Live Digital Training Course | Delivered in CET Time Zone
IVD School: Understand the Fundamentals of In Vitro Diagnostic Regulatory Affairs and Accelerate Time to Market
Dive into the Regulatory Requirements, Key Players in the Industry, How Your IVD Fits into the Bigger Picture, and How You Can Adapt Your Processes to Accelerate Your Path to Commercial Success
Course Overview
Develop your understanding of the very fundamentals of the in vitro diagnostic industry through this IVD School interactive training course. Navigate through the entire in vitro diagnostic lifecycle by immersing yourself in 3 days of sessions: from introductions to all stakeholders in the in vitro diagnostic ecosystem, regulatory pathways for diagnostic approval and post-market considerations. Additionally, benefit from engaging with eight specialised trainers, all of whom have extensive first-hand experiences with bringing in vitro diagnostic to market and adhering to the complex global regulatory landscape.
What Will You Learn?
Insights From 8 Trailblazers
Get the 101 on the in vitro diagnostic industry from eight industry thought-leaders over 3 full days
The IVD Ecosystem and the Key Players
Understand the in vitro diagnostic ecosystem and how all stakeholders interact to bring diagnostics to market
Navigating the New In Vitro Diagnostic Regulation (IVDR)
Understand the key requirements of the IVDR
Diagnostic Regulation Essentials
Learn the fundamentals of diagnostic regulations such as classification and conformity assessment
Risk Management
Examine the importance of having a robust risk management plan
Performance Evaluations for Diagnostics
Gain an insight into perfecting performance evaluations for diagnostics
Implementing a Quality Management System
Prepare for the Future — Understand the complexities associated with AI and curate strategies for successful incorporation
Post-Market Surveillance
Gain an insight into post market surveillance and vigilance to ensure your diagnostics continue to be safe on the market
Access to the UK and Swiss Markets
Examine the evolving requirements of the UK and Swiss markets and how to launch in vitro diagnostic products onto them
LIVE ONLINE TRAINING COURSE
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions two days prior to the course start date. If you have any questions please contact Melanie Epstein at melanie.epstein@informa.com