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Medicines And Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for Bio ...
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Department Of Health And Social Care
The Department of Health and Social Care (DHSC) is a department of His Majesty's Government responsible for government policy on health and adult social care matters in England, along with a few elements of the same matters which are not otherwise devolved to the Scottish Government, Welsh Government or Northern Ireland Executive. It oversees the English National Health Service (NHS). The department is led by the secretary of state for health and social care with three ministers of state and three parliamentary under-secretaries of state. The department develops policies and guidelines to improve the quality of care and to meet patient expectations. It carries out some of its work through arms-length bodies (ALBs), including executive non-departmental public bodies such as NHS England and the NHS Digital, and executive agencies such as the UK Health Security Agency and the Medicines and Healthcare products Regulatory Agency (MHRA). The DHSC also manages the work of the ...
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British Pharmacopoeia Commission
The ''British Pharmacopoeia'' (''BP'') is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing. Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The ''British Pharmacopoeia'' is an important statutory component in the control of medicines, which complements and assists the licensing and inspection processes of the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Together with the ''British National Formulary'' (BNF), the ''British Pharmacopoeia'' defines the UK's pharmaceutical standards. Pharmacopoeial standards are compliance requirements; that is, they provide the means for an independent judgement as to the overall quality of an article, and apply throug ...
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Michael Rawlins
Sir Michael David Rawlins (28 March 1941 – 1 January 2023) was a British clinical pharmacologist and emeritus professor at the University of Newcastle upon Tyne. During his medical career he chaired several executive agencies including the National Institute for Health and Care Excellence (NICE) for 14 years from its formation in 1999 and the Medicines and Healthcare products Regulatory Agency (MHRA) for six years from 2014. From 2012 to 2014 he was president of the Royal Society of Medicine. Rawlins delivered several eponymous lectures during his medical career including the 2008 Harveian Oration at the Royal College of Physicians (RCP), where he argued that there were other ways of collecting useful clinical evidence other than only randomised controlled trials and he encouraged a range of methods to provide a more holistic evaluation. For his contributions to protecting people from the side-effects of medicines he was knighted in 1999, and for his services to the safety o ...
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Sussex Community NHS Foundation Trust
Sussex Community NHS Foundation Trust is a community health trust established as a result of the Transforming Community Services programme. It is the main provider of NHS community health services across West Sussex Brighton and Hove and has an annual budget of £185m. It became an NHS foundation trust in March 2016. Siobhan Melia, has a clinical background having worked as a podiatrist, before moving into senior clinical leadership and managerial roles within the NHS. Siobhan was appointed as the new chief executive of the trust in October 2016 taking over from Paula Head, who was chief executive since January 2013. The trust claims to be the first NHS organisation in Sussex to have achieved accreditation as a ‘Living Wage Employer’, paying its staff a minimum of £7.45 per hour. It runs services at Bognor Regis War Memorial Hospital, Brighton General Hospital, Zachary Merton Hospital in Littlehampton, Arundel and District Hospital, Horsham Hospital and Midhurst Communit ...
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Ian Hudson
Ian Robert Burton Hudson is a British physician and former government official who served as the chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA) from 2013 to 2019. He later became Senior Advisor, Integrated Development, Global Health for the Bill and Melinda Gates Foundation. He was appointed an OBE for services to healthcare in the 2020 New Year Honours. Career Hudson practised as a paediatrician from 1982 to 1989, and then worked in clinical research and development in the pharmaceutical industry, lately as a vice president of SmithKline Beecham, between 1989 and 2001. In 2001 he became director of the licensing division of the then-Medicines Control Agency. He was also the UK delegate to the European Medicines Agency's Committee for Human Medicinal Products, CHMP, (2002-2013), latterly its vice chair and honorary Senior Lecturer in Clinical Pharmacology, William Harvey Research Institute, Queen Mary and Westfield College, university of London (2 ...
