One-Day Virtual Seminar Statistical Elements of Post Market Clinical Follow-up (PMCF)

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The EU MDR 2017/745 includes new standards for CE marking of devices in the EU, one of the new standards is for the development and execution of a Post Marketing Clinical Follow-up plan. (PMCF).

PMCF is a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer’s post-market surveillance plan. When conducting PMCF, the manufacturer should proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

PMCF shall be performed pursuant to a documented method laid down in a PMCF plan. The focus of this seminar is to provide the statistical understanding and information needed to design and report a post-market clinical follow-up (PMCF) study. Making use of The MDCG 2020-1 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies (April 2020), participants will learn how to develop a PMCF plan and conduct data collection and interpretation for the PCMF clinical evaluation report.

Who Will Benefit:

  • Investigators
  • Physicians
  • Clinical Investigators
  • Clinical Research Statisticians
  • Clinical Research Coordinators
  • Clinical Research Associates/Assistants
  • Clinical Project Managers/Leaders
  • Study Managers
  • Data scientists
  • Data managers
  • Data processors
  • Statisticians

Regulatory Professionals who use statistical concepts/terminology in reporting
Professionals in pharmaceutical, medical device, clinical and biotechnology research who work with data collection and management
Medical Writers and others who need to interpret statistical reports

December 2nd, 2020 (10:00 AM - 4:00 PM PST)

  • Overview and Information on PMCF Regulations and Requirements
    • EU MDR 2017/745 on medical devices from 5 April 2017
    • EN ISO13485: 2012 clauses 8.2.1 and 8.5.1
    • MEDDEV 2.12/1 Rev. 8, Medical devices vigilance systems
    • MEDDEV 2.7/1 Rev. 4, Clinical evaluations
    • MEDDEV 2.12/2 Rev. 2, Guidelines on Post Market Clinical follow up (PMCF)
    • PMS Sources NBMED 2.12 rec 1
  • The many ways of statistical interpretation
    • p-values
    • Confidence intervals
    • Effect sizes
    • Clinical vs. meaningful significance
  • Common Statistical Tests:
    • Comparative tests (t-tests, ANOVA)
    • Tests of Association (Chi-Square test of Independents, Correlation, Multiple Regression
    • Systematic Reviews and Meta-Analysis
  • 30-minute break
  • PCMF Plan

    According to MEDDEV 2.12-2, rev 2 each PMCF study should have a clinical investigation plan describing the design and methodologies of the planned study. The areas covered in this section will include:

    • Power analysis for sample size
    • Surveys in the PMCF Framework: 10 Tips for development and use.
    • PMCF Study Overview: Needs, Reasons, and Discussion of a Plan
Seminar (Price/Register)
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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