
Scientific Advice by the National and European Approval Form
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People also ask
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What does EMA stand for in science?
Ecological momentary assessment (EMA) involves repeated sampling of subjects' current behaviors and experiences in real time, in subjects' natural environments. EMA aims to minimize recall bias, maximize ecological validity, and allow study of microprocesses that influence behavior in real-world contexts.
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What is the equivalent of FDA in Europe?
The European Commission, the European Medicines Agency (EMA) and the United States of America (USA) Food and Drug Administration (FDA) work together in many areas, streamlining efforts, sharing best practices and aiming to avoid duplication to promote human and animal health.
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What is the European scientific advice mechanism?
The Scientific Advice Mechanism provides independent scientific evidence and policy recommendations to the College of European Commissioners on any subject, including on policy issues that the European Parliament and the Council consider to be of major importance.
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What does EMA approval mean?
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
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Which are scientific committees for the EMA?
EMA's committees Committee for Medicinal Products for Human Use (CHMP) Pharmacovigilance Risk Assessment Committee (PRAC) Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Orphan Medicinal Products (COMP) Committee on Herbal Medicinal Products (HMPC) Committee for Advanced Therapies (CAT)
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What is scientific advice in EMA?
The provision of scientific advice for medicines and medical devices. For medicines, the European Medicines Agency advises on the appropriate tests and studies required in the development or quality of a medicine.
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What is early scientific advice?
It provides biopharmaceutical companies with the opportunity to ask questions about: The appropriateness of their clinical trial design and evidence-generation plan. Real-world evidence (RWE) generation activities to inform the final data package to support both marketing authorization and reimbursement decisions.
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What is a scientific advice meeting?
US Food and Drug Administration Scientific advice meetings allow the FDA to see the scope of the request and allows the FDA to ensure sufficient expertise is available.
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