There is no easy way or quick fix method to learn the OECD principles. You simply have to sit down, read the principles and ensure that you understand the material. You need to understand the purposes of the OECD principles. How is structured? And who the target audience is. In other words, who is it written for? Is it aimed at companies or directors? The answer is NEITHER. The OECD principles are actually directed towards government and legislatures who in turn write up the laws and regulations within specific jurisdictions. These principles are aimed at providing international best practices which will serve as a bench mark for individual legislatures to ensure that new requirements are aligned with these best practices. There are six core principles. These include: the basis for an effective corporate governance framework; the rights of shareholders and key ownership functions; the equitable treatment of shareholders; the role of stakeholders in corporate governance; disclosure and transparency; and the responsibilities of the board. For each principle, you need to understand the intention. In other words, what is the end goal and desired result? You also need to be familiar with the actual recommendations itself, in other words, how are the goals of each core principle going to be achieved? Let’s look at the core principle 2 as an example. The intention of this principle is to protect shareholder entitlements and also empower shareholders in relation to influencing corporate behaviour. So how does this principle achieve its intended purpose? From a high level overview of core principle 2, there are three important things. These include basic rights, The right to be informed and the right to participate and vote. Now we can expand on these by asking, so what are the basic rights. We are not referring here to freedom of speech, and other basic rights but rather to the basic rights related to their shareholding. To recap, the OECD principles comprises six core principles. You need to not only read them, but also be able to understand the intention behind each core principle and critically analyse how each principle is to be achieved.
Views: 19725 KnowledgEquity - Support for CPA
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Views: 13246 USDM Life Sciences
People are often confused by differences between Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. ... In addition, scientists and quality control/quality assurance personnel participating in GLP and GMP studies play different roles. Difference Between GMP and GLP. “GMP” is Good Manufacturing Practices, and “GLP” is Good Laboratory Practices. Both the GMP and the GLP are regulations that are governed by the Food and Drug Administration (FDA). These regulations are imposed for ensuring the safety and integrity of drugs.3) The OECD Principles of Good Laboratory Practice. 4) GLPs are not ... Function. GLP. GMP. GCP. Ownership. Facility. Management. Manufaturer. Sponsor.We often confused by the differences between Good Laboratory Practice (GLP) regulation and Good Manufacturing Practice (GMP) regulations ...GMP and GLP are regulations that have been imposed by FDA on health care product manufacturers. While GMP applies to goods that are ...Learn the basics of GCP, GLP, and GMP audits and key differences in what each audit is for and how they're conducted.Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). ... outlines the differences between GLP and GMP regulations that are significant to ...GMP and GLP are regulations that are governed by Food and Drug Administration (FDA) on Health Care product manufacturers. Differences between GMP and ...All You Never Wanted to Know About GLP and GMP. Research. By FDA standards . . . A VERY uncontrolled, undisciplined activity!!! Note: Innovation is the key.
Views: 1127 Health
Difference Between GMP and GLP. “GMP” is Good Manufacturing Practices, and “GLP” is Good Laboratory Practices. Both the GMP and the GLP are regulations that are governed by the Food and Drug Administration (FDA). ... When comparing the GLP and the GMP, the former one is considered to be less costly and less onerous.People are often confused by differences between Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. ... In addition, scientists and quality control/quality assurance personnel participating in GLP and GMP studies play different roles.Get a quick and simple breakdown of the differences between GMP and GLP in laboratory testing and validation.2) GLPs are regulations published in the Code of Federal. Regulations (21CFR part 58). 3) The OECD Principles of Good Laboratory Practice. 4) GLPs are not ...The quality of data or goods resulting from scientific research must be held to high standards. For this reason, the GLP regulations, GCP guidelines, and GMP guidelines must be followed. Good laboratory practice (GLP) regulates the processes and conditions under which clinical and non-clinical research is conducted.Could anyone please tell me what are the major differences between QA requirements in relation to laboratory analysis for GMP and GLP work.
Views: 56 Health Care
Difference Between GMP and GLP. “GMP” is Good Manufacturing Practices, and “GLP” is Good Laboratory Practices. Both the GMP and the GLP are regulations that are governed by the Food and Drug Administration (FDA). These regulations are imposed for ensuring the safety and integrity of drugs.People are often confused by differences between Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. ... In addition, scientists and quality control/quality assurance personnel participating in GLP and GMP studies play different roles.3) The OECD Principles of Good Laboratory Practice. 4) GLPs are not guidelines, ... 4 – EU Guidelines to GMP Medicinal products for human and veterinary use ...GMP and GLP are regulations that have been imposed by FDA on health care product manufacturers. While GMP applies to goods that are ...We often confused by the differences between Good Laboratory Practice (GLP) regulation and Good Manufacturing Practice (GMP) regulations ...GMP and GLP are regulations that are governed by Food and Drug Administration (FDA) on Health Care product manufacturers. Differences between GMP and ...Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). ... outlines the differences between GLP and GMP regulations that are significant to ... Learn the basics of GCP, GLP, and GMP audits and key differences in what each audit is for and how they're conducted.
