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.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Mr Barbara Grossman ,
Biochemist ,
Hawkeye Medical LimitedBarbara 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.
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
