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32 relations: Bad Pharma, Ben Goldacre, Clinical research associate, Clinical trial, Clinical Trials Directive, Computer, Data monitoring committee, Declaration of Helsinki, Drug development, Ethics, EudraVigilance, European Forum for Good Clinical Practice, European Medicines Agency, European Union, Food and Drug Administration, GxP, Institutional review board, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, International standard, Inverse benefit law, Investigator's brochure, ISO 14155, Medical device, Medical ethics, Ministry of Health, Labour and Welfare, Pharmaceutical industry, Pharmacovigilance, Protocol (science), Quality assurance, Statutory instrument, Unethical human experimentation in the United States, United Kingdom.
Bad Pharma
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients is a book by the British physician and academic Ben Goldacre about the pharmaceutical industry, its relationship with the medical profession, and the extent to which it controls academic research into its own products.
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Ben Goldacre
Ben Michael Goldacre (born 20 May 1974) is a British physician, academic and science writer.
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Clinical research associate
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials.
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Clinical trial
Clinical trials are experiments or observations done in clinical research.
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Clinical Trials Directive
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health.
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Computer
A computer is a device that can be instructed to carry out sequences of arithmetic or logical operations automatically via computer programming.
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Data monitoring committee
A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
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Declaration of Helsinki
The Declaration of Helsinki (DoH) is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA).
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Drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.
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Ethics
Ethics or moral philosophy is a branch of philosophy that involves systematizing, defending, and recommending concepts of right and wrong conduct.
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EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA).
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European Forum for Good Clinical Practice
The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe.
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European Medicines Agency
The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.
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European Union
The European Union (EU) is a political and economic union of EUnum member states that are located primarily in Europe.
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Food and Drug Administration
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
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GxP
GxP is a general abbreviation for the "good practice" quality guidelines and regulations.
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Institutional review board
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical.
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.
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International standard
International standards are standards developed by international standards organizations.
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Inverse benefit law
The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed.
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Investigator's brochure
In drug development, the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.
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ISO 14155
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
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Medical device
A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of.
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Medical ethics
Medical ethics is a system of moral principles that apply values to the practice of clinical medicine and in scientific research.
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Ministry of Health, Labour and Welfare
The is a cabinet level ministry of the Japanese government.
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Pharmaceutical industry
The pharmaceutical industry (or medicine industry) is the commercial industry that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as different types of medicine and medications.
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Pharmacovigilance
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
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Protocol (science)
In the natural sciences a protocol is a predefined written procedural method in the design and implementation of experiments.
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Quality assurance
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering solutions or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled".
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Statutory instrument
In many countries, a statutory instrument is a form of delegated legislation.
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Unethical human experimentation in the United States
Unethical human experimentation in the United States describes numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects.
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United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain,Usage is mixed with some organisations, including the and preferring to use Britain as shorthand for Great Britain is a sovereign country in western Europe.
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Redirects here:
Good Clinical Practice, ICH GCP.
References
[1] https://en.wikipedia.org/wiki/Good_clinical_practice
