15th & 16th April 2020, Amsterdam
Many industry regulators and clinicians are gearing up to European Union In Vitro Diagnostics Regulation (EU IVDR) transition and prepare as best they can to meet the explicitly stated expectations for performance evaluation. The EU IVDR has become more stringent and has tightened requirements by introducing new terms, definitions and processes for pre-market phase and post-market phase performance evaluations. TT Group Worldwide introduces this unique platform to educate and train executives working within the diagnostic departments to commercialize new diagnostic tests through CE Marking and the execution of performance evaluations to support CE Mark, i.e. Clinical Affairs, Clinical Science, Clinical Research, Quality Assurance and Regulatory Affairs.
The 2nd Annual European IVD Performance Evaluation & Regulatory Conference will focus on detailed and educative sessions by distinguished industry leaders on the challenges faced in the process of obtaining clinical evidence, developing regulatory compliant performance evaluation programmes, collecting data for scientific validity and the analytical & clinical performance, assessing and reporting the data to demonstrate the sufficiency of the clinical evidence to support the manufacturer’s intended use for the device, technical requirements and methodologies for effective evaluations, practical guidance and case studies. Through highlighting the specific regulatory and performance evaluation challenges of the diagnostic market in Europe, this conference is certainly a must-attend for the 2020 event calendar
For more information about the conference speakers, please click here