EMA’s human medicines committee recommended seven medicines for approval. The Division supports the work of the European medicines regulatory network to produce high-quality patient-centred scientific evaluations and in ensuring compliance with good-practice standards. In return, they learn new skills and get a valuable work experience. The clinical data have been submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure and have been assessed by the Committee for Human Medicinal Products (CHMP). EMA is in the process of making appropriate changes to this website. Doctor of Philosophy in mathematics and physics, Head of Product Portfolio, European Medicines Agency (2020-present), Head of Regulatory Affairs (ad interim), European Medicines Agency (2020), Head of Regulatory Affairs, European Medicines Agency (2014-2020), Regulatory Affairs Adviser, European Medicines Agency (2009-2014), Scientific Administrator, European Medicines Agency (2005-2009), National expert on Secondment, Scientific Administrator, European Medicines Agency (2004-2005), Scientific Administrator, Infarmed, Lisbon, Portugal (2000-2004), Post-graduation degree in Economic Evaluation of Medicines, Instituto Superior de Economia e Gestão e Faculdade de Farmácia da, Degree in Pharmaceutical sciences, Faculdade de Farmácia da, Head of Quality and Safety of Medicines, European Medicines Agency (2020-present), Head of Procedure Management, European Medicines Agency (2013-present), Head of Evaluation Procedures B (ad interim), European Medicines Agency (2017-2018), Head of Chemicals, European Medicines Agency (2012-2013), Scientific Administrator, European Medicines Agency (2002-2012), New Products Development Manager, Famar SA (2000-2002). Its day-to-day operations are carried out by the EMA staff, overseen by EMA's Executive Director. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. Doctor of Philosophy in molecular and cell biology, Head of Labeling, European Medicines Agency (2020-present), Head of Labeling Review and Standards Office, European Medicines Agency (2014-2020), Responsible for the Quality Review of Documents Group Secretariat, European Medicines Agency (2004-2009), Administrator, European Medicines Agency (2001-2004), Research Assistant, Ministry of Interior and Public Administration, Athens, Greece (1994-1995). EMA is a networking organisation whose activities involve … Posted on: 25 September 2019; By: Shalini.Sharma; The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. The electronic medicines compendium (emc) contains up to date, easily accessible information about medicines licensed for use in the UK. EMA Pharmaceuticals presents SMARTSEAL. The EMA's work benefits: 1. patients 2. healthcare professionals 3. academics 4. pharmaceutical companies 5. medicine developers 6. health policymakers.Through its scientific guidelines, scientific advice programme and incentives, it facilitates research into new medicines and encourages development, thereby translating progress in medical science into medicines with real health benefits for patients. Withdrawal of the eAF v1.23.1.3, v1.23.1.4 Variation, Renewal and MAA (human and veterinary) forms from the eAF website however, the forms are accepted by the EMA and NCAs until 31.12.20. Working at EMA, you can make a difference in protecting the health of every individual and animal in Europe. In 2019, EMA recommended 66 medicines for marketing authorisation. Master of Medicine in Pharmaceutical Bioscience, Head of Translational Sciences, European Medicines Agency (2020-present), Head of Science and Innovation Support, European Medicines Agency (2017-2020), Head of Science and Innovation Support (ad interim), European Medicines Agency (2015-2017), Head of Risk Management review (ad interim), European Medicines Agency (2013-2014), Scientific Administrator, European Medicines Agency (2013). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role. Emergency Medical Associates is a physician-led, privately held physician management company that specializes in emergency and hospitalist medicine. European Medicine Agency (EMA) Joint EMAS, IMS and ESSM response to EMA advice regarding high-strength estradiol vaginal creams The European Medicine Agency on October 4th warned both consumers and prescribers against the use of high-strength estradiol creams for longer than 4 weeks. The navigation menu contains three main sections corresponding to the key medicinal product lifecycle stages: Regulatory information on herbal products is in a separate section, as these products are regulated differently in Europe. The EMA operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human and veterinary medicines that it evaluates. For further information on EU legislation and procedures for the regulation of human medicines, see volumes 1-4 and 9-10 of the rules governing medicinal products in the EU. EMA is in the process of making appropriate changes to this website. 02-10-2020. Human medicines: regulatory information. EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the safety of medicines. 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