Pharmacovigilance: The detection of long and short term side effects of conventional and traditional medicines through research, data mining, monitoring, and evaluation of healthcare information obtained from healthcare providers and patients.Adverse Drug Reaction Reporting Systems: Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions.Product Surveillance, Postmarketing: Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.Drug-Related Side Effects and Adverse Reactions: Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.Pharmacoepidemiology: The science concerned with the benefit and risk of drugs used in populations and the analysis of the outcomes of drug therapies. Pharmacoepidemiologic data come from both clinical trials and epidemiological studies with emphasis on methods for the detection and evaluation of drug-related adverse effects, assessment of risk vs benefit ratios in drug therapy, patterns of drug utilization, the cost-effectiveness of specific drugs, methodology of postmarketing surveillance, and the relation between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines. (Pharmacoepidemiol Drug Saf 1992;1(1); J Pharmacoepidemiol 1990;1(1))Plants, Medicinal: Plants whose roots, leaves, seeds, bark, or other constituent parts possess therapeutic, tonic, purgative, curative or other pharmacologic attributes, when administered to man or animals.Sex Reassignment Procedures: Clinical treatments used to change the physiological sexual characteristics of an individual.Drug Monitoring: The process of observing, recording, or detecting the effects of a chemical substance administered to an individual therapeutically or diagnostically.Data Mining: Use of sophisticated analysis tools to sort through, organize, examine, and combine large sets of information.Poison Control Centers: Facilities which provide information concerning poisons and treatment of poisoning in emergencies.United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Artemisinins: A group of SESQUITERPENES and their analogs that contain a peroxide group (PEROXIDES) within an oxepin ring (OXEPINS).Databases, Factual: Extensive collections, reputedly complete, of facts and data garnered from material of a specialized subject area and made available for analysis and application. The collection can be automated by various contemporary methods for retrieval. The concept should be differentiated from DATABASES, BIBLIOGRAPHIC which is restricted to collections of bibliographic references.Nurse Midwives: Professional nurses who have received postgraduate training in midwifery.Risk Management: The process of minimizing risk to an organization by developing systems to identify and analyze potential hazards to prevent accidents, injuries, and other adverse occurrences, and by attempting to handle events and incidents which do occur in such a manner that their effect and cost are minimized. Effective risk management has its greatest benefits in application to insurance in order to avert or minimize financial liability. (From Slee & Slee: Health care terms, 2d ed)Antimalarials: Agents used in the treatment of malaria. They are usually classified on the basis of their action against plasmodia at different stages in their life cycle in the human. (From AMA, Drug Evaluations Annual, 1992, p1585)France: A country in western Europe bordered by the Atlantic Ocean, the English Channel, the Mediterranean Sea, and the countries of Belgium, Germany, Italy, Spain, Switzerland, the principalities of Andorra and Monaco, and by the duchy of Luxembourg. Its capital is Paris.Tertiary Care Centers: A medical facility which provides a high degree of subspecialty expertise for patients from centers where they received SECONDARY CARE.Financing, Organized: All organized methods of funding.Ethnobotany: The study of plant lore and agricultural customs of a people. In the fields of ETHNOMEDICINE and ETHNOPHARMACOLOGY, the emphasis is on traditional medicine and the existence and medicinal uses of PLANTS and PLANT EXTRACTS and their constituents, both historically and in modern times.Malaria: A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.Medicine, Traditional: Systems of medicine based on cultural beliefs and practices handed down from generation to generation. The concept includes mystical and magical rituals (SPIRITUAL THERAPIES); PHYTOTHERAPY; and other treatments which may not be explained by modern medicine.Plasmodium: A genus of protozoa that comprise the malaria parasites of mammals. Four species infect humans (although occasional infections with primate malarias may occur). These are PLASMODIUM FALCIPARUM; PLASMODIUM MALARIAE; PLASMODIUM OVALE, and PLASMODIUM VIVAX. Species causing infection in vertebrates other than man include: PLASMODIUM BERGHEI; PLASMODIUM CHABAUDI; P. vinckei, and PLASMODIUM YOELII in rodents; P. brasilianum, PLASMODIUM CYNOMOLGI; and PLASMODIUM KNOWLESI in monkeys; and PLASMODIUM GALLINACEUM in