About the Conference:

As medical device manufacturers navigate the changing industry landscape throughout the implementation of the European Medical Device Regulation, one of the most pressing requirements facing clinical research executives is the enhancement of post-market clinical follow-up, surveillance, and reporting strategies. Placing a major focus on real-world evidence, the MDR presents professionals in clinical research with numerous challenges as they seek to provide an accurate representation of each device’s performance and safety once on the market. While the volume and sources of data required by competent authorities and notified bodies to support each device’s continued market presence are in some cases still uncertain, leaders in the field recognize the urgency of developing and implementing compliant plans for the collection of relevant and sufficient data while working to contain costs.

Core Topics to be Addressed

• Defining the level of clinical evidence deemed sufficient under MDR
• Proactively aggregating a body of evidence to meet PMCF requirements
• Examination of various cost-effective data gathering methodologies
• Optimizing the cohesive reporting of PMCF, PMSF & clinical evaluation data
• Aligning internal teams during development & implementation PMCF plans

Program Highlights:

• Insight into practical solutions for optimizing PMCF plans
• Engaging workshops & small group discussions
• Focus on knowledge-share & participatory learning

Target Audience:

• Clinical Affairs
• Clinical Development
• Clinical Evaluation

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