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Freedom Of Information In The United Kingdom
Freedom of information legislation in the United Kingdom is controlled by two Acts of the United Kingdom and Scottish Parliaments respectively, which both came into force on 1 January 2005. * Freedom of Information Act 2000 (the "2000 Act") * Freedom of Information (Scotland) Act 2002 ("the 2002 Act" or "the Scottish Act") Certain information can only be obtained under the Environmental Information Regulations 2004. As many public bodies in Scotland (for example, educational bodies) are controlled by the Scottish Parliament, the 2000 Act would not apply to them, and thus a second Act of the Scottish Parliament was required. The acts are very similar but not identical - the types of public bodies covered in England, Wales and Northern Ireland are also covered in Scotland - and the requirements are similar, though the Scottish Act has slightly stronger phrasing in favour of disclosing information. The 2000 Act does not extend to public bodies in the overseas territories or crow ...
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World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of health". Headquartered in Geneva, Switzerland, it has six regional offices and 150 field offices worldwide. The WHO was established on 7 April 1948. The first meeting of the World Health Assembly (WHA), the agency's governing body, took place on 24 July of that year. The WHO incorporated the assets, personnel, and duties of the League of Nations' Health Organization and the , including the International Classification of Diseases (ICD). Its work began in earnest in 1951 after a significant infusion of financial and technical resources. The WHO's mandate seeks and includes: working worldwide to promote health, keeping the world safe, and serve the vulnerable. It advocates that a billion more people should have: universal health care ...
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Bill & Melinda Gates Foundation
The Bill & Melinda Gates Foundation (BMGF), a merging of the William H. Gates Foundation and the Gates Learning Foundation, is an American private foundation founded by Bill Gates and Melinda French Gates. Based in Seattle, Washington, it was launched in 2000 and is reported as of 2020 to be the second largest charitable foundation in the world, holding $49.8 billion in assets. On his 43rd birthday, Bill Gates gave the foundation $1 billion. The primary stated goals of the foundation are to enhance healthcare and reduce extreme poverty across the world, and to expand educational opportunities and access to information technology in the U.S. Key individuals of the foundation include Bill Gates, Melinda French Gates, Warren Buffett, chief executive officer Mark Suzman, and Michael Larson. The BMGF had an endowment of approximately $50 billion . The scale of the foundation and the way it seeks to apply business techniques to giving makes it one of the leaders in venture phila ...
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Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ...
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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 o ...
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Northern Ireland
Northern Ireland ( ga, Tuaisceart Éireann ; sco, label=Ulster Scots dialect, Ulster-Scots, Norlin Airlann) is a part of the United Kingdom, situated in the north-east of the island of Ireland, that is #Descriptions, variously described as a country, province or region. Northern Ireland shares Republic of Ireland–United Kingdom border, an open border to the south and west with the Republic of Ireland. In 2021 United Kingdom census, 2021, its population was 1,903,100, making up about 27% of Ireland#Demographics, Ireland's population and about 3% of the Demography of the United Kingdom#Population, UK's population. The Northern Ireland Assembly (colloquially referred to as Stormont Estate, Stormont after its location), established by the Northern Ireland Act 1998, holds responsibility for a range of Devolution, devolved policy matters, while other areas are reserved for the Government of the United Kingdom, UK Government. Northern Ireland cooperates with the Republic of Irelan ...
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Northern Ireland Protocol
The Protocol on Ireland/Northern Ireland, commonly abbreviated to the Northern Ireland Protocol, is a protocol to the Brexit withdrawal agreement that governs the unique customs and immigration issues at the border on the island of Ireland between the United Kingdom of Great Britain and Northern Ireland and the European Union, and on some aspects of trade in goods between Northern Ireland and the rest of the United Kingdom. Its terms were negotiated shortly before the 2019 general election and concluded immediately after it, in December of that year. The withdrawal agreement as a whole, including the protocol, was ratified in January 2020. The Republic of Ireland–United Kingdom border has had a special status since the thirty-year internecine conflict in Northern Ireland was ended by the Good Friday Agreement of 1998. As part of the Northern Ireland Peace Process, the border has been largely invisible, without any physical barrier or custom checks on its 270 crossing poin ...
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