🇨🇿 Manufacturer’s Post-marketing Activities II – Clinical Follow-up (PMCF)

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