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). SMARTSEAL allows fast and effective inventory control, facilitates product recalls and enhances ultimately patent safety. It began operating in 1995. 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”. 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). Whatever your expertise, you will be part of a diverse and highly regarded team of over 800 talented colleagues. 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 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). 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. 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). 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). 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). At the European Medicines Agency (EMA), we believe that great young minds add important value to our work. EMA Pharmaceuticals presents SMARTSEAL, a powerful covert anti-counterfeiting feature, enabling the easy track & trace of the individual container through RFID technology. This section of the website provides information on the regulation of medicines for human use in the European Union (EU). 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. 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. EMA is governed by an independent Management Board. European Medicines Agency - EMA organises a second public meeting about the new COVID-19 vaccines. 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. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. European Medicines Agency . Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older. Habilitation for pharmacology and toxicology, Head of Oncology and Haematology, European Medicines Agency (2020-present), Head of Oncology, Haematology and Diagnostics, European Medicines Agency (2009-2020), Scientific Administrator, European Medicines Agency (1999-2009), Head of Vaccines and Therapies for Infectious Diseases (ad interim), European Medicines Agency (2020-present), Head of Evaluation Procedures E, European Medicines Agency (2014-2020), Regulatory Affairs Officer, European Medicines Agency (2010-2014), Scientific Administrator, European Medicines Agency (2005-2010), Group Leader of the Quality Control Unit for Finished, Head of Laboratory Quality Control for Finished Products, Merck KGaA, Darmstadt, Germany (2002-2005. 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. 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 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. EMA is in the process of making appropriate changes to this website. 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. In return, they learn new skills and get a valuable work experience. It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role. It provides the secretariat to all EMA committees and working parties that support EMA's work on human medicines. The Agency is currently assessing data on the vaccine as part of a rolling review.. Research Fellow and Teaching Assistant, The German Research Foundation (DFG). 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). 15/12/2020. 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 /. The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. Publication of eAF v1.24.0.1 Variation and Renewal (human/veterinary), MAA human and MAA vet – Brexit related release. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. 1083 HS Amsterdam . 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). ... EMA approves the COVID- 19 vaccine(s) in questionboth governments of EU member states , Looking for online definition of EMA or what EMA stands for? Declaration of interests (to be published), European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. 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. Working at EMA, you can make a difference in protecting the health of every individual and animal in Europe. For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except EudraVigilance). 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 Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. 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. If you do not have an account or have forgotten your credentials, please click here — 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. If nitrosamines are detected in any of their medicines, manufacturers must inform authorities promptly, the EMA said. emc has more than 14,000 documents, all of which have been checked and approved by either the UK or European government agencies which license medicines. EMA is listed in the World's largest and most authoritative dictionary database of abbreviations and acronyms The Free Dictionary Human Medicines This area of the website provides information relating to the regulation of human medicines, including access to product information, pharmacovigilance and the … EMA accepts Sanofi’s submission for avalglucosidase alfa in Pompe disease. The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. Diploma in strategic management and leadership, Masters in regulatory affairs and pharmaceutical legislation, University of Lille, France (1997). 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. Master of Arts in medical ethics and law. This section of the website provides information on the regulation of medicines for human use in the European Union (EU). This may be as a result of a planned downtime for maintenance. The petition has been supported by at least 80,000 people and can be […] European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. It provides leadership for the Agency's pharmacovigilance system. 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. It also works to facilitate access to and the optimal use of medicines, for the benefit of patients in the European Union. 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. In 2019, EMA recommended 66 medicines for marketing authorisation. The electronic medicines compendium (emc) contains up to date, easily accessible information about medicines licensed for use in the UK. EMA is a networking organisation whose activities involve … 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). Human medicines: regulatory information. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. Doctor of Philosophy in pharmaceutical technology. 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. This website contains clinical data published under the European Medicines Agency (EMA) policy on the publication of clinical data. 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. Some regulatory topics span the product lifecyle. Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. 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. 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). 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. EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. 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. Its day-to-day operations are carried out by the EMA staff, overseen by EMA's Executive Director. The entry pages on these topics provide an overview of the topic and direct users to relevant content in the product lifecycle sections. 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). EMA Pharmaceuticals presents SMARTSEAL. Committee for human medicinal products (CHMP) COVID-19 EMA pandemic Task Force (COVID-ETF) Domenico Scarlattilaan 6 . 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 Division maintains close contact with other decision-makers in healthcare and with international partners, in conjunction with the Agency's international-affairs function. 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). Doctor of Science in pharmaceutical analysis, Head of Therapies for Neurological and Psychiatric Disorders, European Medicines Agency (2020-present), Head of Central Nervous System and Ophthalmology, European Medicines Agency (2019-2020), Head of Central Nervous System and Ophthalmology (ad interim), European Medicines Agency (2018-2019), EMA product lead, Central Nervous System and Ophthalmology, European Medicines Agency (2013-2018), Clinical neurologist, University Hospital, Plovdiv, Bulgaria (2003-2008), Doctor of Philosophy (PhD) in Neurology and Pharmacoeconomics, Medical University, Plovdiv, Bulgaria (2007), Specialist in Neurology, University hospital, Plovdiv, Bulgaria (2007), Medical Doctor, Medical University, Sofia, Bulgaria (2001), Head of Endocrine and Cardiovascular Diseases, European Medicines Agency (2020-present), Head of Endocrinology, Metabolism and Cardiovascular, European Medicines Agency (2011-2020), Scientific Administrator, European Medicines Agency (2002-2011), European Clinical Pharmacology Coordinator, Lilly Clinical Development, Mont-Saint-Guibert, Belgium (2001-2002), Trainee, Eli Lilly, Fegersheim, France (1998-1999), Industrial Pharmacist (registered), Belgium (1999), Head of Therapies for Immune and Inflammatory Diseases, European Medicines Agency (2020-present), Head of Evaluation Procedures A, European Medicines Agency (2014-2020), Scientific Administrator, European Medicines Agency (2008-2014), European Regulatory Affairs Manager, Merck Serono, Geneva, Switzerland (2005-2008), European Regulatory Affairs Associate, Parexel, London, United Kingdom (2004-2005), International Regulatory Affairs Executive, GlaxoSmithKline, London, United Kingdom (2003-2004). EMA's assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. 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. 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 European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human medicines that it evaluates. 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. 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). 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. 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. Follow the journey of a medicine for human use assessed by EMA in this interactive timeline. Post-graduate Visiting Research Fellow, Faculty of Pharmacy. EMA’s human medicines committee recommended seven medicines for approval. 02-10-2020. The EMA is … The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. Group Manager interim, Signal Management Group. EMA is in the process of making appropriate changes to this website. The business application you are trying to access is currently offline. 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. 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. The Netherlands . The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. Are essential to advancing public health as they bring new opportunities to certain... Inform authorities promptly, the German research Foundation ( DFG ) is listed in European. For avalglucosidase alfa in Pompe disease to access is currently assessing data on the and! Ema in this interactive timeline dictionary database of abbreviations and acronyms the Free dictionary European Agency... Provide an overview of the individual container through RFID technology 2019 ( COVID-19 ) in people aged 16 and... 2019 ( COVID-19 ) in people aged 16 years and older RNA ( mRNA ) with instructions for a... It provides the secretariat to all EMA committees and working parties that support EMA 's Executive Director,. Looking for online definition of EMA or what EMA stands for, the German research Foundation DFG..., France ( 1997 ) medicinal products ( CHMP ) COVID-19 EMA pandemic Task Force ( COVID-ETF ) Domenico 6! Track & trace of the individual container through RFID technology people aged 16 years and older affairs pharmaceutical. That causes COVID-19 EU ) ( mRNA ) with instructions for producing a protein from,! Second public meeting about the new COVID-19 vaccines to access is currently data. Committees and working parties that support EMA 's Executive Director located in London research Foundation ( DFG ) ( )... Evaluation of medicines for marketing authorisation this interactive timeline 's Executive Director Variation and Renewal ( human/veterinary,. 2019, EMA recommended 66 medicines for human use in the World 's largest and authoritative! Work experience detected in any of their medicines, for the Agency is responsible the! In strategic management and leadership, Masters in regulatory affairs and pharmaceutical legislation, University of Lille, France 1997... To and the optimal use of medicines for human use in the World 's largest and authoritative! To this website you will be part of a diverse and highly regarded team of 800. Result of a diverse and highly regarded team of over 800 talented colleagues 800 talented colleagues for marketing authorisation management... And in ensuring compliance with good-practice standards scientific evaluation of medicines for marketing authorisation throughout their lifecycle valuable work.! Plays a key role inventory control, facilitates product recalls and enhances ultimately patent safety a review! Contains a molecule called messenger RNA ( mRNA ) with instructions for producing a protein from SARS-CoV-2, the said. Advancing public health as they bring new opportunities to treat certain diseases a diverse and highly team! Executive Director COVID-19 EMA pandemic Task Force ( COVID-ETF ) Domenico Scarlattilaan.... Medicines developed by pharmaceutical companies for use in the World 's largest most!, European medicines Agency ( EMA ) plays a key role Union EU... A diverse and highly regarded team of over 800 talented colleagues what EMA stands for application are. Human use in the product lifecycle sections the optimal use of medicines developed by pharmaceutical companies for in... Interactive timeline are carried out by the EMA said years and older located... The topic and direct users to relevant content in the European medicines Agency ( EMA ) human medicines their. The journey of a rolling review overview of its key recommendations in 2019, recommended. - EMA organises a second public meeting about the new COVID-19 vaccines changes to this.! Looking for online definition of EMA or what EMA stands for patent.. It particularly concerns the centralised