Division of Establishment Support
Spanish translation: planificación de necesidades/recursos de distribución
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| 12:11 Sep 25, 2020 |
| English to Spanish translations [PRO] Medical - Medical (general) / Oftalmología | |||||||
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|  Selected response from: Antonella Perazzoni Argentina Local time: 12:17 | ||||||
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| 3 | planificación de necesidades/recursos de distribución |
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Answers
2 hrs confidence: 
| division of establishment support planificación de necesidades/recursos de distribución Explanation: Versión extendida del proceso de planificación de necesidades de distribución (DRP-I) que incluye la provisión de recursos clave no inventarios como mano de obra, instalaciones de manejo de materiales y espacio de almacenamiento. https://diccionariodenegocios.com/p/planificacion-de-recursos-de-distribucion-drp-ii/ https://es.wikipedia.org/wiki/Planeaci%C3%B3n_de_los_Recursos_de_Distribuci%C3%B3n#:~:text=Planificaci%C3%B3n%20de%20los%20Recursos%20de,de% |
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Reference comments
30 mins |
| Reference: Refs. Reference information: Vietnam https://dmec.moh.gov.vn/documents/10182/14453725/upload_0001... Page 8 (Signed): CDR Cesar A. Perez, PhD, Director *** DRP2: Division of Establishment Support*** Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health (Centro de Dispositivos y Salud Radiológica) U.S. Food and Drug Administration, DHHS (Administración de Alimentos y Drogas EE.UU.) https://www.fda.gov/media/135781/download -------------------------------------------------- Note added at 2 hrs (2020-09-25 14:56:28 GMT) -------------------------------------------------- I have seen Antonella's response. I am doubtful re the proposed answer as your question clearly says "Division of Establishment Support" which appears in the link to follow as a sub-office of the DRP. One would expect the acronym for Division of Establishment Support to be "DES", I guess? I say this in light of this link: https://www.fda.gov/about-fda/cdrh-offices/orp-office-regula... Who We Are The Office of Regulatory Programs within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for developing policy and processes for core regulatory programs and provides programmatic expertise to Offices of Health Technology responsible for performing reviews of products over their total product lifecycle. What We Do Manage the various regulatory programs across OPEQ, while providing high-level programmatic support for device specific offices engaging in total product life cycle review of devices. Provide programmatic expertise, develop policy interpretations and analysis, provide review processes and tools, and address novel or complex policy exceptions for purposes of ensuring consistency among device specific offices. Provide logistical support on document control, automated systems, quality assurance, and corrections to device submissions for device specific offices. Provide support to stakeholders utilizing OPEQ regulatory programs. Office Organization DRP1: Division of Submission Support *******DRP2: Division of Establishment Support******** DRP3: Division of Market Intelligence Contact Us For specific phone numbers and email addresses for each office, see the CDRH Management Directory by Organization. For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at [email protected] or 800.638.2041 or 301.796.7100. ****DRP2: Division of Establishment Support***** Who We Are The Division of Regulatory Programs 2 within the Office of Regulatory Programs within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for establishment support programs, such as the imports, registration and listing, exports, regulatory inspections and audits, and quality and compliance programs. What We Do Develop and implement policy and processes to ensure quality and consistency in assessment of medical devices and manufacturing establishments. Provide programmatic expertise for establishment support programs to industry and FDA staff. Provide support to industry when interfacing with the various establishment support programs. The terminology is confusing! -------------------------------------------------- Note added at 3 hrs (2020-09-25 15:31:00 GMT) -------------------------------------------------- I've just found another link re "DRP-2" and you could probably refer to it as "Establishment Support Division" https://www.linkedin.com/in/cesar-perez-81a46638/ Cesar Perez - Director - FDA | LinkedInwww.linkedin.com › ... Division 2: Establishment Support (DRP2) within the Office of Regulatory Programs (ORP) is responsible for the development and implementation of policies and ... Silver Spring, Maryland - Director - FDA |
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