Views: 330 HealthTips
Maria Dusinska @ Inge Nelissen
Views: 1417 TAUVOD
: จากการฝึกอบรมฯ EDUCATION COURSE FOR OECD GLP TRAINING : ขอขอบคุณ : - ผู้ช่วยศาสตราจารย์ ดร.พรนรินทร์ เทพาวราพฤกษ์ ผู้อำนวยการสถานสัตว์ทดลองฯ - นายอมร ประดับทอง ผู้จัดการโครงการ ศูนย์ความเป็นเลิศด้านชีววิทยาศาสตร์ (องค์การมหาชน) /TCELS - Dr.Boo Hyon Kang, DVM, PhD, FIATP หน่วยงาน Chemon Inc.
Views: 88 Naresuan University
Conducting Responsible International Business according to the OECD Guidelines with www.internationalguidelines.com
Views: 287 International Guidelines
The Organisation for Economic Co-operation and Development (OECD) (French: Organisation de coopération et de développement économiques, OCDE) is an international economic organisation of 34 countries founded in 1961 to stimulate economic progress and world trade. It is a forum of countries committed to democracy and the market economy, providing a platform to compare policy experiences, seek answers to common problems, identify good practices and coordinate domestic and international policies of its members. The OECD originated in 1948 as the Organisation for European Economic Co-operation (OEEC), led by Robert Marjolin of France, to help administer the Marshall Plan (which was rejected by the Soviet Union and its satellite states). This would be achieved by allocating American financial aid and implementing economic programs for the reconstruction of Europe after World War II, where similar efforts in the Economic Cooperation Act of 1948 of the United States of America, which stipulated the Marshall Plan that had also taken places elsewhere in the world to war-torn Republic of China and post-war Korea, but the American recovery program in Europe was the most successful one. This video is targeted to blind users. Attribution: Article text available under CC-BY-SA Creative Commons image source in video
Views: 346 Audiopedia
ทีเซลล์ร่วมยกระดับมาตรฐานความปลอดภัยผลิตภัณฑ์ “OECD GLP Implementation for Test Facility” ออกอากาศรายการ "ข่าววันใหม่" ทางช่อง 3 HD (กดหมายเลข 33) วันอังคารที่ 16 มกราคม 2561
Views: 20 TCELS Thailand
Creative Bioarray uses the state-of-the-art automated QPatch-HT system to provide a higher-throughput hERG safety assay with better consistency at a lower cost. For small number of compounds or compounds identified with QPatch, we can also perform conventional whole cell patch clamp assay to get detailed mechanistic information. Our GLP level hERG safety assay can provide high quality data for registration purposes. Email: [email protected]
Views: 427 Creative Bioarray
Subject:Biotechnology Paper: Environmental Biotechnology
Views: 198 Vidya-mitra
Good Laboratory Practices (GLP) for animal facilities is intended to assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.The goal of these Guidelines is to promote the humane care of animals used in biomedical and behavioural research and testing with the basic objective of providing specifications that will enhance animal well-being, quality in the pursuit of the advancement of the biological knowledge that is relevant to humans and animals.All animals must be acquired lawfully as per the CPCSEA guidelines. A health surveillance program for screening incoming animals should be carried out to assess animal quality. Methods of transportation should also be taken into account. pushpendra patel solution pharmacy Get in touch with solution by just clicking following links- Facebook page- https://www.facebook.com/pharmavideo/ Facebook Group- https://www.facebook.com/groups/solutionpharamcy Instagram- https://www.instagram.com/solutionpharmacy/ Mail Us for Free Pharmacology Materials- [email protected] LinkedIn- http://linkedin.com/in/pushpendrakpatel Review and rating - https://www.facebook.com/pg/pharmavideo/reviews/?ref=page_internal
Views: 2260 Solution- Pharmacy
Pharmacelsus GmbH is a GLP-certified preclinical CRO in Saarbrücken (Germany) and provides the pharmaceutical industry with a range of high quality drug discovery and development solutions. Information on the Pharmacelsus service portfolio can be found at: http://www.pharmacelsus.de Individual & personal, reliable and dedicated - this is Pharmacelsus!
