Clinical evaluation of a medical device is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. The clinical evaluation plan (CEP) describes how the clinical evaluation will be performed, including objective and measurable clinical benefits, acceptability parameters for the benefit/risk profile, determination of what will be considered ‘sufficient clinical data’, what data will be collected and how any knowledge gaps might be addressed. The CEP is regularly reviewed and updated and forms the basis of the clinical evaluation report (CER).
The aim of this course is to explore what is involved in developing the CEP, including initial literature reviews and instructions for use (IFU).
Gillian is a pharmaceutical physician and regulatory medical writer with over 30 years’ clinical and industry experience providing regulatory writing services to pharmaceutical and medical device clients. Gillian has broad pharmaceutical and medical devices experience across a wide range of therapeutic areas, e.g. cardiology, orthopaedics, clinical pharmacology, ophthalmology, diabetes and gynaecology. Over the years she has written numerous clinical study reports, clinical evaluation reports, literature reviews, clinical summaries and overviews, and various clinical trial documents. Gillian trained in medicine and was a research physician in academia and phase I-II contract research; a clinical project manager for phase III trials with Pfizer GRD; and also with a pharmaceutical and medical devices consultancy. She is a member of the Royal College of Physicians and Faculty of Pharmaceutical Medicine, has an MBA and an MSc in Clinical Pharmacology. Gillian is an active member of the European Medical Writers Association (EMWA) where she gives workshops on literature reviews, transferable skills in pharmaceutical and medical device writing, drug safety and ICH-GCP. She is a member of EMWA’s medical devices special interest group.
March 23rd, 2021 2:00 pm – 5:00 pm CET
March 25th, 2021 2:00 pm – 5:00 pm CET
After the registration, you will receive all details about the connection. The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird:€ 660,00*(until 23 February 2021)
Freelance – Academy – Public Administration**:€ 430,00*
*for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes:tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.