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The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. EMA is governed by an independent Management Board. Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. 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). 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). It began operating in 1995. European Medicines Agency . The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. 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 Division maintains close contact with other decision-makers in healthcare and with international partners, in conjunction with the Agency's international-affairs function. 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). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role. Human medicines: regulatory information. EMA is a networking organisation whose activities involve … At the European Medicines Agency (EMA), we believe that great young minds add important value to our work. 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). 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. Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. This website contains clinical data published under the European Medicines Agency (EMA) policy on the publication of clinical data. The European Medicines Agency (EMA) is a decentralised agency of the European Union, located in London. For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except EudraVigilance). Group Manager interim, Signal Management Group. Doctor of Philosophy in pharmaceutical technology. The Netherlands . 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. If you do not have an account or have forgotten your credentials, please click here 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. 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). This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market. Some regulatory topics span the product lifecyle. EMA is listed in the World's largest and most authoritative dictionary database of abbreviations and acronyms The Free Dictionary 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. EMA accepts Sanofi’s submission for avalglucosidase alfa in Pompe disease. 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 in the process of making appropriate changes to this website. ... EMA approves the COVID- 19 vaccine(s) in questionboth governments of EU member states , 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. 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’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. 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. The entry pages on these topics provide an overview of the topic and direct users to relevant content in the product lifecycle sections. 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). 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 Pharmacology and Drug Discovery, Head of Inspections, European Medicines Agency (2020-present), Senior Medical Assessor, Product Licensing Assessment Unit and. European Medicines Agency - EMA organises a second public meeting about the new COVID-19 vaccines. Declaration of interests (to be published), European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. 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. 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). Emergency Medical Associates is a physician-led, privately held physician management company that specializes in emergency and hospitalist medicine. 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. The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. If nitrosamines are detected in any of their medicines, manufacturers must inform authorities promptly, the EMA said. EMA's assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. 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. Master of Arts in medical ethics and law. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. Committee for human medicinal products (CHMP) COVID-19 EMA pandemic Task Force (COVID-ETF) Domenico Scarlattilaan 6 . EMA Pharmaceuticals presents SMARTSEAL. 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 Agency is currently assessing data on the vaccine as part of a rolling review.. 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). 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). The business application you are trying to access is currently offline. 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. 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. It provides leadership for the Agency's pharmacovigilance system. EMA is in the process of making appropriate changes to this website. It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role. 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. Publication of eAF v1.24.0.1 Variation and Renewal (human/veterinary), MAA human and MAA vet – Brexit related release. This may be as a result of a planned downtime for maintenance. — 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. 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 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. 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). It provides the secretariat to all EMA committees and working parties that support EMA's work on human medicines. Its day-to-day operations are carried out by the EMA staff, overseen by EMA's Executive Director. This section of the website provides information on the regulation of medicines for human use in the European Union (EU). Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older. SMARTSEAL allows fast and effective inventory control, facilitates product recalls and enhances ultimately patent safety. Post-graduate Visiting Research Fellow, Faculty of Pharmacy. Whatever your expertise, you will be part of a diverse and highly regarded team of over 800 talented colleagues. The petition has been supported by at least 80,000 people and can be […] 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). Diploma in strategic management and leadership, Masters in regulatory affairs and pharmaceutical legislation, University of Lille, France (1997). 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 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. Research Fellow and Teaching Assistant, The German Research Foundation (DFG). The electronic medicines compendium (emc) contains up to date, easily accessible information about medicines licensed for use in the UK. 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. 1083 HS Amsterdam . 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. 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”. This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market. 02-10-2020. EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. 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). The EMA is … Follow the journey of a medicine for human use assessed by EMA in this interactive timeline. It also works to facilitate access to and the optimal use of medicines, for the benefit of patients in the European Union. 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. 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. The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. 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 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. In return, they learn new skills and get a valuable work experience. 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. 15/12/2020. Looking for online definition of EMA or what EMA stands for? This section of the website provides information on the regulation of medicines for human use in the European Union (EU). In 2019, EMA recommended 66 medicines for marketing authorisation. 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. EMA Pharmaceuticals presents SMARTSEAL, a powerful covert anti-counterfeiting feature, enabling the easy track & trace of the individual container through RFID technology. 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). EMA’s human medicines committee recommended seven medicines for approval. European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. Working at EMA, you can make a difference in protecting the health of every individual and animal in Europe. , in conjunction with the Agency 's pharmacovigilance system of abbreviations and acronyms the dictionary. Other decision-makers in healthcare and with international partners, in conjunction with Agency! Alfa in Pompe disease be published ), we believe that great young add! 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