DUBLIN--(BUSINESS WIRE)--The 'Medical Writing for Medical Devices Training Course' conference has been added to ResearchAndMarkets.com's offering.

都柏林——（商业新闻短讯）——ResearchAndMarkets.com的产品中增加了“医疗器械写作培训课程”会议。

Writing for medical devices has its own particular skill set and, with important regulatory changes in the industry, all those involved in medical writing face a challenge to ensure they have the necessary expertise and resources to fulfil the requirements of the new regulation.

医疗器械写作有其独特的技能，随着行业监管的重大变化，所有参与医疗器械写作的人都面临着挑战，以确保他们拥有必要的专业知识和资源来满足新法规的要求。

This comprehensive course has been designed to provide you with a thorough understanding of the essential aspects of medical writing, with a particular focus on medical devices.

本综合课程旨在让您彻底了解医学写作的基本方面，尤其是医疗器械。

Under the guidance of our expert trainers, you will learn how to prepare a document that is linguistically and stylistically appropriate and understand the effective use of visual elements such as tables, graphs and flow charts. The programme will examine the content and structure of the CER - an integral part of the submission process, and ensure that you are fully aware of what a Notified Body is looking for in your clinical evaluation..

在我们的专家培训师的指导下，您将学习如何编写语言和风格上合适的文档，并了解如何有效使用表格、图表和流程图等视觉元素。该计划将审查CER的内容和结构，这是提交过程的一个组成部分，并确保您完全了解通报机构在您的临床评估中寻求的内容。。

Practical exercises and discussion will consolidate learning, and helpful tips and techniques from experts in the field of medical writing and medical devices will enhance your knowledge.

实践练习和讨论将巩固学习，来自医学写作和医疗器械领域专家的有用提示和技巧将增强您的知识。

Certifications:

认证：

CPD: 12 hours for your records

CPD：记录12小时

Certificate of completion

竣工证书

Who Should Attend:

参加人员：

Medical device professionals responsible for preparing, writing and completing a CER

负责准备、编写和完成CER的医疗器械专业人员

Medical writers producing reports for medical device manufacturers

为医疗器械制造商撰写报告的医学作家

Regulatory affairs personnel involved in preparing scientific documentation

参与编制科学文件的监管事务人员

Medical device personnel who require a fundamental understanding of what is required when drafting scientific reports for their products

医疗器械人员在为其产品起草科学报告时需要基本了解所需内容

Contract research organisations (CROs)

合同研究组织（CRO）

R&D professionals

研发专业人员

Key Topics Covered:

涵盖的关键主题：

Day 1

第1天

Overview of writing and editing documents

编写和编辑文档概述

Substantive and technical aspects

实质性和技术方面

Considering logic, text flow, wordiness and accuracy

考虑逻辑、文本流、冗长和准确性

Looking at the details such as language editing, abbreviations and acronyms

查看语言编辑、缩写和首字母缩写等细节

Preparing a clear message for the intended reader

为目标读者准备清晰的信息

Regulations applicable to the clinical evaluation of a medical device

适用于医疗器械临床评估的法规

Introduction to the European Medical Device Regulation (MDR)

欧洲医疗器械法规（MDR）简介

Guidance documents for clinical evaluations - what is required?

临床评估指导文件-需要什么？

Notified Body expectations

公告机构期望

Writing regulatory documents

编写规范性文件

Do different audiences and documents require different approaches?

不同的受众和文档是否需要不同的方法？

Corresponding with the authorities

Systematic literature searches for the CER

CER的系统文献检索

Effective search strategies

有效的搜索策略

Deciding on what source data is required

决定需要哪些源数据

State of the art

最新技术

Aspects of English

英语方面

Common errors in English that should be avoided

应避免的英语常见错误

Brief overview of key punctuation points affecting meaning and readability

简要概述影响意义和可读性的关键标点

Day 2

第2天

Improving readability - be kind to your reader

提高可读性-善待读者

Structuring texts

结构化文本

In terms of language, how perfect do regulatory documents need to be?

就语言而言，监管文件需要有多完美？

Structure and content of the CER

CER的结构和内容

What is required to meet the regulation?

符合规定需要什么？

Contents of a CER

CER的内容

Conducting a clinical evaluation

进行临床评估

CER case study workshop

CER案例研究研讨会

Deciding on what source data is needed

决定需要哪些源数据

Introduction to other medical device clinical regulatory documents

其他医疗器械临床规范性文件介绍

PMCF plan and report

PMCF计划和报告

Clinical investigation plan and report

临床调查计划和报告

Proofreading essentials

校对要领

Final checks - not just a spell check

最终检查-不仅仅是拼写检查

Practicalities, tips and tools

实用性、技巧和工具

Key take-home messages

关键回家信息

Speakers:

Barbara Grossman

芭芭拉·格罗斯曼

Biochemist

生物化学家

Hawkeye Medical Limited

鹰眼医疗有限公司

Barbara Grossman has a passion for proofreading, quality control, and education. She is a biochemist by training and a medical writer, editor and teacher by profession, with 20+ years' experience in the pharmaceutical industry. Before starting her own medical writing and consultancy business (Hawkeye Medical Limited), she built up and managed the medical writing group at Covance, the contract research organisation, working in a wide range of therapeutic areas..

芭芭拉·格罗斯曼热爱校对、质量控制和教育。她是一名受过训练的生物化学家，也是一名医学作家、编辑和教师，在制药行业拥有20多年的经验。在开始自己的医学写作和咨询业务（Hawkeye medical Limited）之前，她在合同研究组织Covance建立并管理了医学写作小组，在广泛的治疗领域工作。。

She has given professional development training at educational institutions and organisations such as the DIA (Drug Information Association - Europe and USA), EMWA (European Medical Writers Association) and NICE (National Institute for Health and Care Excellence), and has led many company-internal training courses.

她曾在DIA（欧洲和美国药物信息协会），EMWA（欧洲医学作家协会）和NICE（国家健康与护理卓越研究所）等教育机构和组织接受专业发展培训，并领导了许多公司内部培训课程。

Barbara is an honorary member of EMWA, was Treasurer 1998-2005, has been an EMWA workshop leader since 2001, served on EMWA's Education Committee 2010-2018, was the Education Officer for 2 years until 2016, and since May 2019 is EMWA's President. In addition, she is an Associate Editor of Medical Writing, EMWA's journal..

Barbara是EMWA的荣誉成员，1998-2005年担任财务主管，自2001年起担任EMWA研讨会负责人，2010-2018年在EMWA教育委员会任职，2016年前担任教育官员2年，2019年5月起担任EMWA主席。。。

For more information about this conference visit https://www.researchandmarkets.com/r/19dp59

有关本次会议的更多信息，请访问https://www.researchandmarkets.com/r/19dp59

About ResearchAndMarkets.com

关于ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ResearchAndMarkets.com是全球领先的国际市场研究报告和市场数据来源。我们为您提供有关国际和地区市场、关键行业、顶尖公司、新产品和最新趋势的最新数据。