicology, its types , definition, regulatory guidelines for conducting toxicological studies, OECD guidelines for GLP. This is an assignment in the subject, Pharmacological & Toxicological Screening Methods - II, 2nd Semester, M.Pharm (Pharmacology)
This document discusses the history and types of animal experimentation. It notes that Aristotle and Erasistratus were among the first to use living animals in experiments. It outlines the types of animal research including basic research, applied research, toxicology testing, and xenotransplantation. Common animal models used are rats, mice, rabbits, and guinea pigs. The document also discusses the principles of replacement, reduction and refinement of animal experiments and the ethical requirements for conducting such research.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
Hand book of good clinical research practicePTCnetwork
This document provides an introduction and overview of Good Clinical Practice (GCP) guidelines. GCP provides standards for clinical research involving human subjects to ensure ethical and scientific quality. Compliance with GCP protects subjects' rights and safety while ensuring research integrity. GCP responsibilities are shared by all involved parties. The guidelines aim to help national authorities, sponsors, investigators and ethics committees properly implement GCP for clinical trials.
This document provides an overview of Good Laboratory Practice (GLP) principles established by the Organization for Economic Co-operation and Development (OECD). It discusses the key personnel involved in GLP studies including study directors, quality assurance personnel, and principal investigators. Facilities, equipment, test systems, standard operating procedures, study plans, and conduct of studies are also summarized in relation to adhering to GLP principles. The goal of GLP is to promote quality and validity of safety testing data for chemicals and products.
The document discusses OECD's Mutual Acceptance of Data (MAD) system, which aims to avoid duplicative testing of chemicals by industry and reduce non-tariff trade barriers. Under MAD, toxicological and ecotoxicological data generated in OECD countries in accordance with OECD Test Guidelines and Good Laboratory Practice principles must be accepted by other OECD members for regulatory purposes. Approximately 160 Test Guidelines cover various endpoints. Guidelines are regularly updated to meet regulatory needs. MAD is estimated to result in over 300 million euros in annual net savings through eliminating redundant testing.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
This guideline was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. This guideline provides a definition, general principles and recommendations for safety pharmacology studies
This document outlines the OECD guidelines for carcinogenicity testing. It discusses the objectives of carcinogenicity studies which include identifying carcinogenic properties, target organs, time to appearance of neoplasms, and establishing a no-observed-adverse-effect level. It describes the typical procedure which involves administering the test substance daily to rodents and observing them for signs of toxicity and tumor development. Key aspects covered are test animals, dose levels, duration of study, observations, pathology examination, and reporting of results and test conditions.
The Common Technical Document (CTD) format was officially adopted in November 2000 at the 5th International Conference on Harmonisation (ICH) in San Diego, California. The CTD format was a joint effort between the European Medicines Agency, Food and Drug Administration, and Ministry of Health, Labour and Welfare. It structures technical data for drug submissions into common modules to facilitate simultaneous review across different regions and reduce resources needed for duplicate submissions. After implementation, the CTD format helped harmonize submission requirements and allowed for faster drug approvals globally.
This document discusses the druggability of new chemical entities (NCEs). It defines druggability as the ability of a compound to be used commercially as a pharmaceutical drug after undergoing clinical trials. Several rules for determining druggability are described, with Lipinski's rule of five being the most popular. Lipinski's rule states that good oral bioavailability is more likely if a compound has less than 5 H-bond donors, 10 H-bond acceptors, a molecular weight below 500 Daltons, and a logP value below 5. The document also discusses other druggability rules and exceptions to Lipinski's rule.
This document discusses genotoxic impurities and their analysis. It defines different types of DNA damage including single-base alterations, two-base alterations, chain breaks, and cross-linkages. It also discusses types of genetic damage such as mutagenic, senescence, apoptosis, and clastogenic effects. The document reviews ICH guidelines on impurities and how subsequent guidelines addressed genotoxic impurities. It outlines the process for assessing impurities based on ICH M7, including classifying impurities, identifying alerting structures, and using structure-activity relationships or the Ames test. Detection techniques for impurities including ICP-MS and ICP-AES are also summarized.
Data Privacy and Security in Clinical Trials: Safeguarding Patient InformationClinosolIndia
Data privacy and security in clinical trials are critical to safeguard patient information and ensure compliance with relevant regulations, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in the European Union.
Georgina Gal, Regulatory Affairs Manager, AbbVie, Hungary
Presentation at EIPG – BIPA Symposium “Clinical Trials Research” at the Faculty of Pharmacy, Medical University of Sofia, Sofia 2014.
The document summarizes guidelines from the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) for conducting experiments on animals in India. Some key points:
- CPCSEA is a statutory body formed in 1964 to regulate experimentation on animals and ensure their humane treatment.
- Its objectives include promoting animal welfare, improving laboratory facilities, and enhancing biological knowledge relevant to humans and animals.
- Guidelines cover registration requirements, facility standards, animal housing and care protocols, veterinary support, and compliance monitoring. Experiments must adhere to the "Five R's" of replacement, reduction, refinement, rehabilitation, and reuse.
- Proper facilities, environmental conditions,
The document discusses guidelines for forced degradation studies to develop stability-indicating methods. Key points include:
1) Forced degradation studies subject drug substances, products, and placebos to stress conditions like heat, humidity, acids, bases, oxidation, and light to understand degradation pathways and develop suitable methods.
