2020-12-25 2021-11-26 , Online Online, 1.790,- € zzgl. MwSt. Barbara Grossman https://www.forum-institut.de/seminar/2111980-writing-for-medical-devices/referenten/21/21_11/2111980-writing-for-medical-devices-clinical-evaluation-english_grossman-barbara.jpg Writing for Medical Devices

The online course will show you how to write scientific and clinical documents such as a technical documentation or clinical evaluation in good and readable English that is appropriate to your audience, while complying with the regulatory requirements.

Topics
  • How to write a scientific document
  • Correct use of language and style
  • What a notified body pays attention to in your clinical evaluation
  • Exercises: Clinical evaluation report (CER) case studies
  • Improving readability - being kind to your reader
  • Essentials of proofreading
Aims and objectives
Our interactive course provides you with a thorough understanding and knowledge of the essential aspects of successful scientific writing.

Based on vivid best practice examples you will learn how to prepare a linguistically and stylistically appropriate document and how to use tables, graphs and flowcharts. Sessions on managing clinical evaluation complete the intensive two-day program.

The course introduces you into issues, best practices and formal requirements of medical and regulatory writing for medical devices.
Who should attend

The course has been designed for professionals responsible for writing and compiling clinical evaluation reports or technical documentation for medical device manufacturers. This includes medical writers at manufacturing companies and service providers preparing clinical evaluation reports or technical documentation for medical device companies.

Both, beginners and professionals, who want to update their knowledge and improve their English writing skills will benefit from this pratical training.

Scientific Writing for Medical Devices

Writing for
Medical Devices

Writing clinical evaluation reports & technical documentation?
Write it right!

Benefits
  • Learn the essential aspects of scientific and medical writing
  • Experienced medical writers and native speakers will answer your questions
  • We are following the IMI quality criteria

Webcode 2111980

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JETZT Buchen

Referenten


Alles auf einen Blick

Termin

25. - 26.11.2021

25. - 26.11.2021

Zeitraum

25th -26th Nov. 2021Day 1: 09:30-17:...

25th -26th Nov. 2021

Day 1: 09:30-17:00
Day 2: 08:30-16:30

You may dial in 30 min before each session.
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Antje Bauer
Conference Manager

+49 6221 500-655
a.bauer@forum-institut.de

Details

The online course will show you how to write scientific and clinical documents such as a technical documentation or clinical evaluation in good and readable English that is appropriate to your audience, while complying with the regulatory requirements.

Topics
  • How to write a scientific document
  • Correct use of language and style
  • What a notified body pays attention to in your clinical evaluation
  • Exercises: Clinical evaluation report (CER) case studies
  • Improving readability - being kind to your reader
  • Essentials of proofreading
Aims and objectives

Our interactive course provides you with a thorough understanding and knowledge of the essential aspects of successful scientific writing.

Based on vivid best practice examples you will learn how to prepare a linguistically and stylistically appropriate document and how to use tables, graphs and flowcharts. Sessions on managing clinical evaluation complete the intensive two-day program.

The course introduces you into issues, best practices and formal requirements of medical and regulatory writing for medical devices.

Who should attend

The course has been designed for professionals responsible for writing and compiling clinical evaluation reports or technical documentation for medical device manufacturers. This includes medical writers at manufacturing companies and service providers preparing clinical evaluation reports or technical documentation for medical device companies.

Both, beginners and professionals, who want to update their knowledge and improve their English writing skills will benefit from this pratical training.

Detailed programme

25th -26th Nov. 2021

Day 1: 09:30-17:00
Day 2: 08:30-16:30

You may dial in 30 min before each session.

Barbara Grossman

Writing and editing documents
  • Content & technical considerations, including:
    • Logic, text flow, length & accuracy
    • Language use, abbreviations and acronyms
    • Preparing a clear message for the intended reader
  • Authorship, including basic principles

Kirsten Sander

Medical writing & the clinical evaluation of a medical device
  • Introduction to the European Medical Device Regulations & guidelines
  • The role of a medical writer in clinical evaluation & the clinical evaluation report (CER)
    • Clinical evaluation vs CER
    • Required knowledge base
    • Authorship
    • The varying responsibilities of the medical writer

Barbara Grossman

Writing regulatory documents
  • Do different audiences & documents require different approaches?
  • Corresponding with authorities

Barbara Grossman

Aspects of English
  • Common errors in English that should be avoided
  • Overview of key punctuation marks & how they affect meaning & readability

Kirsten Sander

Structure & content of the CER
  • Structure of the CER
    • Essential sections: What goes where?
  • Content of the CER
    • 'State of the art' -- the clinical setting
    • 'Performance & safety of the medical device'
    • 'Consider the reader - what the notified body expects
  • What type of writing is needed?
    • High-level review
    • Assessing data quality
  • Source documents & how to acquire them
    • Pre-clinical data: Mode of action & biocompatibility
    • Clinical data: Performance and safety
    • Technical documents
    • Clinical guidelines & the solicited clinical expert statement
    • Industrial & commercial standards such as ISO
  • Safety data

Barbara Grossman

Improving readability -- being kind to your reader
  • Structuring texts
  • Do regulatory documents need to be perfect in terms of language

Kirsten Sander

CER: Systematic literature searches
  • Effective search strategies:
    • Which databases to use
    • How to use them
  • Group exercise
  • Effectiveness of search strategies -- a review of the published evidence
    • Balancing effort (& cost) against outcome

Kirsten Sander

CER case study
  • At least one example on how to produce a CER
    • Deciding on what source data is needed
    • Finding the source data

Kirsten Sander

Introduction to other medical device clinical regulatory documents
  • Post-market clinical follow-up (PMCF): Plan & report
  • Clinical investigation plan
  • Technical documentation & the technical file

Barbara Grossman

Proofreading essentials
  • Final checks -- not just a spellcheck
  • Practicalities, tips & tools

More information

Your take-aways

You will be introduced to the essentials of scientific writing and learn about style and terminology of clinical and regulatory documents. Practical examples will exemplify the topic and your questions will be answered by our extensive experienced experts.

How it works:

  • The online course is live and interactive.
  • Sessions are hosted and controlled directly by our speakers.
  • You may attend the course from anywhere using your preferred device.
  • Please make sure you have a stable internet connection and switch on you camera for a better communication with our experts
  • You can also ask questions live.

Course language

The course language is English. Proficiency in the language is therefore a prerequisite.

This distinguishes our events

Course content: 86% of the participants’ feedback was very good or good. (September 2019)

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