Views: 1057 Pharmacelsus
A complete description of Chromosomal Aberration Assay including Introduction, Chromosome Morphology, Types of Chromosomal aberrations, Method, Requirements, Data and reporting, Evaluation and interpretation of results CA characteristics, Advantages/Disadvantages. Find me: 👍 Facebook: https://www.facebook.com/Centreoflearning1/ 📷 Instagram: https://www.instagram.com/centre_of_learning/ 🐥 Twitter: https://twitter.com/Free_Pptx 🌹 https://www.youtube.com/channel/UCcnCVaeAefh8SZ1ZDa2q9Tw?sub_confirmation=1 Please like and subscribe and keep in touch for every new presentation. Thanks for the support
Views: 2129 Centre of Learning
Einführung http://glp2.colayer.com: Webseite der Arbeitsgruppe Social Media der glp Zürich.
Views: 130 Markus Hegi - Nagavkar
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don’t know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.
Views: 757 Compliance Trainings
Session 1: Addressing non-clinical requirements during the medicinal product development Milton Bonelli, Clinical Pharmacology & Non-Clinical Support, EMA
Views: 502 emainfo
This is a Special Video Series [in #English] describing principles of operation of the Russian Market of Human Medicinal Products. We did it to highlight what is happening in this area for foreign companies and other interested parties for whom Russian is not the mother tongue. This video describes general regulatory framework and main pre-authorization issues, including GMP certification, non-clinical, and clinical testing. We hope that the provided information will help you to understand the basics of placing medicinal products for human use on Russian pharmaceutical market. The rules are not that stringent but rather protective. At the same time, great efforts are being made to develop a robust rules and procedures in the EAEU legal framework.
Views: 360 PhED
The development of a novel drug is an expensive and time consuming endeavor. While the discovery of hits from a high throughput screening (HTS) campaign is relatively successful, later compound development stages have a much higher attrition rate. In this context, toxicity evaluation is one of the most important aspects of drug development. In this symposium, we hope to give an overview of the basic aspects of in vitro toxicity testing. We will focus on oxidative stress and small molecule-induced liver injury, one of the main reasons for withdrawal of drugs from the market. This symposium aims at investigators who have no prior background in drug development and is intended to provide a forum where they can learn about early toxicity evaluation of small molecules from experts. We also hope that this symposium will start the discussion towards the development of a more standardized approach to in vitro toxicity testing. Presented by UC Center for Accelerated Innovation. For more information, visit: https://uccai.ctsi.ucla.edu/pages/drug_design
Views: 369 UCLA CTSI
Altogen Labs http://altogenlabs.com provides in vivo toxicology and pharmacology services http://altogenlabs.com/biology-laboratory-cro-services/in-vivo-toxicology-service/. Toxicology studies can be focused on the acute toxicological effects after a single large dose of a substance as well as long-term studies focused on researching subchronic and chronic effects. A subchronic toxicology study can include repeatedly administering small doses of the substance in question over a period of up to 90 days. Chronic studies, on the other hand, can study the toxic effects of the experimental substance for months to years. -Purpose of Toxicology Testing Preclinical toxicology studies are required to establish the toxicological profiles of new drug candidates prior to administration to humans, and to extend the known profiles of existing drugs (e.g., new indications, new formulations, new routes of administration, etc.). Preclinical studies used for direct extrapolation to human safety should be conducted according to GLP. The studies vary in length (e.g., acute, sub-chronic, chronic) depending on the length of dosing in the clinical trial they are supporting and the stage of development of the test article (IND, NDA, BLA, etc.). Acute toxicology studies focus on the toxicological effects following a single large dose of the substance of interest. Sub-chronic toxicology studies include repeated small dosages of the test substance over a period of time up to 90 days. Chronic toxicology studies focus on the long-term effects of the test substance over periods of months to years. -In Vivo Toxicology Service (Mouse, Rat) Preclinical in vivo toxicology is the study of toxic effects of chemical substances based on statistical and quantitative analysis. They assess the onset, severity, and duration of toxic effects, their dose dependency and degree of reversibility or irreversibility). At Altogen Labs, toxicology studies can include acute, sub-chronic and chronic toxicity tests via several routes of exposure (e.g., oral, intravenous, intramuscular, topical, etc.). The Study designs are flexible and can be customized to the client-specific projects. All testing complies with applicable Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations as needed. -The variation in time and amount of test substance in taken by the subject helps create dose response curves to determine thresholds of biological activity associated with the test substance as well as levels of toxicity. Identification of potential toxicological side effects is very important to the advance of INDs to phase 1 clinical trial. Such side