2) Common stress tests include thermal, hydrolytic, oxidative, and photolytic degradation. Conditions are specified for each test.
3) Potential degradation products are identified and the method is evaluated based on peak purity, mass balance, and other criteria.
4) Guidelines are provided for establishing relative response factors, quantitation methods, and system suitability parameters based on forced degradation results.
Initial considerations for the study design include information on the test chemical's identity, properties, and results from previous toxicity tests. The guideline describes conducting a chronic toxicity study in rodents for 12 months, with the potential for interim kills and satellite groups. Key steps include dosing animals daily, observing them for signs of toxicity, and conducting clinical pathology, including hematology, clinical biochemistry, and urinalysis at various times. At the end, a full gross necropsy is performed and tissues are examined microscopically. Results are reported individually and summarized, including survival, body weights, food consumption, toxic responses, organ weights, and histopathological findings.
The Anatomical Therapeutic Chemical (ATC) classification system is a standardized system for classifying drugs and other medical substances. The system is maintained by the World Health Organization (WHO) and is used globally for drug classification and coding purposes.
The ATC classification system is based on the anatomical, therapeutic, and chemical properties of the drug, which helps to identify drugs based on their active ingredients and their therapeutic uses. The system consists of seven alphanumeric levels, with each level representing a different aspect of the drug classification.
The first level of the ATC code consists of the anatomical main group, which is based on the organ or system on which the drug acts. The second level consists of the therapeutic subgroup, which describes the therapeutic use of the drug. The third level consists of the pharmacological subgroup, which describes the mode of action of the drug. The fourth level consists of the chemical subgroup, which describes the chemical structure of the drug. The fifth level is the specific chemical substance, which identifies the active ingredient of the drug. The sixth level is the preparation, which describes the formulation of the drug. The seventh and final level is the packaging, which describes the packaging and administration of the drug.
ATC codes are used for many purposes, including drug registration, reimbursement, and drug utilization studies. The use of a standardized coding system like the ATC classification system helps to ensure consistency and accuracy in drug classification and coding, making it easier to compare and analyze drug utilization data across different regions and countries.
Overview of OECD Test Guidelines for Thyroid EffectsOECD Environment
The document provides an overview of the OECD Test Guidelines for assessing thyroid effects. It describes a five-level framework for endocrine toxicity testing that includes in vitro, in vivo, and adverse effect assays. Several guidelines contain thyroid-related endpoints, including the Amphibian Metamorphosis Assay (hindlimb length, development stage, thyroid histology), 21-day Fish Assay (thyroid histology), Repeated Dose studies (thyroid histology, T3/T4), and Extended One Generation Reproductive Toxicity Study (T4/TSH, thyroid weight). The document indicates that some guidelines could be updated to better include thyroid measurements.
Working with Argus Safety in a Global CommunityPerficient
Argus is a pharmacovigilance software that supports global safety management through flexible configuration, integrated workflow and reporting features. It allows cases to be entered locally and sent to a central repository for review. Argus facilitates global case processing and labeling through worklists and notification tools. Reports can be generated in local languages to aid review and regulatory submission tracking in different countries.
The document summarizes guidelines from various organizations regarding the use of animals in research and experiments, including CPCSEA, ICMR, and INSA. It outlines standards for veterinary care, housing and facilities, disease prevention and treatment, record keeping, anesthesia, euthanasia, and other procedures to ensure the humane treatment of laboratory animals and that unnecessary pain or suffering is avoided. The guidelines are intended to properly oversee and regulate experimentation on animals.
This presentation provides a knowledge about Toxicology, its types , definition, regulatory guidelines for conducting toxicological studies, OECD guidelines for GLP. This is an assignment in the subject, Pharmacological & Toxicological Screening Methods - II, 2nd Semester, M.Pharm (Pharmacology)
This document discusses the history and types of animal experimentation. It notes that Aristotle and Erasistratus were among the first to use living animals in experiments. It outlines the types of animal research including basic research, applied research, toxicology testing, and xenotransplantation. Common animal models used are rats, mice, rabbits, and guinea pigs. The document also discusses the principles of replacement, reduction and refinement of animal experiments and the ethical requirements for conducting such research.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
Hand book of good clinical research practicePTCnetwork
This document provides an introduction and overview of Good Clinical Practice (GCP) guidelines. GCP provides standards for clinical research involving human subjects to ensure ethical and scientific quality. Compliance with GCP protects subjects' rights and safety while ensuring research integrity. GCP responsibilities are shared by all involved parties. The guidelines aim to help national authorities, sponsors, investigators and ethics committees properly implement GCP for clinical trials.
This document provides an overview of Good Laboratory Practice (GLP) principles established by the Organization for Economic Co-operation and Development (OECD). It discusses the key personnel involved in GLP studies including study directors, quality assurance personnel, and principal investigators. Facilities, equipment, test systems, standard operating procedures, study plans, and conduct of studies are also summarized in relation to adhering to GLP principles. The goal of GLP is to promote quality and validity of safety testing data for chemicals and products.
The document discusses OECD's Mutual Acceptance of Data (MAD) system, which aims to avoid duplicative testing of chemicals by industry and reduce non-tariff trade barriers. Under MAD, toxicological and ecotoxicological data generated in OECD countries in accordance with OECD Test Guidelines and Good Laboratory Practice principles must be accepted by other OECD members for regulatory purposes. Approximately 160 Test Guidelines cover various endpoints. Guidelines are regularly updated to meet regulatory needs. MAD is estimated to result in over 300 million euros in annual net savings through eliminating redundant testing.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
This document provides an overview of the International Conference on Harmonization (ICH) which brings together regulatory authorities from Europe, Japan, and the US to discuss scientific and technical requirements for pharmaceutical products. The objectives of ICH are to reduce costs by harmonizing legislative and technical requirements and reducing duplicative research, as well as to reduce the time needed for global drug marketing approval. ICH guidelines are developed through a 5-step process and cover topics related to pharmaceutical quality, efficacy, safety, and multidisciplinary issues.
Oecd principles of good laboratory practices (glp)Sriram Mamidi
The document discusses the OECD Principles of Good Laboratory Practice (GLP). It begins with an introduction to GLP and why it was created due to issues of poor laboratory practices discovered by the FDA in the 1970s. It then discusses the scope and principles of GLP established by the OECD, including test facility organization, quality assurance programs, facilities, equipment and materials, test systems, test and reference items, standard operating procedures, study conduct, reporting and storage. The principles are intended to ensure safety data from nonclinical studies are reliable and of high quality.
Presentation: Developing Science-Informed Policy Responses to Curb Endocrine...OECD Environment
Presentation: Developing Science-Informed Policy Responses to Curb Endocrine Disruption in Freshwater, Valeria Dulio - Executive Secretary of the NORMAN Association, INERIS - Direction Milieu et Impacts sur le Vivant
OECD Green Talks LIVE: Global eChemPortal to information on chemical substancesOECD Environment
To meet public health and environmental objectives for the safe use of chemicals under proper conditions, increasing understanding of chemical hazards and risks is key. By increasing access to data and information, governments and industry can work to reduce – or even eliminate – adverse health effects from exposures to chemicals.
The OECD eChemPortal provides direct access to critical scientific information on chemical substances of regulatory relevance with over 800,000 substance records from 37 databases. The portal allows countries and companies to share work, ensure resource efficiencies, and, subsequently, reduce animal testing.
Gerlinde Knetch (Germany), Jake Sanderson (Canada) and Violaine Verougstraete from Eurometaux shared their experience in improving chemical safety and how the eChemPortal supported this process.
New Developments in External Quality Assurance in the EHEAColin Tück
This document discusses new developments in external quality assurance in the European Higher Education Area. It covers the following topics:
1. An overview of the European Quality Assurance Register for Higher Education (EQAR) which registers quality assurance agencies that comply with European standards.
2. A project examining cross-border quality assurance and the degree to which countries allow international quality assurance agencies to operate within their systems.
3. An ongoing revision of the European Standards and Guidelines for quality assurance to update and clarify the standards.
4. A proposal for a European approach to quality assurance of joint academic programs, focusing on single, integrated reviews based on European standards rather than additional national criteria.
Building trust through improved tools and practice in the life cycle of mecha...OECD Environment
This document discusses improving the use of academic data in regulatory assessments by addressing issues related to how the data is generated, documented, retrieved, and evaluated. It proposes developing guidance to help researchers better design and report studies to facilitate regulatory uptake. It also suggests creating a search guide to help assessors find, access, and evaluate academic data from scientific sources by building on existing tools and repositories. This would help implement the requirement to consider all available information in assessments.
OECD principles of Good laboratory practice. this ppt include the basic and necessary information required for OECD GLP guideline . Content is taken from official site
'Open stakeholder meeting on mHealth assessment guidelines'
presentation of the guidelines by Andrew Ruck and Charles Lowe.
For more information visit:
https://ec.europa.eu/digital-single-market/en/news/open-stakeholder-meeting-mhealth-assessment-guidelines-presentations-and-survey
Wolfgang Reinert - Guidance on guidance document developmentcropprotection
This document outlines a proposed guidance on developing guidance documents. It would define the process for creating and revising guidance documents, including establishing competencies, drafting steps, adoption procedures, and application dates. The guidance aims to improve quality, usefulness, and transparency by clarifying roles, avoiding duplication, and communicating the process to authorities and stakeholders. A stepwise approach is recommended that identifies needs, produces concept papers, allows for discussion and adoption, and publishes the final documents.
The world of Regulatory convergence: an Australian reflectionTGA Australia
This presentation provides an overview on recent advances and initiatives on regulatory convergence and the impact on Australian, European and international regulation of therapeutic goods.
GOOD LABORATORY PRACTICE by ILyas Mphil student.pptxAtaUrRahman50751
This document discusses Good Laboratory Practice (GLP) guidelines. It was prepared by Ilyas Ahamd and Siyar Khan, who are M.Phil scholars. GLP provides a framework for planning, conducting, monitoring, recording, reporting and archiving laboratory studies to ensure the safety of users, consumers and the environment. Key aspects of GLP include qualified personnel, validated equipment and methods, standard operating procedures, accurate documentation and record keeping, quality assurance programs, and facility organization and management. GLP aims to ensure data integrity and that results submitted to regulatory agencies accurately reflect what was found in studies.
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.
Presented at the 4th Global Animal Health Conference 2015 #GAHC2015 on Regulatory Convergence. Held in Dar Es Salaam, Tanzania, 24-25 June 2015.
This was presented by GALVmed consultant Gilly Cowan and discussed GALVmed's progress in following up the recommendations from the 2010 Global Animal Health Conference when African regulators asked for a harmonised registration system, mutual recognition and training for their regulators in the registration of veterinary vaccines.
