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Communicating and Negotiating with FDA: Medical Devices · LearnSpace
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Communicating and Negotiating with FDA: Medical Devices

Курс от University of California, Santa Cruz
Средний≈ 6.5 чАнглийский
О курсеНавыкиПрограммаПреподаватели

О курсе

This course trains regulatory professionals in how to communicate strategically and effectively with the U.S. Food and Drug Administration (FDA), especially in the context of medical device development. While the FDA is not a negotiator in the conventional sense, interactions with the Agency require scientific framing, structured reasoning, and ethical persuasion. Through real-world scenarios, document analysis, and structured assignments, learners will develop the judgment needed to prepare for pre-submission meetings, frame effective regulatory questions, respond to inspections or enforcement actions, and escalate disagreements professionally and appropriately. The course emphasizes the FDA's public health mission, legal boundaries, and internal review logic, focusing on what can be influenced, what cannot, and how to operate effectively within that structure.

Навыки, которые вы освоите

Medical DevicesNegotiationCommunication StrategiesRegulatory ComplianceCrisis ManagementStrategic CommunicationHealth Care Procedure and RegulationStakeholder CommunicationsRegulatory AffairsRegulation and Legal ComplianceHealthcare Industry KnowledgeHealth And Safety StandardsWritingStrategic Decision-MakingCommunicationStrategic ThinkingTechnical CommunicationRisk ManagementBusiness WritingHealth Policy

Программа курса

5 модулей · 38 учебных материалов

01FDA Is Not a Negotiator — But Judgment Is Required9 материалов
🎥 FDA’s Mission and RoleВидео🎥 FDA Structure and Legal AuthorityВидео🎥 Risk-Based Device Classification & PathwaysВидео🎥 FDA’s Discretion and Judgment Calls Видео🎥 Strategic Communication with the FDA

Учитесь у экспертов

Jay Vaishnav

Преподаватель курса

Communicating and Negotiating with FDA: Medical Devices
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Обучение откроется на Coursera
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Обучение на Coursera

≈ 6.5 ч

5 модулей

Язык: Английский

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Видео
📚 Module 1 ResourcesЧтение
🎭 Regulatory Strategy Under Market Pressure: NeuroVista Stroke AssistDIALOGUE
✍️ NeuroVista Case Study: FDA Authority and Device ClassificationЗадание
🔐 Feedback: NeuroVista Case Study: FDA Authority and Device ClassificationЧтение
02Communication as Strategy7 материалов
🎥 Communication as a Strategic ToolВидео🎥 Crafting Clear Written CommunicationsВидео🎥 Effective Verbal Communication in FDA MeetingsВидео🎥 Navigating Disagreement and AdvocacyВидео📚 Module 2 ResourcesЧтение✍️ NeuroVista Case Study: Communication as StrategyЗадание🔐 Feedback: NeuroVista Case Study: Communication as StrategyЧтение
03Preparing for FDA Meetings — Internal and External9 материалов
🎥 FDA Meetings Are Decision EventsВидео🎥 Internal Preparation — Before FDA Ever Sees YouВидео🎥 Framing Questions the FDA Can Actually AnswerВидео🎥 Conducting the Meeting — Execution MattersВидео🎥 After the Meeting — The Work Isn’t OverВидео📚 Module 3 ResourcesЧтение✍️ NeuroVista Case Study: FDA MeetingsЗадание🔐 Feedback: NeuroVista Case Study FDA MeetingsЧтение🎭 NeuroVista Pre-Sub SimulationDIALOGUE
04FDA Inspections in the QMSR Era — BIMO, OII, and Enforcement Response6 материалов
🎥 FDA Inspections Today: OII, BIMO, and QMSRВидео🎥 BIMO Inspections — Clinical OversightВидео🎥 QMSR-Based Inspections — What Changed and What Didn’tВидео🎥 Behavior During Inspection + 483 and Warning LettersВидео📚 Module 4 ResourcesЧтение✍️ NeuroVista Case Study: FDA Inspections in the QMSR EraЗадание
05 Dispute Resolution, Crisis Planning, and Advisory Committee Meetings7 материалов
🎥 Breaking an Impasse – FDA Dispute ResolutionВидео🎥 Planning for Crisis – Regulatory Crisis ManagementВидео🎥 FDA Advisory Committees – Overview and StructureВидео🎥 Preparing for an FDA Advisory Committee MeetingВидео📚 Module 5 ResourcesЧтение✍️ NeuroVista Case Study: Dispute Resolution, Crisis Planning, and Advisory Committee MeetingsЗадание🔐 Feedback: NeuroVista Case Study Dispute Resolution, Crisis Planning, and Advisory Committee MeetingsЧтение