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Qualified Person
Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU. Such provisions include that the batch was manufactured under appropriate standards, and that it passed all required testing. The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements.(EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union Law
European Union law is a system of rules operating within the member states of the European Union (EU). Since the founding of the European Coal and Steel Community following World War II, the EU has developed the aim to "promote peace, its values and the well-being of its peoples". The EU has political institutions, social and economic policies, which transcend nation states for the purpose of cooperation and human development. According to its Court of Justice the EU represents "a new legal order of international law".''Van Gend en Loos v Nederlandse Administratie der Belastingen'' (1963Case 26/62/ref> The EU's legal foundations are the Treaty on European Union and the Treaty on the Functioning of the European Union, currently unanimously agreed on by the governments of 27 member states. New members may join if they agree to follow the rules of the union, and existing states may leave according to their "own constitutional requirements".TEart 50 On the most sophisticated discu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes EudraLex consists of 10 volumes: *Concerning Medicinal Products for Human use: **Volume 1 - Pharmaceutical Legislation. **Volume 2 - Notice to Applicants. ***Volume 2A deals with procedures for marketing authorisation. ***Volume 2B deals with the presentation and content of the application dossier. ***Volume 2C deals with Guidelines. **Volume 3 - Guidelines. *Concerning Medicinal Products for human use in clinical trials (investigational medicinal products). **Volume 10 - Clinical trials. *Concerning Veterinary Medicinal Products: **Volume 5 - Pharmaceutical Legislation. **Volume 6 - Notice to Applicants. **Volume 7 - Guidelines. **Volume 8 - Maximum residue limits. *Concerning Medicinal Products for Human and Veterinary use: **Volume 4 - Good Manufacturing Practices. **Volume 9 - Pharmacovigilance. *Miscellaneous: **Guidelines on Good Distribution Practice of Medicinal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacist
A pharmacist, also known as a chemist (Commonwealth English) or a druggist (North American and, archaically, Commonwealth English), is a healthcare professional who prepares, controls and distributes medicines and provides advice and instructions on the correct and safe use of medicines to achieve maximum benefit, minimal side effects and to avoid drug interactions. They also serve as primary care providers in the community. Pharmacists undergo university or graduate-level education to understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. This is mated to anatomy, physiology, and pathophysiology. Pharmacists interpret and communicate this specialized knowledge to patients, physicians, and other health care providers. Among other licensing requirements, different countries require pharmacists to hold either a Bachelor of Pharmacy, Master of Pharmacy, or Doctor of Pharmacy d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biologist
A biologist is a scientist who conducts research in biology. Biologists are interested in studying life on Earth, whether it is an individual cell, a multicellular organism, or a community of interacting populations. They usually specialize in a particular branch (e.g., molecular biology, zoology, and evolutionary biology) of biology and have a specific research focus (e.g., studying malaria or cancer). Biologists who are involved in basic research have the aim of advancing knowledge about the natural world. They conduct their research using the scientific method, which is an empirical method for testing hypotheses. Their discoveries may have applications for some specific purpose such as in biotechnology, which has the goal of developing medically useful products for humans. In modern times, most biologists have one or more academic degrees such as a bachelor's degree plus an advanced degree like a master's degree or a doctorate. Like other scientists, biologists can be fou ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Chemist
A chemist (from Greek ''chēm(ía)'' alchemy; replacing ''chymist'' from Medieval Latin ''alchemist'') is a scientist trained in the study of chemistry. Chemists study the composition of matter and its properties. Chemists carefully describe the properties they study in terms of quantities, with detail on the level of molecules and their component atoms. Chemists carefully measure substance proportions, chemical reaction rates, and other chemical properties. In Commonwealth English, pharmacists are often called chemists. Chemists use their knowledge to learn the composition and properties of unfamiliar substances, as well as to reproduce and synthesize large quantities of useful naturally occurring substances and create new artificial substances and useful processes. Chemists may specialize in any number of subdisciplines of chemistry. Materials scientists and metallurgists share much of the same education and skills with chemists. The work of chemists is often related to the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Inspection Convention And Pharmaceutical Inspection Co-operation Scheme
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. History The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the ''Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products''. The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with othe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not onl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EUDRANET
EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications. The aim of EUDRANET is to provide appropriate secure services for inter-Administration data interchange and for exchanges between Administrations and industry. EUDRANET is based on the TESTA backbone infrastructure provided by the IDA Programme. The processes which EUDRANET supports include: * The submission and evaluation of marketing authorisation applications by pharmaceutical companies; * The pharmacovigilance of products on the market to ensure the maintenance of high standards of quality as well as adhering to European national and regional regulations; * The dissemination of relevant information to industry, scientific experts and regulators. See also * eHealth * EudraCT * EudraGMP * EudraPharm * EudraVi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
