Course Description

Elevate your regulatory expertise and gain a competitive edge in the medical device industry with our comprehensive course on Clinical and Performance Evaluation Reports for markets outside the US. This course examines Clinical/Performance Evaluation Reports (CER/PER) requirements for EU MDR and IVDR (EU Reg 2017/745 and 746, respectively) and associated guidelines. The course curriculum also includes a peek at CER/ PER regulations outside the US. International and EU markets mandate the requirement to have a CER/PER for all medical device products. This program focuses on helping learners master effective evaluation and writing skills with techniques provided to ensure good CER/PER development and a clear understanding of potential reviewer comments with strategies to address Notified Body deficiencies if any have been noted in the past. This course will include interactive sessions, encourage participant experience sharing and will address specific CER/PER inquiries.

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

• Analyze CER/PER development and evolution as the device matures
• Interpret EU MDR (EU Reg 2017/745 and 746) CER/PER requirements and associated guidelines
• Construct CER/PER development work plans
• Identify critical CER/PER elements for Notified Body evaluation
• Apply CEP/PEP template (provided) for plan completion
• Use CER/PER template (provided) for report completion
• Implement PMCFP/PMPFP template (provided) for plan completion
• Formulate responses to expert CER/PER reviewer critiques to learn more

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

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.