effects can have an impact on the future health of the subject, its progeny, and overall survival rate. Potential side effects can be detrimental to the immune system, the integrity of the DNA and the functionality of vital organs. Hence additional tests can be run to study sensitivity, irritation, mutagenic and/or carcinogenic properties, reproductive toxicity and immuno-toxicity. -Another focal point is the route of administration of INDs. The ability of a drug to reach its target in a living system can unintentionally be deterred by immune system mechanisms, metabolic processes, and similarly natural mechanisms. Then the INDs are no longer directly targeting the desired cells but are faced with a living biological system in which their target is one of many. As a result, various drug administration routes are explored to determine toxicity and benefits. Evaluation of drug administration routes should anticipate clinical results and optimize beneficial efficacy. Thus the study should determine a safe and effective procedure for administration, as well as dosage for the drug to prevent any adverse effects. -In vivo toxicology studies are also required to establish the toxicological profiles of materials that may pose a significant human health risk via environmental exposure Implications of the above these studies can lead to phase 1 clinical trial INDs if they show promising results and minimal toxicological, carcinogenic and mutagenic effects. Studies focusing on pharmacodynamics, pharmacokinetics and ADME processes also contribute greatly to the INDs application. Refer the link for more details on FDA application for INDs: http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm -Our Services Acute toxicity Sub chronic toxicity Chronic toxicity Pharmacokinetics In vitro permeation studies In vivo absorption studies Irritation and sensitization Immunotoxicity Reproductive toxicity Pharmacology Connect to Altogen Labs: LinkedIn - https://www.linkedin.com/company/altogen-labs/ Twitter - https://twitter.com/altogen?lang=en Facebook - https://www.facebook.com/Altogen.CRO/
Views: 342 Altogen Labs
Watch on LabRoots at: http://labroots.com/user/webinars/details/id/165 This presentation mainly includes 4 sections, the first one: introduction for CFDA/FDA GLP Regulation and analysis the difference. The second one: introduction of the most important responsibility of veterinarian, for example: to supply support to scientist, to supply veterinary care promptly, to ensure the animal welfare and enrichment. The third one: The procedure for observation of abnormal animal. The fourth one: case for case, for example, alopecia, dehydration, decrease the consumption of food, not drink water, decrease the activity, diarrhea, mass or tumor. Outline - Requirements for animal welfare and veterinary care in related regulations of toxicology study - Requirement for laboratory animals in CFDA GLP regulations - Requirement for laboratory animals in FDA GLP regulations - Requirement for laboratory animals in OECD GLP regulations - Responsibility of veterinarian in the toxicology study - To supply support to scientist - To supply veterinary care promptly - To ensure the animal welfare and enrichment - The procedure for observation of abnormal animal - Case - Alopecia - Dehydration - Decrease the consumption of food, not drink water - Decrease the activity - Diarrhea - Mass or tumor
Views: 112 LabRoots
This is a Special Video Series [in #English] describing principles of operation of the Single Market of Human Medicinal Products in the EAEU. We did it to highlight what is happening in this area for foreign companies and other interested parties for whom Russian is not the mother tongue. We hope that the provided information will help you to understand the basics of the EAEU Single Market rules better. The rules are quite robust but need further development to achieve a level equivalent to that effective in developed countries. Currently, great efforts are being made to complement the rules with other documents and procedures. This video deals with main documents creating a legal and operational framework for the functioning of the Single Market.
Views: 376 PhED
Addressing repeated-dose systemic toxicity with non-animal methods is a substantial research challenge: a state of the art review published in 2011 by Adler et al., concluded that a full replacement of the animal tests used for repeated dose/reproductive and developmental toxicity testing was not available and the timeframe for a full replacement could not be clearly estimated. Since then, several research initiatives have made progress in Europe and overseas in developing different approaches covering bioactivity with in vitro and in silico methods, adverse outcome pathways and exposure. To assess this endpoint, a point of departure is needed in lieu of the historical data derived from the animal studies. Gladys Ouedraogo, Pharm.D, Ph.D Please find out more here: http://www.opentox.net/events/opentox-euro-2015/session7/evaluating-systemic-toxicity
Views: 109 Edelweiss Connect, Switzerland
PREVIEW: ACRP's on-demand eLearning Course provides formal introductory training, or a refresher, on the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP), the globally recognized standard for the conduct of clinical trials. For more information about this clinical research training course, please visit http://www.acrpnet.org/goodclinicalpractice.
Views: 11337 Assocation of Clinical Research Professionals
Recorded April 14, 2016
Views: 2038 CCTS
Views: 8 Allison Maule