Presented by
Management Forum
How to produce quality regulatory documents including the clinical evaluation report (CER)
★★★★★ "I learned a lot from this webinar, it was obvious that the speakers (Barbara and Mary-Ann) are not o... more"
4-5 July 2023
+ 23-24 November 2023
from £1099
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.
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.
Gerry McGregor received his PhD in at Imperial College London, before taking up a post-doctoral position at the Max Planck Institute of experimental medicine in Göttingen, Germany. During several years in medical research at Marburg University, Germany, Gerry published extensively in scientific journals. In 2000, he joined the pharma industry, where he began medical regulatory writing. In 2008, he joined a small CRO in Geneva as Head of Medical Writing and, from 2017 until end of 2020, was a Principal Medical Writer at Trilogy Writing & Consulting. Since beginning of 2021, he has been working as a Freelance Medical Writer. During the last 10 years, he has written and compiled several CERs for medical devices, and is based in Germany.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
4-5 July 2023
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12253
Not ready to book yet?
for 7 days, no obligation
23-24 November 2023
Live online
09:30-16:45 UK (London) (UTC+00)
10:30-17:45 Paris (UTC+01)
04:30-11:45 New York (UTC-05)
Course code 12386
Until 19 Oct
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
I learned a lot from this webinar, it was obvious that the speakers (Barbara and Mary-Ann) are not only experts in their domains but also passionate about them.
Mar 15 2023
Andrea Parada
Medical Writer, Withings Inc
Mar 15 2023
Barbara Grossman did a wonderful job with her interactive presentations.
Netty Dorrestijn
Clinical Evaluation Officer, Dutch Ophthalmic Research Center
Mar 15 2023
The presenters were great, as were the participants. Very good (funny) examples in the technical writing sections :) Overall very good
Terry Alverson
Sr Director RA/CA, Haemonetics, Inc
Oct 19 2022
Both Janette and Barbara have been great! The course content was very interesting and informative... I really liked how interactive it was - the speakers used polls and several open questions to make the conversation flowing. The workshop was also a great way of exchanging ideas with other participants and put in practice what we had just learnt
Monica Masini
Clinical Expert, GE Healthcare
Oct 19 2022
It was a good summary of all topics.
Melisa Aslan
Clinical Affairs Specialist, KLS Martin L.P
Oct 19 2022
The speakers were really polite and professional
Aliki Kadi
Regulatory Affairs Specialist, Sinclair Pharma Ltd.
Oct 19 2022
Overall was really great.
Angelica Morreno
Regulatory Affairs Assistant, Sinclair Pharmaceuticals
Apr 6 2022
As a non native speaker I wanted to gain experience in writing medical devices study or evaluation reports. I learned alot in which mistakes to avoid and the language to use.
Elona Mulai
Associate Clinical Project Manager, Corcym Srl
Oct 19 2022
Great presentation and the speakers really were experts in the field. Interactive parts were nice (Polls and workshop) gives a better view of why certain topics are thought and keeps you active
Maarten van Veghel
Development Engineer, 3Dsystems
Oct 19 2022
Great presentation and the speakers really were experts in the field... Interactive parts were nice (Polls and workshop) gives a better view of why certain topics are thought and keeps you active
Maarten van Veghel
Development Engineer, 3Dsystems
Oct 19 2022
It was a good webinar, people were encouraged to engage. The presentations were clear and the speakers were good!
Dewi Golsteijn
Laboratory manager, PanPath B.V.
Apr 6 2022
As a non native speaker I wanted to gain experience in writing medical devices study or evaluation reports. I learned alot in which mistakes to avoid and the language to use.
Elona Mulai
Associate Clinical Project Manager, Corcym Srl
Mar 3 2021
The content was really good. A lot was covered. Very experienced presenters, and very knowledgeable.
Isabelle SABOUNTCHI
Senior Consultant, Medical Devices, Beyond Conception GmbH
Mar 3 2021
It is very difficult to make training engaging when performing it remotely but I felt this webinar was really successful from the assistance from Management Forum, to the course content and the interesting speakers. The attendees were really good too as they made the most of the opportunities to participate and ask questions. Overall, I really enjoyed it. Thank you.
Jennine Walker
Clinical Affairs Manager, Dermal Laboratories Ltd
Mar 3 2021
I really enjoyed it! The webinar was well structured, the contents well chosen and Barbara and Janette managed to bring ("teach") their respective contents to us in a simple and effective manner.
Lena Jung
Clinical Affairs Manager, Richard Wolf GmbH
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2 days
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: