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Food quality is a concept often based on the organoleptic characteristics and nutritional value of food. Producers reducing potential pathogens and other hazards through food safety practices is another important factor in gauging standards. A food's origin, and even its branding, can play a role in how consumers perceive the quality of products.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
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).
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
The Council for International Organizations of Medical Sciences (CIOMS) is an international non-governmental organization of 40 international, national, and associate member groups representing the biomedical science community. It was jointly established by the World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as a successor to the International Medical Congress that organized 17 conferences from 1867 until the 1913 outbreak of World War One.
Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance centres in regard to the benefits, harm, effectiveness and risks of drugs.
EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
Niaprazine (INN) is a sedative-hypnotic drug of the phenylpiperazine group. It has been used in the treatment of sleep disturbances since the early 1970s in several European countries including France, Italy, and Luxembourg. It is commonly used with children and adolescents on account of its favorable safety and tolerability profile and lack of abuse potential.
David John Finney, was a British statistician and Professor Emeritus of Statistics at the University of Edinburgh. He was Director of the Agricultural Research Council's Unit of Statistics from 1954 to 1984 and a former President of the Royal Statistical Society and of the Biometric Society. He was a pioneer in the development of systematic monitoring of drugs for detection of adverse reactions. He turned 100 in January 2017 and died on 12 November 2018 at the age of 101 following a short illness.
The International Society for Pharmacoepidemiology (ISPE) is a society focused on the practice of pharmacoepidemiology.
Pharmacoepidemiology is the study of the uses and effects of drugs in well-defined populations.
Expert Opinion on Drug Safety is an international peer-reviewed medical journal publishing review articles on all aspects of pharmacovigilance and original papers on the clinical implications of drug treatment safety issues. It was established in 2002 and is published by Informa. The editor-in-chief is Roger McIntyre.
Syed Ziaur Rahman is a permanent member of 'Board of Trustees' and Chair of the Advisory Council, International Association of Medical Colleges (IAOMC). He also serves as elected secretary of IAOMC and Society of Pharmacovigilance, India (SoPI).
Pharmaceutical medicine is a medical discipline concerned with the discovery, evaluation, registration, monitoring and clinical aspects of pharmaceutical development. All medical specialties overlap to some extent, and likewise the boundaries of pharmaceutical medicine are elastic. But, at its centre is the clinical testing of medicines, translation of pharmaceutical drug research into new medicines, safety and well-being of patients and research participants in clinical trials, and understanding the safety profile of medicines and their benefit-risk balance. Pharmaceutical physicians work in the pharmaceutical industry, universities / medical schools, drug regulatory authorities and contract research organisations, but have a close affinity with their medical colleagues elsewhere.
The Society of Pharmacovigilance, India (SoPI), is an Indian national non-profit scientific organisation, which aims at organizing training programmes and providing expertise in pharmacovigilance and enhance all aspects of the safe and proper use of medicines
VigiBase is a World Health Organization's (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO's international drug monitoring programme. It is the single largest drug safety data repository in the world. Since 1978, the Uppsala Monitoring Centre on behalf of WHO, have been maintaining VigiBase. Vigibase is used to obtain the information about a safety profile of a medicinal product. These data are used by pharmaceutical industries, academic institutions and regulatory authorities for statistical signal detection, updating periodic reports, ICSR comparisons with company databases and studying the reporting patterns. The data is collected from each of its 110 member states which currently comprises to over 10 million ICSRs. About a hundred thousand ICSRs are added each year.
Drug Safety is a peer-reviewed medical journal covering pharmacoepidemiology and pharmacovigilance. It was established in 1986 as Medical Toxicology, and was renamed Medical Toxicology and Adverse Drug Experience in 1987. It obtained its current name in 1990. It is published by Springer Nature under the Adis Reprint, and is the official journal of the International Society of Pharmacovigilance. The editor-in-chief is Nitin Joshi. According to the Journal Citation Reports, the journal has a 2022 impact factor of 4.2.
Joerg Hasford is a German physician, biometrician, and epidemiologist. He is emeritus professor in the Institute for Medical Informatics, Biometry and Epidemiology at Ludwig Maximilian University of Munich, chair of the Ethics Committee of the Physicians’ Chamber of the Free State of Bavaria, president of the Association of the Research Ethics Committees in Germany and a member of the Expert Group on Clinical Trials of the European Commission. He has been influential in the study of safety of drugs and pharmacoepidemiology. He was one of the first biostatisticians to look at reliably compiled drug dosing history data in light of pharmacometric consequences. He is the namesake of the Hasford Score, a prognostic score for chronic myeloid leukemia.
Alexander Nii Oto Dodoo, is a Ghanaian pharmacist and academic. He is a clinical pharmacologist and a professor at the Centre for Tropical Clinical Pharmacology, University of Ghana Medical School. He is also the director of the World Health Organization (WHO) Collaborating Centre for Advocacy and Training in Pharmacovigilance. He has been serving as the Director-General of Ghana Standards Authority since 2017.
The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems. The Central Drugs Standard Control Organisation established the program in July 2010 with All India Institute of Medical Sciences, New Delhi as the National Coordination Centre, which later shifted to Indian Pharmacopoeia Commission in Ghaziabad on 15 April 2011.
References
- ↑ "Resources - Drug Safety, ISoP official journal" . Retrieved 2023-07-17.