GALVmed, the Global Alliance for Livestock Veterinary Medicines, works through its partners to protect livestock and improve human lives by making livestock vaccines, diagnostics & medicines accessible and affordable to the millions of those who rely on livestock.
For more information on this conference, hosted by Health For Animals (formerly IFAH), visit here: http://healthforanimals.org/global-animal-health-conference-addresses-regulatory-barriers/
To read more highlights from the conference, click here: https://twitter.com/hashtag/GAHC2015?src=hash
The fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies.
Similar to A better understanding of the OECD Test Guidelines Programme and the validation principles in action (20)
OECD Green Talks LIVE | Diving deeper: the evolving landscape for assessing w...OECD Environment
Water is critical for meeting commitments of the Paris Agreement and achieving the Sustainable Development Goals. Our economies rely on water, with recent estimates putting the economic value of water and freshwater ecosystems at USD 58 trillion - equivalent to 60% of global GDP. At the same time, water related risks are increasing in frequency and scale in the context of climate change.
How are investments shaping our economies and societies exposure to water risk? What role can the financial system play in supporting water security? And how can increased understanding of how finance both impacts and depends on water resources spur action towards greater water security?
This OECD Green Talks LIVE on Tuesday 14 May 2024 from 15:00 to 16:00 CEST discussed the evolving landscape for assessing water risks to the financial system.
OECD Policy Analyst Lylah Davies presented key findings and recommendations from recent OECD work on assessing the financial materiality of water-related risks, including the recently published paper “Watered down? Investigating the financial materiality of water-related risks” and was joined by experts to discuss relevant initiatives underway.
Detlef Van Vuuren- Integrated modelling for interrelated crises.pdfOECD Environment
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
Thomas Hertel- Integrated Policies for the Triple Planetary Crisis.pdfOECD Environment
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
Jon Sampedro - Assessing synergies and trade offs for health and sustainable ...OECD Environment
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
Astrid Bos - Identifying trade offs & searching for synergies.pdfOECD Environment
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
Ruth Delzeit - Modelling environmental and socio-economic impacts of cropland...OECD Environment
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
Wilfried Winiwarter - Implementing nitrogen pollution control pathways in the...OECD Environment
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
Laurent Drouet - Physical and Economic Risks of Climate Change.pdfOECD Environment
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
This OECD technical workshop will bring together leading experts on economic, biophysical, and integrated assessment modelling of the interactions between climate change, biodiversity loss, and pollution. The workshop will take stock of ongoing modelling efforts to develop quantitative pathways to study the drivers and impacts of the triple planetary crisis, and the policies to address it. The aim is to identify robust modelling approaches to inform the work for the upcoming OECD Environmental Outlook.
HyeJin Kim and Simon Smart - The biodiversity nexus across multiple drivers: ...OECD Environment
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Case Study: Peptides-based Plant Protection Product (harpin proteins*) by Ros...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
CLE Contribution on the Assessment of Innovative Biochemicals in the EU Statu...OECD Environment
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The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
Additional Considerations for Pesticide Formulations Containing Microbial Pes...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
Role of genome sequencing (WGS) in microbial biopesticides safety assessment ...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
Considerations for Problem Formulation for Human Health Safety Assessments of...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
How to Identify and Quantify Mixtures What is Essential to Know for Risk Asse...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
APVMA outcome-focussed approach to data requirements to support registration ...OECD Environment
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The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
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The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
Problem formulation for environmental risk assessment – Finnish case study: ...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
Epcon is One of the World's leading Manufacturing Companies.EpconLP
Epcon is One of the World's leading Manufacturing Companies. With over 4000 installations worldwide, EPCON has been pioneering new techniques since 1977 that have become industry standards now. Founded in 1977, Epcon has grown from a one-man operation to a global leader in developing and manufacturing innovative air pollution control technology and industrial heating equipment.
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Results of geophysics and pneumatic injection pilot tests during 2003 – 2007 yielded significant positive results for injection delivery design and contaminant mass treatment, resulting in permanent shut-down of an existing groundwater Pump & Treat system.
Accessible source areas were subsequently removed (2011) by soil excavation and treated with the placement of Emulsified Vegetable Oil EVO and zero-valent iron ZVI to accelerate treatment of impacted groundwater in overburden and weathered fractured bedrock. Post pilot test and post remediation groundwater monitoring has included analyses of CVOCs, organic fatty acids, dissolved gases and QuantArray® -Chlor to quantify key microorganisms (e.g., Dehalococcoides, Dehalobacter, etc.) and functional genes (e.g., vinyl chloride reductase, methane monooxygenase, etc.) to assess potential for reductive dechlorination and aerobic cometabolism of CVOCs.
In 2022, the first commercial application of MetaArray™ was performed at the site. MetaArray™ utilizes statistical analysis, such as principal component analysis and multivariate analysis to provide evidence that reductive dechlorination is active or even that it is slowing. This creates actionable data allowing users to save money by making important site management decisions earlier.
The results of the MetaArray™ analysis’ support vector machine (SVM) identified groundwater monitoring wells with a 80% confidence that were characterized as either Limited for Reductive Decholorination or had a High Reductive Reduction Dechlorination potential. The results of MetaArray™ will be used to further optimize the site’s post remediation monitoring program for monitored natural attenuation.
