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Good People Working on Good Projects with Good Process

Writing Clinical Evaluation Reports (CER) – Intermediate

September 26, 2019 (6 hrs) $975.00

 

Course Description

This Frestedt Learning Center course is a 6-hour session (8:30-2:30 CST) designed for Intermediate-level CER writers with 3-5 years’ experience and will include discussion of the MEDDEV 2.7/1 rev 4 guideline as well as the new MDR 2017/745 regulation. All devices are required to have a CER for products marketed in the EU and globally. This course will explore good writing skills and techniques needed to create a CER and to respond to reviewer comments. In this interactive program, participants will also have the opportunity to share their experiences with CERs in general and perform robust clinical data searches. The course is available in person at the Frestedt Inc. office (limited seating) as well as online (unlimited).

Benefits to Your Business

  1. Avoid frequent pitfalls of clinical regulatory submissions
  2. Provide robust documentation in support of the clinical safety and performance of your device
  3. Ensure continuing compliance throughout device lifecycle.

Learning Objectives

On completion of this training, participants will be able to:

  • Identify clinical data sources
  • Determine Equivalence
  • Select clinical trial, literature and experience data
  • Appraise and analyze clinical data
  • Write a CER

Intended Audience

  • Project ManagersClinical Data Specialists/ Analysts/Managers
  • Technical Communication Specialists/Medical Writers
  • Clinical Affairs DirectorsClinical Program Managers
  • Clinical Nurse Specialists
  • Post Market Surveillance Managers
  • CER/ Reporting Specialists
  • Evaluation and Research Directors
  • Clinical Education Specialists
  • Corporate Librarians
  • Regulatory Specialists/Managers

CER Writing custom training may also be tailored to individual business needs; duration and price will vary.

Agenda (CST)

8:00am-8:30am

Arrival and Check-in

8:30am-8:45am

Introduction

8:45am-10:30am

Hands-on identification of data

10:30am-10:45am

Mid-morning break

10:45am-12:00pm

Data Appraisal

12:00pm-12:30pm

Lunch

12:30pm-2:30pm

Data analysis and CER writing

2:30pm

Wrap-up and Q&A

Prerequisites

Three to five years of experience writing CERs, or beginner course completed

This course has completed. Check out our current courses!