CER Essentials Course
What's included in the GLOBAL CER Essentials Course?
The Introduction to CER writing training is a 10-hour interactive course that focuses on the practical aspects of CER writing. Over a period of 5 days, the instructor will take you through the steps of the clinical evaluation, bridging the gap between regulatory requirements and their practical implementation, including tips and tricks for effective writing.
Day 1
The first day of training centers on covering the basics of the MDR and some of the key takeaways for writing CERs. The training then moves on to CER scoping and writing a clinical evaluation plan (CEP). Our day will conclude with a discussion on establishing state of the art. Time will be reserved for questions and discussion.
Day 2
The second day will continue the state of the art discussion, with a closer look at collecting and evaluating benchmark device data. This discussion will serve as the foundation for the subsequent topic, identifying and establishing safety and performance outcomes and acceptance thresholds. Time will be reserved for questions and discussion.
Day 3
Day 3 builds on the safety and performance metrics discussion as learners apply their knowledge to extracting data from clinical literature. Learners explore literature search strategies, data collection and extraction, and summarizing key clinical data. Time will be reserved for questions and discussion.
Day 4
The penultimate session focuses on other sources of clinical data, including vigilance data and clinical and non-clinical data held by the manufacturer. Time will be reserved for questions and discussion.
Day 5
The final day of training will cover analysis of clinical data and conclusions of the CER. A discussion on post-market surveillance and post-market clinical follow-up will follow. Time will be reserved for questions and discussion.
Who should attend the training?
The CER Essentials Course training is open to everyone! Whether you're an established freelance writer looking to expand your skills, a recent graduate looking for additional knowledge, or an experienced regulatory writer looking to familiarize yourself with CER writing, CER Essentials training can be for you!
Who delivers CER training?
GLOBAL’s CER training programs are highly effective because they are taught by experienced writers, managers, and consultants in this field. These individuals keep a finger on the pulse for updates to regulations and guidance documents, and know many best practices that can help your internal teams. The CER training program is updated regularly to reflect the latest knowledge in this field. Our team has authored hundreds of MDD (MEDDEV 2.7/1 Rev 4) and MDR CERs for dozens of manufacturers. We have worked with many of the major Notified Bodies on devices ranging from simple Class I devices to invasive Class III implantable devices. When it comes to best practices and solid strategies, we’ve got you covered.
What happens after training?
The training will be delivered virtually. Attendance to all sessions is required for course completion. Graduates will have access to the recorded training for 3 months and will receive a certificate of completion.
