Medical Writing for Medical Devices

How to produce quality regulatory documents including the clinical evaluation report (CER)

27-28 Feb 2020

& 30 Sep-1 Oct 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 17 Jan

Book now

Course overview

NEW FOR 2020

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.

This comprehensive new 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.

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.

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.

Who should attend?

  • Medical device professionals responsible for preparing, writing and completing a CER
  • Medical writers producing reports for medical device manufacturers
  • Regulatory affairs personnel involved in preparing scientific documentation
  • Medical device personnel who require a fundamental understanding of what is required when drafting scientific reports for their products
  • Contract research organisations (CROs)
  • R&D professionals

Programme day one

Overview of writing and editing documents

  • Substantive and technical aspects
    • Considering logic, text flow, wordiness and accuracy
    • Looking at the details such as language editing, abbreviations and acronyms
    • Preparing a clear message for the intended reader

Regulations applicable to the clinical evaluation of a medical device

  • Introduction to the European Medical Device Regulation (MDR)
  • Guidance documents for clinical evaluations – what is required?
  • Notified Body expectations

Writing regulatory documents

  • Do different audiences and documents require different approaches?
  • Corresponding with the authorities

Systematic literature searches for the CER

  • Effective search strategies
  • Deciding on what source data is required
  • State of the art

Aspects of English

  • Common errors in English that should be avoided
  • Brief overview of key punctuation points affecting meaning and readability

Programme day two

Improving readability – be kind to your reader

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

Structure and content of the CER

  • What is required to meet the regulation?
  • Contents of a CER
  • Conducting a clinical evaluation

Format of a CER

  • Conducting a clinical evaluation

CER case study workshop

  • Deciding on what source data is needed

Introduction to other medical device clinical regulatory documents

  • PMCF plan and report
  • Clinical investigation plan and report

Proofreading essentials

  • Final checks – not just a spell check
  • Practicalities, tips and tools

Key take-home messages

Presenters

Janette Benaddi (27-28 Feb 2020)

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

Barbara Grossman (27-28 Feb 2020)

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. 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. 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.

Book now

27-28 Feb 2020
27-28 Feb 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 17 Jan*
Enrol now
30 Sep-1 Oct 2020
30 Sep-1 Oct 2020 Venue not yet confirmed GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code