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
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
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
Elaine Eisenbeisz
Owner, Omega Statistics
Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.
Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.
Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.
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