🇨🇿 Manufacturer’s Post-marketing Activities II – Clinical Follow-up (PMCF)
The second in a series of three webinars that will take you through key aspects of post-market monitoring of medical devices, including post-market clinical follow-up and the vigilance system. This seminar focusing on PMCF of medical devices is primarily aimed at manufacturers.


Date
12 Sept 2024, 09:30 – 11:30
Online: Cisco Webex
About
The event is held in Czech language only!
The webinar is designed for anyone involved in device manufacturing regulation, whether as a regulatory compliance officer (PRRC), quality manager, quality management system (QMS) manager, clinical trial manager or post-manufacturing surveillance (PMS). Want to improve or even implement a medical device PMCF but not sure how to properly handle this responsibility? We will present you the basic requirements and tips for the planning, execution and reporting of a PMCF according to Regulation (EU) 2017/745 (MDR) in an easy-to-understand way.
Lecturers:
Lýdie Hojková
Magdalena Folkmanová
Content:
PMCF objectives
introduction of PMCF data sources
PMCF as a source of clinical data for updating clinical trials
PMCF plan and report content requirements using MDCG 2020-7 and MDCG 2020-8
Tips for designing a PMCF questionnaire (what to monitor; on which and how large a user population)
PMCF trial - brief overview of requirements and approval process
Related webinars:
5 Sep 2024 – Manufacturer's Post-marketing Activities I – Post-marketing Surveillance (PMS)
19 Sep 2024 – Manufacturer's Post-marketing Activities III – Vigilance
Additional information:
During the webinar, participants will have the opportunity to ask questions
each participant will receive a certificate of attendance
a PDF of the presentation will be sent to all participants
Participation fee:
3.900 CZK excluding VAT
8.900 CZK excluding VAT when ordering all three webinars to watch after the launch
100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant