How to produce quality regulatory documents including the clinical evaluation report (CER)
Customised in-house training course
The content, presenters and format of this course are customised to your requirements.
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 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.
Janette Benaddi (More...)
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 (More...)
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 was EMWA's President for 1 year until May 2020. In addition, she is an Associate Editor of Medical Writing, EMWA’s journal.
This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at firstname.lastname@example.org or contact us below:
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