Climate Change All over the World .pptxsairaanwer024
Climate change refers to significant and lasting changes in the average weather patterns over periods ranging from decades to millions of years. It encompasses both global warming driven by human emissions of greenhouse gases and the resulting large-scale shifts in weather patterns. While climate change is a natural phenomenon, human activities, particularly since the Industrial Revolution, have accelerated its pace and intensity
Microbial characterisation and identification, and potability of River Kuywa ...Open Access Research Paper
Water contamination is one of the major causes of water borne diseases worldwide. In Kenya, approximately 43% of people lack access to potable water due to human contamination. River Kuywa water is currently experiencing contamination due to human activities. Its water is widely used for domestic, agricultural, industrial and recreational purposes. This study aimed at characterizing bacteria and fungi in river Kuywa water. Water samples were randomly collected from four sites of the river: site A (Matisi), site B (Ngwelo), site C (Nzoia water pump) and site D (Chalicha), during the dry season (January-March 2018) and wet season (April-July 2018) and were transported to Maseno University Microbiology and plant pathology laboratory for analysis. The characterization and identification of bacteria and fungi were carried out using standard microbiological techniques. Nine bacterial genera and three fungi were identified from Kuywa river water. Clostridium spp., Staphylococcus spp., Enterobacter spp., Streptococcus spp., E. coli, Klebsiella spp., Shigella spp., Proteus spp. and Salmonella spp. Fungi were Fusarium oxysporum, Aspergillus flavus complex and Penicillium species. Wet season recorded highest bacterial and fungal counts (6.61-7.66 and 3.83-6.75cfu/ml) respectively. The results indicated that the river Kuywa water is polluted and therefore unsafe for human consumption before treatment. It is therefore recommended that the communities to ensure that they boil water especially for drinking.
Kinetic studies on malachite green dye adsorption from aqueous solutions by A...Open Access Research Paper
Water polluted by dyestuffs compounds is a global threat to health and the environment; accordingly, we prepared a green novel sorbent chemical and Physical system from an algae, chitosan and chitosan nanoparticle and impregnated with algae with chitosan nanocomposite for the sorption of Malachite green dye from water. The algae with chitosan nanocomposite by a simple method and used as a recyclable and effective adsorbent for the removal of malachite green dye from aqueous solutions. Algae, chitosan, chitosan nanoparticle and algae with chitosan nanocomposite were characterized using different physicochemical methods. The functional groups and chemical compounds found in algae, chitosan, chitosan algae, chitosan nanoparticle, and chitosan nanoparticle with algae were identified using FTIR, SEM, and TGADTA/DTG techniques. The optimal adsorption conditions, different dosages, pH and Temperature the amount of algae with chitosan nanocomposite were determined. At optimized conditions and the batch equilibrium studies more than 99% of the dye was removed. The adsorption process data matched well kinetics showed that the reaction order for dye varied with pseudo-first order and pseudo-second order. Furthermore, the maximum adsorption capacity of the algae with chitosan nanocomposite toward malachite green dye reached as high as 15.5mg/g, respectively. Finally, multiple times reusing of algae with chitosan nanocomposite and removing dye from a real wastewater has made it a promising and attractive option for further practical applications.
ENVIRONMENT~ Renewable Energy Sources and their future prospects.tiwarimanvi3129
This presentation is for us to know that how our Environment need Attention for protection of our natural resources which are depleted day by day that's why we need to take time and shift our attention to renewable energy sources instead of non-renewable sources which are better and Eco-friendly for our environment. these renewable energy sources are so helpful for our planet and for every living organism which depends on environment.
Presented by The Global Peatlands Assessment: Mapping, Policy, and Action at GLF Peatlands 2024 - The Global Peatlands Assessment: Mapping, Policy, and Action
Evolving Lifecycles with High Resolution Site Characterization (HRSC) and 3-D...Joshua Orris
The incorporation of a 3DCSM and completion of HRSC provided a tool for enhanced, data-driven, decisions to support a change in remediation closure strategies. Currently, an approved pilot study has been obtained to shut-down the remediation systems (ISCO, P&T) and conduct a hydraulic study under non-pumping conditions. A separate micro-biological bench scale treatability study was competed that yielded positive results for an emerging innovative technology. As a result, a field pilot study has commenced with results expected in nine-twelve months. With the results of the hydraulic study, field pilot studies and an updated risk assessment leading site monitoring optimization cost lifecycle savings upwards of $15MM towards an alternatively evolved best available technology remediation closure strategy.
