Name: How to write a Clinical Evaluation Report from the MDR Perspective
SKU: 6368
Availability: InStock

Introduzione

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 course is to better understand what is involved in writing a CER to Medical Device Regulation (MDR) 2017/745 standards. The course 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 course will be divided into 2 x 3-hour modules

MODULE 1: The Clinical Evaluation Report

Introduction and course overview
Medical device directives, guidelines and regulations
ISO 14155:2020 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
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

MODULE 2: Literature Review Part of CER

Literature Review Protocol
Literature Searches
Current Knowledge / State of the Art
Clinical Literature
Literature Appraisal
Data Extraction
Clinical Literature Analysis

The course 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
CROs

Attendees’ experience
Experience of writing or contributing to a CER and awareness of the MDR 2017/745 would be useful.

The course format will be a slide presentation with the opportunity to ask questions, respond to audience polls and participate in group exercises.

Docente/i

Info

Gillian Pritchard

Director, Sylexis Limited

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 has given workshops on literature reviews, transferable skills in pharmaceutical and medical device writing, drug safety and ICH-GCP.

Durata e Informazioni utili
Quote Iscrizione

Online training – 2 modules

April 12th, 2022 2:00 pm – 5:00 pm CEST
April 14th, 2022 2:00 pm – 5:00 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: € 660,00* (until 18 March 2022)

Ordinary: € 780,00*

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.