EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. It also works to facilitate access to and the optimal use of medicines, for the benefit of patients in the European Union. This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market. Its day-to-day operations are carried out by the EMA staff, overseen by EMA's Executive Director. 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). Emergency Medical Associates is a physician-led, privately held physician management company that specializes in emergency and hospitalist medicine. Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older. The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. At the European Medicines Agency (EMA), we believe that great young minds add important value to our work. Follow the journey of a medicine for human use assessed by EMA in this interactive timeline. It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role. Bachelor of Medicine, Surgery and Obstetrics, and Bachelor of Arts, Head of Signal and Incident Management, European Medicines Agency (2016-2020), Head of Signal Management, European Medicines Agency (2013-2016), Head of Signal Detection and Data Analysis, European Medicines Agency (2012-2013), Head of Signal Detection and Data Analysis (ad interim), European Medicines Agency (2011-2012), Scientific Administrator, European Medicines Agency (2010-2011), Associate Director Global Medical Affairs Immunology, UCB Pharma S.A., Brussels, Belgium (2006-2010), Project Manager, Cardiovascular, Johnson & Johnson Medical, Waterloo, Belgium (2002-2005), Medical Reviewer, Quintiles / Janssen Pharmaceutica N.V., Beerse, Belgium (2000-2002), Clinical Research Associate, Quintiles, Sofia, Bulgaria (1998-2000), Physician, Military Service, Bulgaria (1997-1998), Scientific Administrator, European Medicines Agency (2008-2020), Affiliate Safety Representative / Drug Safety Manager, Abbott Laboratories, Amadora, Portugal (2004-2008), Regulatory Affairs Trainee, GlaxoSmithKline, Algés, Portugal (2003-2004), Degree in Pharmaceutical Sciences, Faculdade de Farmácia da, Head of Committees and Quality Assurance, European Medicines Agency (2020-present), Head of Evaluation Procedures B, European Medicines Agency (2018-2020), Head of Telematics and Governance Office, European Medicines Agency (2017-2018), Head of Telematics Office, European Medicines Agency (2015-2017), Head of Rheumatology, Respiratory, Gastroenterology and Immunology (ad interim), European Medicines Agency (2013-2015), Scientific Administrator, European Medicines Agency (2008-2013), European Regulatory Affairs, Schering-Plough Europe, Brussels, Belgium (2000-2008). Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. The EU Open Data Portal provides, via a metadata catalogue, a single point of access to data of the EU institutions, agencies and bodies for anyone to reuse. The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health. In return, they learn new skills and get a valuable work experience. Research Fellow and Teaching Assistant, The German Research Foundation (DFG). Human medicines: regulatory information. The Agency is currently assessing data on the vaccine as part of a rolling review.. Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. EMA Pharmaceuticals presents SMARTSEAL, a powerful covert anti-counterfeiting feature, enabling the easy track & trace of the individual container through RFID technology. In 2019, EMA recommended 66 medicines for marketing authorisation. Masters degree in international drug development and registration, Head of Advanced Therapies, European Medicines Agency (2020-present), Head of Specialised Scientific Disciplines, European Medicines Agency (2013-2020), Head of Risk Management, European Medicines Agency (2012-2013), Head of Risk Management (ad interim), European Medicines Agency (2011-2012), Head of Signal Detection and Data Analysis, European Medicines Agency (2009-2011), Scientific Administrator, European Medicines Agency (2003-2009), Medical Editor, EuroTransmed, United Kingdom (1998-2003), Scientific Project Manager, Medical Action Communications, United Kingdom (1997-1998), Post-doctoral Researcher, Clinical Research Centre, United Kingdom (1995-1996). It began operating in 1995. 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. If nitrosamines are detected in any of their medicines, manufacturers must inform authorities promptly, the EMA said. SMARTSEAL allows fast and effective inventory control, facilitates product recalls and enhances ultimately patent safety. This website contains clinical data published under the European Medicines Agency (EMA) policy on the publication of clinical data. EMA is listed in the World's largest and most authoritative dictionary database of abbreviations and acronyms The Free Dictionary European Medicines Agency Committee for human medicinal products (CHMP) COVID-19 EMA pandemic Task Force (COVID-ETF) Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands ... EMA approves the COVID- 19 vaccine(s) in question, both governments of EU member states rules governing medicinal products in the EU, Ethical use of animals in medicine testing, Medicines for use outside EU (Article 58), Scientific advice and protocol assistance. Doctor of Philosophy in molecular and cellular pharmacology, Head of Paediatric Medicines, European Medicines Agency (2018-present), Head of Paediatric Medicines (ad interim), European Medicines Agency (2017-2018), Scientific Officer, Paediatric Medicines Office, European Medicines Agency (2007-2016), Lecturer, Paediatric Neurology and Neonatology, Lead Neurodevelopment Service, Children's University Hospital, Technische