The ‘How to Guide’ to Clinical and Regulatory performance study success under IVDR

On Wednesday 24th April at 14:00 (GMT +1) ARC Regulatory and Pharmaxi LLC hosted a joint webinar discussing our latest 'How to Guide' to Regulatory and Clinical performance study success under IVDR. 

Hosted by Lauren Fullerton (Senior Marketing Manager) for ARC Regulatory, this webinar involved two presentations and an interactive Q&A session lasting approx. 1hr.

To begin the webinar, we had our SME Uma S (Senior Specialist - Regulatory Affairs) from ARC Regulatory who discussed the following:

💡How should a company begin to transition to EU IVDR compliance?
💡Identifying compliance gaps for EU IVDR 2017/746
💡Importance of Economic Operators Agreements Review, including your European Authorized Representative (EC REP) agreement.

Followed by Yurii Lebid (CEO of Pharmaxi LLC) who discussed:

🌍 Mastering the Timeline: Unlocking the Secrets to Efficient Clinical Performance Studies: Dive into the art of timing for clinical performance studies. Discover the factors influencing your timeline, and learn strategies for minimizing the duration without compromising quality. Find out the shortest possible timeframe to conduct a robust study and what it depends on.
 
🌍 The Launchpad for Success: Essential Steps to Initiate Your Clinical Performance Study: Begin your journey with confidence. This segment will guide you through the crucial preparatory steps required to kick-start a clinical performance study. From regulatory compliance to stakeholder engagement, learn everything you need to set the stage for success.
 
🌍 Ensuring Excellence: Key Strategies for Maintaining Control and Achieving Reliable Results in Clinical Performance Studies: Discover the pivotal aspects of clinical performance studies that demand your attention to guarantee credible outcomes. Explore advanced strategies for managing variables, ensuring quality data, and navigating the complexities of study design for unassailable results.

To watch this webinar, please complete the form below to gain access: