Course Description

This series includes a review of the Clinical/Performance Evaluation Reports (CER/PER) requirements in the EU MDR and IVDR (EU Reg 2017/745 and 746, respectively) and associated guidelines along with a discussion of the CER/PER regulations outside the US. All devices are required to have a CER/PER for products marketed in the EU and globally. Good writing skills and techniques needed to create a CER/PER and to respond to reviewer comments will be explored. This highly interactive program will be based on the included course textbook, and learners will have the opportunity to share their experiences and ask specific questions about CERs and PERs.

Textbook Included! Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) A Practical Guide for the European Union and Other Countries

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Describe the history of CER/PER development
• Summarize the Clinical/Performance Evaluation Reports (CER) requirements in the EU MDR (EU Reg 2017/745 and 746) and associated guidelines
• Create a work plan for CER/PER development
• Summarize key CER/PER features evaluated by Notified Bodies
• Use CEP/PEP template (provided) to complete a CEP/PEP
• Use CER/PER template (provided) to complete a CER/PER
• Use PMCFP/PMPFP template (provided) to complete a PMCFP/PMPFP
• Engage and respond to a critique from an experienced CER/PER reviewer

Course Outline

• Module 1: Introduction and CER/PER Requirements
• Module 2: Planning Clinical/Performance Evaluations
• Module 3: Identifying Clinical/Performance Data
• Module 4: Appraising Clinical/Performance Data
• Module 5: Analyzing Clinical/Performance Data
• Module 6: Establishing Clinical Benefit-Risk Ratios
• Module 7: Writing Clinical/Performance Evaluation Documents
• Module 8: Writing SSCPs/SSPs
• Module 9: Reviewing CE/PE Documents
• Module 10: Integrating CE/PE, PMS and RM Systems
• Module 11: Understanding CER/PER Regulations Outside of Europe
• Module 12: Forecasting CER/PER Future Directions

Available by individual module! Contact Barnett to learn more.

Who Should Attend

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

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S, F.R.A.C.P

Click here for complete trainer biographies

Course Length and Time

1.5 hours/week for 12 weeks.

Registration Fees

$1,795 by Early Bird Deadline 

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 18 hours (1.8 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-064-L99-P. Released: 9/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.