Considerations while Navigating Regulatory Pathways for Novel IVD Tests, Companion Diagnostics, & Precision Medicine, Addressing Clinical Trial Design & Validation of Technological Advancements, with Insights on Challenging International Regulations including EU IVDR & Asian Regulatory Pathways
December 12-13, 2019 | San Diego, CA | Andaz San Diego Hotel
Aligning Regulatory Data and Information through Enhanced Integration & Utilization of Regulatory Information Management Systems which Support the Highest Levels of Data Integrity and Seamlessly Support Global Regulatory Documentation from throughout the Product Lifecycle
January 14-15, 2020 | Arlington, VA
Ensuring Long-term Product Quality and Efficacy through Streamlined Postmarket Surveillance Processes including Integration of eQMS for Complaint Intake, Employment of Stringent Postmarket Cybersecurity Strategies and Proactively Preparing for EU MDR Compliance
January 22-23, 2020 | Alexandria, VA
Developing Robust Clinical Trial Protocols through Standardization of Data Driven Risk Assessment Models, Adequate CRO Oversight & Proper Documentation Practices to Match Regulatory Expectations & Ensure Quality by Design throughout the Clinical Trial Process
February 4-5, 2020 | San Diego, CA
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