Scientific Writing for Medical Devices
How to produce correct and top-quality scientific documents
- How to write a scientific document
- Correct use of language and style
- What a Notified Body looks for in your clinical evaluation
- Exercises: Clinical Evaluation Report (CER) case study
- Improving readability - being kind to your reader
- Proofreading essentials
Aims and objectives:This interactive course gives you a good understanding of the essential aspects of successful scientifc writing.
You will learn how to prepare a document that is linguistically and stylistically appropriate, using suitable graphical elements such as tables, graphs and flowcharts, based on examples and best practice. Sessions on managing clinical evaluation projects will round off the intensive two-day programme.
This course will familiarise you with organisational issues and best practices in writing for medical devices. You will understand the formal requirements of writing scientifc documents, how they can affect writing style, and the importance of the nuances of language.
This includes medical writers working as employees of manufacturers or as a service-provider preparing a clinical evaluation report or technical documentation in medical device companies.
The practical training will benefit both beginners in scientific writing and those wishing to update their knowledge and improve their English writing skills in this specifc area.
2nd day: 09:00-17:30
- Substantive & technical aspects, including:
- Logic, text flow, wordiness and accuracy
- Details such as language use, abbreviations and acronyms
- Preparing a clear message for the intended reader
11:00 Coffee break
- What are medical devices?
- Introduction to the European medical device regulations and guidelines
- History of the regulations and the current regulatory field
- The regulatory assessors (Notified Bodies)
- EU MDD 1993 (rev. 2007) and EU MDR 2017/745
- EU MEDDEV guidelines
12:30 Lunch break
- How the clinical evaluation and clinical evaluation report (CER) are related and the role of the medical writer
- Clinical evaluation vs CER
- Required knowledge base
- The varying responsibilities of the medical writer
- Do different audiences and documents require different approaches?
- Corresponding with the authorities
15:45 Coffee break
- Common errors in English that should be avoided
- Brief overview of key punctuation points affecting meaning & readability
17:30 End of day 1
- Structure of the CER
- Introduction to medical device clinical evaluation terminology
- What goes where
- Content of the CER
- 'State of the art' - the clinical setting
- 'Performance and safety of the medical device'
- Systematic literature searches: How comprehensive should these be? Which databases should be used?
- 'Consider the reader' - what the notified body expects
- What type of writing is needed?
- Some basic principles
- High-level review
- Assessing data quality
- Technical writing
- Source documents and how to acquire them
- Pre-clinical data: mode of action and biocompatibility
- Clinical data: performance and safety
- Technical documents
- Clinical guidelines and the solicited clinical expert statement
- Industrial and commercial standards such as ISO
- Safety data
10:45 Coffee break
- Structuring texts
- How perfect do regulatory documents need to be in terms of language?
12:30 Lunch break
- Effective search strategies
- Which databases to use
- How to use them
- Effectiveness of search strategies - a review of the published evidence
- Balancing effort (and cost) against outcome
- At least one example on how to produce a CER
- Deciding on what source data is needed
- Finding the source data
- Group exercise
15:30 Coffee break
- Post-marketing clinical follow-up (PMCF): plan and report
- Clinical investigation plan (CIP)
- Clinical investigation report (CIR)
- FMEA report (equivalent to risk management plan)
- Final checks - not just a spellcheck
- Practicalities, tips and tools
17:30 End of course and day 2
As well as a passion for proofreading and quality control, Barbara has more than 20 years' experience of medical writing and editing 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 CRO, working in a wide range of therapeutic areas. Barbara has hands-on experience of preparing a variety of clinical documents, and has managed several large writing programmes. She has presented or run workshops at educational institutions and organisations such as the DIA (Europe and USA), Management Forum and NICE, and led many company-internal training courses. Barbara is a Fellow of EMWA; she has been an EMWA workshop leader since 2001, was Treasurer from 1998 to 2005, has served on the EMWA Professional Development Committee (EPDC) since 2010, and was the Education Officer for 2 years until May 2016. In addition, she is an Associate Editor of Medical Writing, EMWA's journal.
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Gerard Patrick McGregor holds a PhD in Human Physiology and MSc in Physiological Biochemistry. As Medical Writing Consultant and Lead Medical Writer he is responsible for planning, coordinating, and writing of regualtory clinical documents required for submission dossiers seeking marketing approval of newly developed and established pharmaceutical products, and medical devices. Since Since 1980 he published over 100 scientific articles https://www.ncbi.nlm.nih.gov/pubmed/ (listed under "mcgregor-gp")
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Phone: +49 89 909070200
Fax: +49 89 909017 111
High quality scientific writing is crucial for success in research and development and for regulatory documents, both for newbie and experienced professional. Many things depend from ability to effectively communicate research results, such as publishing an article or the number of citations this article receives.
Since the course will be held in English, a good working knowledge of the language is required.
This course is restricted to 15 participants. This limitation, a feature of all FORUM courses, will give participants the opportunity to thoroughly discuss the complex issues addressed in this programme.
We recommend advance registration of at least 30 days.
- You will learn important aspects of writing and interdisciplinary preparation of medical and scientific documents through practical exercises.
- Furthermore, you will also learn about style and terminology for clinical and regulatory documents and will receive tips from experts' practical experience.
Source: The University of Manchester