Writing Clinical Evaluation Reports

Course #: SBPA0518
May 15-16, 2018 | Philadelphia, PA
8:30 AM - 5:00 PM Eastern
Convene Commerce Square
*
$1,875.00

Course Description

This course will include a review of the Medical Devices (MEDDEV) 2.7.1, Rev 4 guideline issued in June 2016 and a discussion of the Therapeutic Goods Administration (TGA) guideline. In this interactive program, participants will also have the opportunity to share their experiences with Clinical Evaluation Reports (CERs) in general. 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.

Learning Objectives

  • Summarize the MEDDEV 2.7.1, Rev 4 guideline
  • Create a work plan for CER development
  • Summarize key CER features evaluated by Notified Bodies
  • Use CER template (provided) to complete a CER
  • Engage and respond to a critique from an experienced CER reviewer to complete CER

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

Instructor

The course will be led by one of the following instructors:

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

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Course Materials and Background  
  • Regulatory Requirements and Guidelines  
  • Evaluating Data and Telling the Story  
  • Literature Searching  
  • Appraising and Selecting Clinical Data - Inclusion/Exclusion Coding  

Day Two: 8:30 a.m. – 5:00 p.m. 

  • Analyzing Clinical Data
  • Writing CER – Technical Components  
  • Drawing Conclusions – Team/Medical Review  
  • Notified Body (NB) Review  
  • Conclusions  

Interactive Activities

  • SOP Template and Examples (Review, identify questions or concerns, report to group)
  • Current CER/SOP Review (Review, identify questions or concerns, report to group)
  • CER Checklist (Review, identify questions or concerns, report to group)
  • Notified Body Activities (Review, identify questions or concerns, report to group)
  • Literature Searches (Review databases, identify questions or concerns, report to group)

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.  

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-17-112-L01-P. Released: 9/17.

 

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