Qualified Person For Pharmacovigilance

	Qualified Person For Pharmacovigilance {{Distinguish, Qualified person (European Union) In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No 726/2004. The article establishes that the holder of a marketing authorization for a drug for human use must have a QPPV. When a company submits an application for permission to bring a medicinal product onto the market, the company submits a description of its system for monitoring the safety of the product in actual use (a pharmacovigilance system) and proof that the services of a QPPV are in place. "The holder of an authorisation for a medicinal product for human use granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropria ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Pharmacovigilance Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), 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: (Greek for drug) and (Latin for to keep watch). 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 (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). 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 ev ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a '' sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to act ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Professional Certification Professional certification, trade certification, or professional designation, often called simply ''certification'' or ''qualification'', is a designation earned by a person to assure qualification to perform a job or task. Not all certifications that use post-nominal letters are an acknowledgement of educational achievement, or an agency appointed to safeguard the public interest. Overview A certification is a third-party attestation of an individual's level of knowledge or proficiency in a certain industry or profession. They are granted by authorities in the field, such as professional societies and universities, or by private certificate-granting agencies. Most certifications are time-limited; some expire after a period of time (e.g., the lifetime of a product that required certification for use), while others can be renewed indefinitely as long as certain requirements are met. Renewal usually requires ongoing education to remain up-to-date on advancements in the field, evid ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Medical Credentials Healthcare professional credentials are credentials awarded to many healthcare practitioners as a way to standardize the level of education and ability to provide care. Clinicians * Physician Bachelor of Medicine, Bachelor of Surgery (MBBS) Doctor of Medicine (M.D.) ** Doctor of Osteopathic Medicine (D.O.) * Dentist Bachelor of Dental Surgery (BDS) Doctor of Dental Medicine (DMD) ** Doctor of Dental Surgery (DDS) * Optometrist ** Doctor of Optometry (OD) * Podiatrist ** Doctor of Podiatry (DPM) * Chiropractor ** Doctor of Chiropractic (DC) * Physician Assistant (PA) Doctor of Medical Science (D.Med.Sc.), (D.M.Sc.) Master of Medical Science (M.Med.Sc), (M.M.Sc.) Master of Physician Assistant Studies (M.P.A.S.) Professional (Second-entry) Bachelor of Science in Physician Assistant (B.Sc.PA.), (B.H.Sc.PA) * Pharmacist (R.Ph.) Doctor of Pharmacy (PharmD) Master of Pharmacy (MPharm) *Bachelor of Pharmacy (B.Pharm) Medical Researchers Philosop ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Pharmacovigilance Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), 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: (Greek for drug) and (Latin for to keep watch). 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 (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). 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 ev ... [...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]
	Clinical Research Ethics Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Governance Most directly a local institutional review board oversees the clinical research ethics of any given clinical trial. The institutional review board understands and acts according to local and national law. Each countries national law is guided by international principles, such as the Belmont Report's directive that all study participants have a right to "respect for persons", "beneficence", and "justice" when participating in clinical research. Study participant rights Participants in clinical research have rights which they should expect, including the following: right to informed consent shared decision-making privacy for research participants return of results right to withdraw Vulnerable populations There is a range of autonomy which study participants ... [...More Info...] [...Related Items...] OR:* [Wikipedia] [Google] [Baidu]
	Pharmaceuticals Policy Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Funding of research in the life sciences In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH into ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Health Care Quality Health care quality is a level of value provided by any health care resource, as determined by some measurement. As with quality in other fields, it is an assessment of whether something is good enough and whether it is suitable for its purpose. The goal of health care is to provide medical resources of high quality to all who need them; that is, to ensure good quality of life, cure illnesses when possible, to extend life expectancy, and so on. Researchers use a variety of quality measures to attempt to determine health care quality, including counts of a therapy's reduction or lessening of diseases identified by medical diagnosis, a decrease in the number of risk factors which people have following preventive care, or a survey of health indicators in a population who are accessing certain kinds of care. Definition Health care quality is the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes. Quality of care p ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]