Ensuring a Timely & Efficient Approach to Final Steps in Transitioning to MDR Compliant Clinical Strategies Including a Strong Focus on PMCF Requirements, all while Establishing Defined Study End-Points to Optimize Trial Design, Budgeting & Generation of Relevant Quality & Volume of Data
With the ongoing transition to the Medical Device Regulation, clinical affairs professionals continue to face unprecedented challenges in updating strategies to ensure compliant design and conduct of trials in the European Union. Finalizing the development of a comprehensive clinical evaluation plan encompassing all new requirements remains at the forefront of the industry’s attention, with a particular focus on continuing to clarify authorities’ requirements regarding sufficient levels of clinical data, as well as the type and volume of data sets considered relevant to fulfill expectations. To reach desired data generation goals, the clinical study end-point must be precisely defined, also allowing for sound establishment of patient recruitment numbers, trial duration and optimized SOP. While pre-market studies for new products remain critical to device companies, much focus is set on PMCF requirements and the need to proactively implement a data collection strategy to enhance market performance monitoring and early address of adverse events, with the complexity of identifying applicable data to report to authorities.
The 11th edition of the EU Medical Device Clinical Research Conference will once more dive deep into pressing challenges for clinical teams, both from the regulatory and operational stand-points, delivering unparalleled insight into practical industry case studies alongside authority and notified body clarification of expectations. Pushing the learning opportunity further, the conference will enable participants to gain knowledge through a diversified approach to formats, moving beyond traditional presentations only and into peer-to-peer experience sharing as well as practical workshops. With timely topics of importance also including strategizing for GDPR compliance, budgeting studies under the MDR, and maximizing the use of registries, the event will not only ensure content of the utmost importance is delivered but also offer a vast networking platform through dedicated sessions for a maximized on-site experience.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
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