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Fast Facts
 

Highlights

Overview: This presentation takes a step-by-step approach to writing a Clinical Evidence Report (CER) including how to write up a review of: 

  • The clinical trial data
  • A well-designed literature review and
  • Marketing information showing appropriate post market surveillance
We will also discuss when the review and reports should be completed to aid your product development/stage gate or claim substantiation process, and how to create standard procedures in your clinical quality systems to outline the required steps. 

Why should you attend: You should attend if you have asked one of these questions: What is the value of a comprehensive and detailed literature review? Once all the articles are collected, how do you analyze the information in manageable pieces? How do you assess the quality of the information you have collected? How do you summarize the findings to ensure you have represented both the positives and negatives and then how do you incorporate this information into your clinical evidence report? 

Areas Covered in the Session:
  • How to conduct a comprehensive and detailed literature search
  • Methods to evaluation of the literature acquired
  • Development of a scientifically valid clinical evidence report
  • Incorporating the evidence into clinical evaluation reports
  • When it is most beneficial to conduct the review
  • How to include the process in your clinical quality systems
Who Will Benefit:
  • Directors of Clinical Affairs
  • VPs & Directors of Regulatory Affairs
  • Manager of Quality Systems
  • VPs, Vigilance and Safety Reporting
  • Clinical Research Coordinators & Associates
  • Document Administrators
  • Corporate Librarians 

Price List:Live : $245.00Corporate live : $995.00Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407Fax: 302-288-6884











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Event Profile

Sponsors: GlobalCompliancePanel
Speakers: Joy Frestedt
Attendees: Directors of Clinical Affairs,VPs & Directors of Regulatory Affairs,Manager of Quality Systems,VPs, Vigilance and Safety Reporting,Document Administrators,Corporate Librarians

Contact Details

Contact person: Webinars
Event website: http://bit.ly/ImWetX
Phone: 800-447-9407
Fax: 302-288-6884

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