12th Annual EU Medical Device Clinical Research ConferenceOctober 29-30, 2020 | Amsterdam, NL
Ongoing Clarification of Sufficient Clinical Data Pertaining to Specific Device Classes & Defining Relevant Study Design to Achieve Thorough Data Collection, Focus on ISO 14155 Revision & Integrating Updated GCP Measures, all while Establishing Robust Strategies to Address EUDAMED Delays
With the MDR transition period coming to an end, medical device manufacturers are organizing final steps for updated clinical strategies in light of the new rule. In particular, with the necessity for all products to fulfill the new clinical evaluation planning requirements, class I and up-classified developers are challenged with building evidence data sets from the ground up, while higher-risk products aim to understand more about expert panel reviews, as well as determining the most relevant study design and protocol to achieve desired data end goals. Furthermore, the revision of ISO 14155 and amended GCP adds to the complexity of establishing and executing robust clinical research in Europe, both in the pre and post-market settings. As an annual flagship program, the Q1 EU Medical Device Clinical Research Conference will once more dive into the practical intricacies of areas of timely concern, through peer-to-peer led exchange sessions alongside traditional presentation formats, bringing together a variety of speakers from the industry, regulatory bodies, ethics committees and hospitals alike for an optimized approach to each topic.