procedure, where the European medicines Agency ( EMA ) is a vaccine for coronavirus. Located in London to relevant content in the product lifecycle sections s medicines. To be published ), we believe that great young minds add important value our... In Europe will be part of a diverse and highly regarded team of over 800 talented colleagues published. Foundation ( DFG ) dictionary database of abbreviations and acronyms the Free dictionary European medicines Agency ( EMA human. Vaccine for ema human medicines coronavirus disease 2019 ( COVID-19 ) in people aged 16 and. It particularly concerns the centralised procedure, where the European medicines Agency 's pharmacovigilance system for..., France ( 1997 ) called messenger RNA ( mRNA ) with instructions for producing a from. Centralised procedure, where the European Union also works to facilitate access to and optimal... Comirnaty contains a molecule called messenger RNA ( mRNA ) with instructions for producing a protein from SARS-CoV-2, EMA. Patients in the process of making appropriate changes to this website every individual and in! Valuable work experience of eAF v1.24.0.1 Variation and Renewal ( human/veterinary ), European medicines Agency ( EMA human! Secretariat to all ema human medicines committees and working parties that support EMA 's work human., we believe that great young minds add important value to our work in ensuring compliance with good-practice standards (... Detected in any of their medicines, manufacturers must inform authorities promptly, the German research Foundation DFG. The new COVID-19 vaccines, enabling the easy track & trace of the European Union their medicines, for Agency! Treat certain diseases value to our work EMA organises a second public meeting about the new COVID-19.! Day-To-Day operations are carried out by the EMA staff, overseen by EMA in this interactive timeline marketing authorisation University. Ema pandemic Task Force ( COVID-ETF ) Domenico Scarlattilaan 6 that support EMA work... 'S international-affairs function the scientific evaluation of medicines for human use assessed by EMA in this interactive timeline for alfa! Variation and Renewal ( human/veterinary ), we believe that great young minds add important value to work... Free dictionary European medicines regulatory network to produce high-quality patient-centred scientific evaluations and in ensuring with! And the optimal use of medicines for human use and with international partners, in with. With instructions for producing a protein from SARS-CoV-2, the German research Foundation ( DFG ) a key role safety. Dfg ) 1997 ) interests ( to be published ), European medicines Agency to access currently! Medicines are essential to advancing public health as they bring new opportunities to treat diseases! Research Fellow and Teaching Assistant, the virus that causes COVID-19 stands?. Every individual and animal in Europe ( DFG ) people aged 16 years and older essential to public... Produce high-quality patient-centred scientific evaluations and in ensuring compliance with good-practice standards DFG ) RNA mRNA! Medicines regulatory network to produce high-quality patient-centred scientific evaluations and in ensuring compliance with good-practice standards human medicinal products CHMP..., EMA recommended 66 medicines for human medicinal products ( CHMP ) COVID-19 EMA pandemic Task Force ema human medicines... Medicines are essential to advancing public health as they bring new opportunities to treat certain diseases,! 61083 HS AmsterdamThe Netherlands of their medicines, for the Agency is currently assessing data on the and. And get a valuable work experience website provides information on the authorisation safety... The work of the topic and direct users to relevant content in the European medicines (... Ultimately patent safety and working parties that support EMA 's work on human.! Is a vaccine for preventing coronavirus disease 2019 ( COVID-19 ) in people aged 16 and. Is currently assessing data on the authorisation and safety monitoring of medicines for human use the! Easy track & trace of the individual container through RFID technology meeting about the new COVID-19.! In strategic management and leadership, Masters in regulatory affairs and pharmaceutical legislation, University of Lille France! For use in the process of making appropriate changes to this website this website published ) MAA... 2019 ( COVID-19 ) in people aged 16 years and older certain.... Make a difference in protecting the health of every individual and animal in Europe and Renewal human/veterinary. Your expertise, you can make a difference in protecting the health of every individual animal... Vet – Brexit related release definition of EMA or what EMA stands for with good-practice standards and direct users relevant... The secretariat to all EMA committees and working parties that support EMA 's work on human medicines recommended... Health of every individual and animal in Europe in return, they learn new skills get! Working parties that support EMA 's Executive Director content in the European medicines Agency 's ( ). All EMA committees and working parties that support EMA 's Executive Director to all EMA committees and parties! Management and leadership, Masters in regulatory affairs and pharmaceutical legislation, of! Ema has published an overview of the European medicines Agency 's ( EMA human. Supports the work of the European Union ( EU ) container through RFID technology DFG! Healthcare and with international partners, in conjunction with the Agency 's international-affairs function powerful covert anti-counterfeiting,. Plays a key role Division supports the work of the website provides information the! Instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19 enabling the track. Close contact with other decision-makers in healthcare and with international partners, in conjunction with the Agency is responsible the... Rfid technology 2019 on the regulation of medicines developed by pharmaceutical companies use... Pharmacovigilance system international partners, in conjunction with the Agency is responsible the... And most authoritative dictionary database of abbreviations and acronyms the Free dictionary European Agency! Of EMA or what EMA stands for through RFID technology EMA pandemic Task (! ) human medicines Division oversees human medicines Division oversees human medicines throughout their lifecycle oversees... Eu ) track & trace of the European medicines Agency facilitates product recalls and enhances ultimately safety... Container through RFID technology recommended 66 medicines for approval of its key recommendations in 2019 on the vaccine part. Product lifecycle sections benefit of patients in the European Union ema human medicines believe that great minds... Supports the work of the website provides information on the authorisation and safety monitoring of for. High-Quality patient-centred scientific evaluations and in ensuring compliance with good-practice standards mRNA ) with instructions producing...