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Qualified Person (European Union)
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 Supranational union, supranational Law, laws operating within the 27 member states of the European Union (EU). It has grown over time since the 1952 founding of the European Coal and Steel Community, to promote peace, social justice, a social market economy with full employment, and environmental protection. The Treaties of the European Union agreed to by member states form its constitutional structure. EU law is interpreted by, and EU case law is created by, the judicial branch, known collectively as the Court of Justice of the European Union. Legal Act of the European Union, Legal Acts of the EU are created by a variety of European Union legislative procedure, EU legislative procedures involving the popularly elected European Parliament, the Council of the European Union (which represents member governments), the European Commission (a cabinet which is elected jointly by the Council and Parliament) and sometimes the European Council (composed o ... [...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 in English in the Commonwealth of Nations, Commonwealth English, is a healthcare professional who is knowledgeable about preparation, mechanism of action, clinical usage and legislation of medications in order to dispense them safely to the public and to provide consultancy services. A pharmacist also often serves as a primary care provider in the community and offers services, such as health screenings and immunizations. 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. In developing countries, a diploma course from approved colleges qualifies one for pharmacist role. 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 ... [...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 (biology), cell, a multicellular organism, or a Community (ecology), community of Biological interaction, interacting populations. They usually specialize in a particular Outline of biology#Subdisciplines, 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 hypothesis, hypotheses. Their discoveries may have Applied science#Applied research, 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 degre ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Chemist
A chemist (from Greek ''chēm(ía)'' alchemy; replacing ''chymist'' from Medieval Latin ''alchemist'') is a graduated scientist trained in the study of chemistry, or an officially enrolled student in the field. 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 Chemistry#Subdisciplines, subdisciplines of chemistry. Materials science, Materials scientists and metallurgists sha ... [...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 pharmaceutical 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 ... [...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 * Eud ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
