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A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
The European Medical Association (EMA) was established by doctors from the 12 member states in 1990 in Belgium, [1] EMA is the main association representing Medical Doctors in Europe, supporting the European Commission - Lifelong Learning Programme (LLP).
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 ).
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice.The EudraGMP system was launched in April 2007, for use by European Medicines Regulators.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
The Heads of Medicines Agencies (HMA) is a network of both the human and veterinary medicines agencies of the European Economic Area. [1]The HMA co-operates with the European Medicines Agency and the European Commission (Directorate-General for Health and Food Safety) in the operation of the European medicines regulatory system.
On 2 December 2020, the MHRA became the first global medicines regulator to approve an RNA vaccine when it gave conditional and temporary authorization to supply for use of the Pfizer–BioNTech COVID-19 vaccine codenamed BNT162b2 [22] [23] [24] (later branded as Comirnaty).
A risk management plan is a document to foresee risks, estimate impacts, and define responses to risks. It also contains a risk assessment matrix.According to the Project Management Institute, a risk management plan is a "component of the project, program, or portfolio management plan that describes how risk management activities will be structured and performed".