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ONLINE TRAINING: How to write a Clinical Evaluation Report from MDR Perspective
The clinical evaluation report (CER) is an important part of the Technical File/ Design Dossier for a medical device. The medical writer conducts the literature review and compiles the CER with input from design engineers, regulatory specialists, safety scientists and quality experts. The aim of this online training series is to better understand what is involved in writing a CER to Medical Device Regulation (MDR) 2017/745 standards. The online training will focus on the increased requirements of MDR and will cover the clinical evaluation process, literature review and post-market surveillance (PMS) and benefit-risk assessment.
The online training will be divided into 3 x 2-hour modules spread over 1 week
MODULE 1: Clinical Evaluation Process
- Introduction and webinar overview
- Medical device directives, guidelines and regulations
- ISO 14155-3 guideline
- MEDDEV 2.7/1 rev. 4 (2016) guideline
- Medical Device Regulation (MDR) 2017/745
- Medical Device Classification
- Clinical Evaluation Plan
- Clinical Evaluation Process
- Clinical Evaluation Report
MODULE 2: Literature Review Part of CER
- Literature Review Protocol
- Literature Searches
- Current Knowledge / State of the Art
- Clinical Literature
- Literature Appraisal
- Data Extraction
- Cliniical Literature Analysis
MODULE 3: PMS and Benefit-Risk Part of CER
- PMS Activities: MDR and MEDDEV 2.12/1 rev.8
- Periodic Safety Update Reports
- Post-market clinical follow-up: MDR and MEDDEV 2.12/2 rev. 2
- Risk Assessment
- Benefit-Risk Assessment
The course will be in English
Gillian is a pharmaceutical physician and regulatory medical writer with over 30 years’ clinical and industry experience providing regulatory writing services for 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, 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.
The online training will be of interest to anyone involved with the clinical evaluation process and who contributes to the CER:
- Clinical Department managers
- Regulatory Affairs managers
- Marketing staff
Experience of writing or contributing to a CER and awareness of the MDR 2017/745 would be useful.
The online training format will be a slide presentation with the opportunity to ask questions and respond to audience polls during the session.
Online training - 3 modules
June 25th, 2020 2:30 – 4:30 pm CEST
June 29th, 2020 2:30 – 4:30 pm CEST
July 1st, 2020 2:30 – 4:30 pm CEST
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: € 610,00* (until 4 June 2020)
Ordinary: € 685,00*
Freelance - Academy - Public Administration**: € 366,00*
* 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.
Thursday, June 4, 2020
At the end of the training, you will be able to
Have a better understanding of how to write an MDR-compliant CER