A better understanding of the OECD Test Guidelines Programme and the validation principles in action
1. INTRODUCTION TO THE OECD
TEST GUIDELINES PROGRAMME
Anne Gourmelon
Principal Administrator
OECD Test Guidelines Programme
Environmental, Health and Safety Division
2. OECD Mutual Acceptance of Data system
Test Guidelines Good Laboratory Practice
Mutual
Acceptance of
Data
OECD members and MAD adhering countries
OECD Council Decision
1981
“Tested once, accepted everywhere”
5 sections
190 Guidelines
OECD is a consensus-
based organisation
3. • Working Party of the National Coordinators of the Test
Guidelines Programme (WNT)
– One or more National Coordinator(s) for each member and
MAD adhering country and the European Commission,
nominated by the HoD in the parent Chemicals and
Biotechnology Committee (CBC)
https://www.oecd.org/chemicalsafety/testing/national-coordinators-test-
guidelines-programme.htm
– Business and Industry Advisory Committee (BIAC), own
coordinator
– Non-governmental organisations
• International Council on Animal Protection in OECD
Programmes ICAPO, own coordinator
• European Environmental Bureau (EEB), own coordinator
– Secretariat team (8 staff members, 4 of which full time)
A Working Party to oversee the TG Programme
4. • One annual meeting, usually in April in Paris:
– Approval of Test Guidelines and related documents
– Decisions on new projects proposed by member
countries
– Review of on-going projects on the TGP work plan
– Discussion on programme-related issues
Meetings of the WNT
With regular participation of countries with
observer status:
- People’s Republic of China
- Russian Federation
5. • Advisory Group on Endocrine
Disrupters Testing and
Assessment (EDTA AG)
– EDTA-related methods, approaches,
strategies for both HH and ENV
• Advisory Group on Molecular
Screening and Toxicogenomics
(EAGMST)
– AOP Development Programme
– Omics (reporting formats,…)
Advisory Groups affiliated to the
TG Programme
Reporting
directly to
the WNT
Parent bodies:
WNT and Working
Party on Hazard
Assessment
(WPHA)
6. • Projects are led by member countries
– One or more members can lead a project
– Input/contribution on a voluntary basis
– Projects based on a regulatory need
– Template (SPSF) for project proposals to document:
• Rationale for the proposal, intended product/deliverable
• Regulatory need
• Resources involved, timelines, need for an Expert Group
• Animal welfare considerations
• Intellectual property rights in methods proposed
• Cycle: mid-November proposals are submitted
Projects on the TGP work plan
7. • What is the regulatory need?
• Is the output for one or more countries?
• Is the proposed TG broadly applicable?
(or just for a class of chemicals/a chemical sector)?
• Is the proposed method intended to replace an existing TG?
• What is the validation status of the proposed method?
• What is the action plan and timelines?
• Need for an Expert Group? Meeting needs?
• Are there protected elements? If yes:
– What are they? What type of protection?
– What are the means to ensure broad availability across
countries? FRAND declaration.
• Is the proposed method similar (me-too) to an existing TG?
Information to provide in SPSF
8. • Project proposals (SPSF)
Review of draft documents - Timelines
15 Nov ---- review/comments 15 Jan---responses and proposals revision 28 Feb WNT April meeting
SPSF
submission
Compilation
of comments
Responses
and revised
proposals by
proposing
countries
Decision by member countries
to include/not the project on
the TGP work plan
Loading of documents on
the WNT community site
(not public) TGP work plan approved and
declassified by the CBC
Published on annual basis
https://www.oecd.org/env/ehs/testing/work-plan-test-guidelines-programme-july-2021.pdf
9. Test Guidelines Programme - workplan
9 projects: mainly on physical-chemical
properties of nanomaterials
12 projects: mainly on aquatic toxicity testing
(fish, invertebrates, plants) and for ED testing
7 projects: half are for nanomaterials testing
30 projects: mostly on non-animal methods
for skin and eye irritation, skin sensitisation,
genotoxicity, developmental neurotoxicity,
immunotoxicity, ED testing
3 projects on biocide efficacy
10. • WNT nominates experts to participate in expert
groups to develop documents
– Includes academic researchers, regulatory scientists,
experts nominated by industry (BIAC), experts nominated
by non-governmental organisations (ICAPO, EEB)
– Expert Groups are active as long as there is a project
relevant to their area on the TGP work plan
Expertise to support the TG Programme
Genotoxicity testing
Skin/eye irritation/phototoxicity
Skin sensitisation
Non-genotoxic carcinogenicity
Developmental neurotoxicity
Immunotoxicity
Physical-chemical properties of nanomaterials
Environmental fate of nanomaterials
Ecotoxicity testing in aquatic/sediment environment
Main active Expert Groups
on multiple/large projects
11. Nature of tools developed in the TG
Programme
Covered my MAD
• Test Guidelines
• Guideline on Defined Approaches
• Combinations of information sources have been individually
evaluated
Other important documents
• Guidance Documents in support of testing and assessment
• Detailed Review Papers in new areas of chemical toxicity testing
• Validation reports
• Peer review reports
Other tools (courtesy of the test developers)
• Excel spreadsheets for raw data collection and calculation sheets
• COTS software
12. Methods described in Test Guidelines typically result from an evaluation of
their relevance and reliability/robustness, using a representative set of
chemicals for which they are intended to be applied
• Any limitations identified are described in the Test Guideline
• Any data transformation (statistical)/interpretation procedure (prediction
model) used in the development of the method and evaluated/accepted by
the WNT, is described in the Test Guideline
• A validation report/supporting document is published showing how the
method performs
– Guidance Document No 34: provide a modular approach to validation of methods
for hazard assessment of chemicals
– Good In Vitro Method Practice No 286: provides instructions on best practice for
any aspects of in vitro methods (development and implementation)
When a method is approved as a (Test) Guideline, regulators are confident in
its relevance and reliability
• These aspects need not be demonstrated each time the method is
subsequently used.
Development of Test Guidelines
13. Process, workflow and timelines for TG-
related project development
SPSF submitted by
lead country(ies)
- 15 November
Expert Group work
on technical aspects
of the Test Guideline
and consensus
building
Meetings/TCs
WNT reviews and
finally approves final
draft document
Committee
(CBC) endorses
TG/GL
If approved,
project starts
14. Test Guidelines team
Anne Gourmelon
Principal Administrator
Nathalie DELRUE, Administrator
Areas covered: genotoxicity,
carcinogenicity, skin sensitization, AOP
Programme
Mar GONZALEZ, Administrator
Areas covered: nanomaterials safety
testing
Leon VAN DER WAL, Administrator
Areas covered: aquatic toxicity,
environmental fate and behaviour
Magdalini SACHANA, Administrator
Areas covered: Developmental
neurotoxicity, AOP Programme
Eugene CHOI, Administrator
Areas covered: skin and eye irritation,
phototoxicity
Yusuke OKU, Administrator
Areas covered: genotoxicity,
carcinogenicity
Carole Guerrier, Programme Assistant
16. • What is the regulatory need?
• Is the output for one or more countries?
• Is the proposed TG broadly applicable?
(or just for a class of chemicals/a chemical sector)?
• Is the proposed method intended to replace an existing TG?
• What is the validation status of the proposed method?
• What is the action plan and timelines?
• Need for an Expert Group? Meeting needs?
• Are there protected elements? If yes:
– What are they? What type of protection?
– What are the means to ensure broad availability across
countries? Elaborate.
• Is the proposed method similar (me-too) to an existing TG?
Information to provide in SPSF
Rationale to provide for me-too methods
(one or more item should match the proposal):
• No intellectual property restriction/freely available
• Broader geographical availability
• Broader/complementary domain of applicability
• Reduced cost or analysis time
• Reduction in animal/animal product use (e.g. serum)
• Inclusion of inherent metabolic capacity or proven
possibility of combination with metabolising system
• Improved mechanistic insight
• Additional toxicity endpoints (to those covered in the
TG)
• Reduction in hazardous reagents
• Improved predictivity.
17. Reflections on the Test Guidelines
Programme
Tim Singer
Chair, Working Party of the National Coordinators of the Test Guidelines
Programme
18. Working Party of the National Coordinators of the Test Guidelines Programme
2
• The governance body for the Test Guidelines Programme.
• As an entity within the OECD framework, operates on a
consensus basis.
• All decisions are made following extensive consultation.
• National Coordinators (NCs) are the focal point for TGP
activities in their countries and represent their countries at the WNT.
• Small turnover of NCs from year to year, but a core group remains
constant – significant corporate memory within the body and a
high degree of consistency of approach.
19. Key Trends and Observations Regarding the Test Guidelines Programme
• There is a significant user base and now nearly 40 years of experience
with the Test Guidelines as tools supporting sound regulation of chemicals.
• Mutual Acceptance of Data has become indispensable in avoiding
duplication and in establishing scientifically sound methods to
support protection of human health and the environment.
• Animal welfare considerations have grown in importance over the past
10+ years – emergence and acceleration of alternative methods.
• Test Guidelines have become more complex (and longer!) as efforts have
been made to provide more clarity and reduce ambiguity.
• Efforts to address intellectual property and avoid inadvertent monopolies
led to Performance Based Test Guidelines and an explosion of “me-too”
methods for some endpoints.
3
20. Future Opportunities and Challenges for the Programme
• Decisions around resource allocation may necessitate setting priorities – are there areas with
regulatory value that are not yet well covered by Test Guidelines?
• Delicate balance between maintaining transparency about methods used to support regulatory
decision-making and incentivizing innovation among test developers.
• Expansion of Defined Approach-based Test Guidelines to facilitate full replacement of animal
methods where warranted.
• Curation of the library of Test Guidelines – what to do with older and potentially obsolete
methods, or animal methods that may no longer be widely used? Work has started on
approaches here.
• Preserving Mutual Acceptance of Data in light of diverging requirements in certain countries or
regions.
4
21. Concluding Thoughts
• The Programme is well positioned to translate advances in science and method development
into guideline development in support of regulatory needs.
• There is an enormous community of experts that continues to support the Programme,
providing a solid scientific foundation for the future.
• As we continue to support and advance Mutual Acceptance of Data, continued collaboration
with the Working Party on GLP is essential and welcomed.
5
22. 1
Validation in a regulatory
context
Joint OECD WNT-GLP WP meeting
2 December 2021
Valérie Zuang
EU NC
23. 2
1. JRC/EURL ECVAM introduction
2. The definition and principles of validation
3. Novel concepts in the validation of alternative methods
4. Lessons learned (scientific and non-scientific issues)
Overview
24. 3
Science and knowledge service of the Commission
Support EU policies with independent evidence
~ 3000 staff
Almost 75% are scientists
Headquarters in Brussels
Research facilities in 5 EU Member States
The Joint Research
Centre (JRC)
25. 4 4
Directorate F
F.3.