Universität München (TU Munich), Germany (2001-2007), Research Fellow, Children's University Hospital, TU Munich, Germany (1998-2000), Paediatric training, Children's University Hospital, TU Munich, Germany (1992-1998), Study Delivery Operations Specialist, AstraZeneca R&D Mölndal, Gothenburg, Sweden (2003-2006), Medical writer, Cell Therapeutics Scandinavia AB, Gothenburg, Sweden (2002 - 2003). Committee for human medicinal products (CHMP) COVID-19 EMA pandemic Task Force (COVID-ETF) Domenico Scarlattilaan 6 . Looking for online definition of EMA or what EMA stands for? Masters degree in European judicial studies, Law degree, Democritean University of Thrace, Komotini, Greece (1993), Head of Regulatory Affairs (2020-present), Head of Evaluation Procedures F, European Medicines Agency (2017-2020), Head of Evaluation Procedures F (ad interim), European Medicines Agency (2017), Regulatory Affairs Officer, European Medicines Agency (2009-2017), Regulatory Intelligence Officer, Novartis Pharma (2008-2009), Regulatory Affairs Executive, Leo Pharma (2002-2008). 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. Dr. Wolfgang Wordarg, pulmonologist and former head of a public health department, and Dr. Michael Yeadon, ex-Pfizer research director for respiratory diseases, petitioned the EMA, the European Medicines Agency, on December 1, 2020, to immediately stop clinical trials of the Corona vaccines. Team Leader, Pharmacoepidemiology Research Team, Clinical Research Fellow in Ophthalmic Epidemiology, Institute of Ophthalmology, London, United Kingdom (1996), Junior House Doctor, Dublin, Ireland (1991-1992), Fellowship of the Royal College of Surgeons in Ireland (Ophthalmology), Dublin, Ireland (1995), Fellowship of the Royal College of Ophthalmologists, London, United Kingdom (1995). EMA is in the process of making appropriate changes to this website. EMA accepts Sanofi’s submission for avalglucosidase alfa in Pompe disease. 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. Declaration of interests (to be published), European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. It provides the secretariat to all EMA committees and working parties that support EMA's work on human medicines. 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. The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. This section of the website provides information on the regulation of medicines for human use in the European Union (EU). The Division maintains close contact with other decision-makers in healthcare and with international partners, in conjunction with the Agency's international-affairs function. Human Medicines This area of the website provides information relating to the regulation of human medicines, including access to product information, pharmacovigilance and the … 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. 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). Master of Arts in medical ethics and law. European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. 15/12/2020. EMA is governed by an independent Management Board. EMA’s human medicines committee recommended seven medicines for approval. The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human medicines that it evaluates. For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except EudraVigilance). The EMA is … Doctor of Philosophy in Molecular Pharmacology and Drug Discovery, Head of Inspections, European Medicines Agency (2020-present), Senior Medical Assessor, Product Licensing Assessment Unit and. 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. ... EMA approves the COVID- 19 vaccine(s) in questionboth governments of EU member states , European Medicines Agency - EMA organises a second public meeting about the new COVID-19 vaccines. This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market. The Netherlands . This may be as a result of a planned downtime for maintenance. Working at EMA, you can make a difference in protecting the health of every individual and animal in Europe. 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. EMA's assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. Human medicine European public assessment report (EPAR ... European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The ... EMA is in the process of making appropriate changes to this website. European Medicines Agency . Post-graduate Visiting Research Fellow, Faculty of Pharmacy. Doctor of Philosophy in pharmaceutical technology. The entry pages on these topics provide an overview of the topic and direct users to relevant content in the product lifecycle sections. Master's degree in European regulatory affairs, Head of Meeting Secretariat, European Medicines Agency (2020-present), Head of Working Parties Secretariat (ad interim), European Medicines Agency (2015-2020), Scientific Administrator, European Medicines Agency (2009-2015), Regulatory Affairs Manager, Schering-Plough, Brussels, Belgium (2006-2009), Regulatory Affairs Officer, Baxter, Brussels, Belgium (2003-2006), Trainee, Baxter, Nivelles, Belgium (2003), Deputy Head of Packaging, Schering AG, Lys-lez-Lannoy, France (2000-2003), Deputy Head of Packaging, Laboratoires UPSA, Agen, France (1997-2000), Project team manager, Laboratoires UPSA, Agen, France (1995-1997), Trainee, Laboratoires UPSA, Agen, France (1994-1995), Trainee, Roussel-Uclaf, Paris, France (1991-1992), Hospital pharmacy trainee, Central University Hospitals, Nancy, France (1990-1991), Masters in regulatory affairs and health economy, University of Lille/Paris/Lyon, France (2003), Masters in pharmaceutical manufacturing, University of Bordeaux, France (1994), Doctor of pharmacy specialising in industry, University of Nancy/Bordeaux, France (1996), Head of Procedures, European Medicines Agency (2020-present), Head of Evaluation Procedures D, European Medicines Agency (2014-2020), Scientific Administrator, European Medicines Agency (2006-2014), Business Intelligence Analyst, AstraZeneca, Madrid, Spain (2004-2006), Master in management of pharmaceutical and healthcare industries, Instituto de Empresa, Madrid, Spain (2004). The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. Doctor of Philosophy in biochemistry / molecular biology, Doctor of Pharmacy, University of Nancy, France (1992), Masters degree in biochemistry, University of Nancy, France (1990), Scientific Adviser on Human Medicines, European Medicines Agency (2020-present), Deputy Head of Product Development Scientific Support, European Medicines Agency (2015-2020), Principal Scientific Administrator, European Medicines Agency (1999-2004), Board-certified physician for pharmacology and toxicology, Bavarian Chamber of Physicians, Munich, Germany (1994). This section of the website provides information on the regulation of medicines for human use in the European Union (EU). 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. The electronic medicines compendium (emc) contains up to date, easily accessible information about medicines licensed for use in the UK. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU. 1083 HS Amsterdam . Whatever your expertise, you will be part of a diverse and highly regarded team of over 800 talented colleagues. — EU Medicines Agency (@EMA_News) December 23, 2020 Moderna to be approved in January EMA said, that the application for marketing authorization for the COVID-19 vaccine, developed by Moderna was ongoing and could be concluded at an extraordinary meeting of EMA’s human medicines committee (CHMP) on 6 January 2021. Group Manager interim, Signal Management Group. It provides leadership for the Agency's pharmacovigilance system. Master of Science in industrial pharmacy, Head of Pharmaceutical Quality, European Medicines Agency (2020-present), Quality Specialist and Scientific Secretariat to Biologics, Scientific Administrator in Pre-authorisation, Quality of Medicines, European Medicines Agency (2007-2014), Scientific Administrator in Regulatory Affairs and Post-authorisation Safety /. EMA is in the process of making appropriate changes to this website. The EMA’s human medicines committee said in a press release on 26 September 2019 that it was requesting marketing authorisation holders for human medicines to “test all products at risk … as a matter of precaution”. The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA)… avalglucosidase alfa Endocrinology Europe European Medicines Agency Focus On France Pharmaceutical Pompe disease Rare diseases Regulation Sanofi EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. Deputy Executive Director and support services, European Commission Directorate-General for Research / Biotechnology, European Organisation for Research and Treatment of Cancer, Federal Institute for Drugs and Medical Devices, Universities of Kaiserslautern and Witten-Herdecke, Medicines and Healthcare products Regulatory Agency (MHRA), School of Medicine Trinity College Dublin, London School of Hygiene and Tropical Medicine, Trinity college, the University of Dublin, Translation Centre for the Bodies of the European Union, European Institute of Public Administration, Head of Human Medicines, European Medicines Agency (2020-present), Adviser for Human Medicines, European Medicines Agency (2020), Head of Information Management, European Medicines Agency (2015-2020), Head of Information Management Strategy and Governance (ad interim), European Medicines Agency (2017-present), Head of Project Assurance and Management Service (ad interim), European Medicines Agency (2017-present), Head of Information Technology (ad interim), European Medicines Agency (2015), Head of Procedure Management and Business Support, European Medicines Agency (2013-2015), Head of Quality of Medicines, European Medicines Agency (2010-2013), Head of Product Data Management (ad interim), European Medicines Agency (2009-2010), Scientific Administrator, European Medicines Agency (2004-2009), Scientific Administrator, European Medicines Agency (1999-2002), Research Fellow, INSERM U272 Research Unit, Nancy, France (1990-1992), Hospital Pharmacy Trainee, Central University Hospitals, Nancy, France (1990-1991). EMA Pharmaceuticals presents SMARTSEAL. 02-10-2020. Doctor of Philosophy in clinical research, Head of Scientific Evidence Generation, European Medicines Agency (2020-present), Head of Product Development Scientific Support, European Medicines Agency (2016-2020), Head of Scientific and Regulatory Management, European Medicines Agency (2013-2016), Head of Rheumatology, Respiratory, Gastroenterology and Immunology, European Medicines Agency (2009-2013), Scientific Administrator, European Medicines Agency (2007-2009), Regulatory Project Manager, Roche Products Ltd., Welwyn Garden City, United Kingdom (2003-2006), Drug Regulatory Affairs Manager, Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany (1999-2003), Drug Regulatory Affairs Manager, medac AG, Hamburg, Germany (1998-1999), Scientific Assistant, Institute for Pharmaceutical Technology and Biopharmaceutics, Münster, Germany (1994-1997), Head of Scientific Advice, European Medicines Agency (2020-present), ]Head of Evaluation Procedures C, European Medicines Agency (2014-present), Primary care physician, Ioannina, Greece (1998-2001). 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