医学事务：生物制药和医疗器械行业中的医学事务的角色、价值与实践

English | 2023 | ISBN: 1032449470 | 264 pages | True PDF | 112.86 MB

Medical Affairs is one of the three strategic pillars of the pharmaceutical and MedTech industries, but while clear career paths exist for Commercial and Research and Development, there is no formal training structure for Medical Affairs professionals. Medical and scientific expertise is a prerequisite for entry into the function, and many people transitioning into Medical Affairs have advanced degrees such as PhD, MD, or PharmD. However, these clinical/scientific experts may not be especially well-versed in aspects of industry such as the drug development lifecycle, crossfunctional collaborations within industry, and digital tools that are transforming the ways Medical Affairs generates and disseminates knowledge. This primer for aspiring and early-career Medical Affairs professionals equips readers with the baseline skills and understanding to excel across roles.

Features

Defines the purpose and value of Medical Affairs and provides clear career paths for scientific experts seeking their place within the pharmaceutical and MedTech industries. Provides guideance and baseline competencies for roles within Medical Affairs including Medical Communications, Evidence Generation, Field Medical, Compliance, and many others. Specifies the "true north" of the Medical Affairs profession as ensuring patients receive maximum benefit from industry innovations including drugs, diagnostics and devices. Presents the purpose and specific roles of Medical Affairs roles across organization types including biotechs, small/medium/large pharma and device/diagnostic companies, taking into account adjustments in the practic of Medical Affairs to meet the needs of developing fields such as rare disease and gene therapy. Leverages the expertise of over 60 Medical Affairs leaders across companies, representing the first unified, global understanding of the Medical Affairs profession.

医学事务是制药和医疗器械行业的三大战略支柱之一，但与明确的职业路径存在的是市场营销和研发，医疗事务专业人员没有正式的培训结构。进入该功能需要临床/科学专业知识，许多人转行加入医疗事务的专业人士拥有如博士、医生或药剂师等高级学位。然而，这些临床/科学专家可能并不特别熟悉行业方面的事例，包括药物开发生命周期、行业内跨职能合作以及正在重塑医疗事务获取和传播知识方式的数字工具。本文面向有志于成为医疗事务专业人员的人士及其早期职业生涯人士，帮助读者掌握基础技能和理解以胜任各种角色。 特点 定义医学事务的目的及其对制药和医疗器械行业的专家的价值，并为寻求其在该行业中的位置的科学专家提供清晰的职业路径。 为医学事务内的各类角色提供指导和基准能力，包括医疗沟通、证据生成、现场医疗等。 将医学事务的职业定位于确保患者能够从行业创新（如药物、诊断和设备）中获得最大利益。 概述不同类型组织下的医学事务角色及其目的和具体角色。 考虑到临床实践已根据罕见疾病和基因疗法等发展领域进行调整的实际情况，详细说明医学事务角色的目的和职责。 利用60多家公司领导者的专业知识，这是首次全球性的医学事务专业理解。

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