Chemical Safety &
Alternative Methods
Ispra
F.4
Fraud
Detection &
Prevention
F.5
Food & Feed
Compliance
F.1
Health in
Society
F.2
Consumers
Products
Safety
F.6
Reference
Materials F.7. Knowledge
for Health &
Consumer
Safety
Joint Research Centre (JRC), Directorate F: Health, Consumers
and Reference Materials Geel (Belgium) & Ispra (Italy)
26. 5
o Guide research on alternative methods
o Coordinate validation within the EU
o Disseminate information on the 3Rs
o Promote stakeholder dialogue
o Promote international acceptance
Duties and tasks*
* Article 48 of the Directive, Annex VII
European Union Reference Laboratory
for Alternatives to Animal Testing
Established under the Directive 2010/63/EU on the
protection of animals used for scientific purposes
27. 6
EURL ECVAM Validation Process
Research &
Development
Validation
Independent
Peer Review
Implementation
PARERE/ESTAF
ESAC
EU NETVAL
ICATM
ICATM
EU, OECD, ISO,
ICH, VICH,
Pharmacopoeia
EURL ECVAM
Public
Test Submitter
International Recognition /
Regulatory Acceptance
PARERE/ESTAF
EURL ECVAM
Recommendation
28. 7
Overview
1. JRC/EURL ECVAM introduction
2. The definition and principles of validation
3. Novel concepts in the validation of alternative methods
4. Lessons learned (scientific and non-scientific issues)
29. 8
Validation
"The process by which the reliability and
relevance of a particular approach, method,
process or assessment is established for a
defined purpose"
31. 10
Purpose: applications in regulatory decision making
Mechanistic information Priority setting
Hazard identification Hazard characterisation
32. 11
• Increase confidence in a method by demonstrating its ability to provide
reproducible and relevant data
• Ensure sound science-based decisions are made to protect human
health and the environment
• Facilitate development of globally harmonized standard methods
Validation to build confidence and reach acceptance
− Not an impediment or a constraint
− Acceptance cannot be imposed
Why validation?
33. 12
The Modular Approach to validation
Relevance
Reliability
Reliability
Relevance
Independent
Peer
Review
Hartung et al. (2004).
ATLA 32, 467-472
"No sequential
assessment needed"
Validation
Management
Test definition
Within-lab reproducibility
Transferability
Between-lab reproducibility
Predictive capacity
Applicability domain
Performance standards
34. 13
Serious eye damage/eye irritation:
BCOP, ICE, HET-CAM; FL, CM
Genotoxicity:
Micronucleus assay
New
Test Method
Similar
Test Method
Modification of
validated /
approved /
established
Test Method
Established but
non-validated
Test Method
Prospective
Validation
Study
Performance
Standards-based
validation study
Retrospective
Validation
Study
Transfer
test to EURL-
ECVAM and
optimisation if
needed
Update based
on Performance
Standards
ECVAM Validation
Processes
Characteristics
Prospective multi-
laboratory ring trial
Validation in reference
to Performance Standards
Pre-defined Reference
Chemicals
Normally external studies
Evaluation based
on existing data
Typically no testing
Perhaps several SOPs,
PMs available
Skin corrosion:
EpiSkin™ SCT, TER
Skin irritation:
EpiSkin™ SIT, EpiDerm™ SIT
Serious eye damage/eye irritation :
EpiOcular™ EIT; STE
Skin sensitisation:
DPRA, h-CLAT, U-SENS;
KeratinoSens
Skin corrosion:
Epiderm™ SCT; epiCS®;
SkinEthic™ RHE SCT
Skin irritation
SkinEthic™ RHE SIT;
updated EpiDerm™ SIT
Skin sensitisation
LuSens
EXAMPLES
Test Method
Types
OECD TG 430
OECD TG 431
OECD TG 431
OECD TG 439
OECD TG 439
OECD TG 492 OECD TG 491
OECD TGs 437, 438, 460
OECD TG 442C, 442E
OECD TG 442D
OECD TG 487
35. 14
Overview
1. JRC/EURL ECVAM introduction
2. The definition and principles of validation
3. Novel concepts in the validation of alternative methods
4. Lessons learned (scientific and non-scientific issues)
36. 15
The modern safety assessment toolbox
DATA
INTEGRATION
PREDICT SAFETY
Exposure modelling
Cheminformatics &
QSAR modelling
Cell cultures
3D tissues
Organ-on-a-chip
High content
imaging
'OMICS
HTS
37. 16
The principles and process of validation
• PRINCIPLES are universal and valid
• PROCESS is adaptable depending on purpose (validation
towards universal acceptance vs. for specific use context)
• One size doesn’t fit all. Process needs to be fit for purpose!
38. 17
Overview
1. JRC/EURL ECVAM introduction
2. The definition and principles of validation
3. Novel concepts in the validation of alternative methods
4. Lessons learned (scientific and non-scientific issues)
39. 18
Workshops on validation
How to evolve
validation
practices?
How to develop
the concept of
standards?
JRC-Ispra, 23-24 October 2018
BfR-IRVM - Berlin, 2017, 2018
How to establish
relevance without
animal data?
How to evaluate
reliability without ring
trials?
40. 19
How to assess RELEVANCE of single methods
TIME and COST constraints
Poor/unknown quality of REFERENCE DATA
Too high focus on "GOLD STANDARD" and PREDICTIVE
CAPACITY
Poor CHEMICALS SELECTION introducing bias
Lab specific SOPs that hinder transferability
Lessons learned: scientific issues
41. 20
Restrained by REGULATORY REQUIREMENTS
ENGAGEMENT with stakeholders at every step
Tackling INTELLECTUAL PROPERTY (ensuring commercial
availability & avoiding abuse of monopolies)
Lack of TRANSPARENCY of protected elements
GLP IMPLEMENTATION of protected elements and
cloud-based computerised systems
Lessons learned: non-scientific issues
42. 21
Final thoughts
• Validation will remain one of the cornerstones of a successful toxicological
(r)evolution
• Validation needs to keep pace with rapid scientific progress, e.g. DAs,
computational models, Organ-on-Chip
• Important to maintaining scientific integrity, credibility and usefulness while
making process more efficient
• Frame validation as a process to characterise and reduce uncertainty rather than
a ring trial to demonstrate "toxicological equivalence"