chickens.Pharmaceutical Preparations: Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.Phytotherapy: Use of plants or herbs to treat diseases or to alleviate pain.Carum: A plant genus of the family Apiaceae. The seeds are used as flavoring.Herbal Medicine: The study of medicines derived from botanical sources.Mentha piperita: A plant genus of the family LAMIACEAE that is the source of peppermint oil.Pharmacy Administration: The business and managerial aspects of pharmacy in its broadest sense.Plant Preparations: Material prepared from plants.Biosimilar Pharmaceuticals: BIOLOGIC PRODUCTS that are imitations but not exact replicas of innovator products.Biopharmaceutics: The study of the physical and chemical properties of a drug and its dosage form as related to the onset, duration, and intensity of its action.Biological Products: Complex pharmaceutical substances, preparations, or matter derived from organisms usually obtained by biological methods or assay.Biotechnology: Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., GENETIC ENGINEERING) is a central focus; laboratory methods used include TRANSFECTION and CLONING technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction.Medicine, Kampo: System of herbal medicine practiced in Japan by both herbalists and practitioners of modern medicine. Kampo originated in China and is based on Chinese herbal medicine (MEDICINE, CHINESE TRADITIONAL).Drugs, Chinese Herbal: Chinese herbal or plant extracts which are used as drugs to treat diseases or promote general well-being. The concept does not include synthesized compounds manufactured in China.BooksTextbooks as Topic: Books used in the study of a subject that contain a systematic presentation of the principles and vocabulary of a subject.Glycyrrhiza: A genus of leguminous herbs or shrubs whose roots yield GLYCYRRHETINIC ACID and its derivative, CARBENOXOLONE.Senna Extract: Preparations of Cassia senna and C. angustifolia (see SENNA PLANT). They contain sennosides, which are anthraquinone type CATHARTICS and are used in many different preparations as laxatives.Poria: A genus of basiodiomycetous fungi in the family Coriolaceae. Members are known for infesting wood.Prevalence: The total number of cases of a given disease in a specified population at a designated time. It is differentiated from INCIDENCE, which refers to the number of new cases in the population at a given time.
  • As from 09.02.2019, for medicinal products subject to Directive 2011/62/EC in conjuction with Commission Delegated Regulation ( EU ) 2016/161 amending Directive 2001/83/EC, a unique identifier (UI) has to be included on the packaging as well as a device allowing verification of whether the packaging has been tampered with (anti-tempering device = ATD) . (bfarm.de)
  • As about 10,000 children were born with severe malformations, this thalidomide disaster prompted governments in several countries to set up procedures for a systematic collection of information about adverse drug reactions, and the first pharmacovigilance centres arose. (samedanltd.com)
  • Co-ordination Group for Mutual Recognition and Decentralised Procedures, Human (CMDh) was set up for the review of any issues related to marketing authorisations of medicinal products in two or more Member States in accordance with the mutual recognition procedure or decentralised procedure. (ravimiamet.ee)
  • It is possible for drug safety teams to conduct only the bare minimum pharmacovigilance activities and preserve budget and staffing resources - following only the simplest guidelines of a single market rather than creating a more exacting standard operating procedure (SOP). (pharmaphorum.com)
  • Konstantin V. Balakin is Head of the Laboratory of Information Technology in Medicinal Chemistry at the Institute of Physiologically Active Compounds at the Russian Academy of Sciences. (wiley.com)
  • He is also Director of the scientific consortium ""Orchemed"" (Organic Chemistry and Medicine), which currently includes 11 Russian academic institutes working in the field of organic, medicinal and biological chemistry, and drug discovery. (wiley.com)
  • Practical techniques in Industrial/Medicinal Chemistry, BL4217, MSc Industrial pharmaceutics. (uclan.ac.uk)
  • A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under his direct personal responsibility. (europa.eu)
  • Pharmacovigilance and drug safety management measures have subsequently evolved, as reflected by industry systems for reporting adverse reactions and by the latest legislation introduced in the European Union (EU) in 2012. (samedanltd.com)
  • As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). (pharmaceuticalconferences.com)
  • This excludes medicinal products as defined by Directive 2001/83/EC, pharmaceutical preparations, mixtures, natural products, and other preparations that contain scheduled substances and are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means. (bfarm.de)