Speaker Jérôme Randall, PhD Scientific Affairs Manager Date March 11th & 13th 2025, Online Duration 6 hours | 2 x 9:00 – 12:00 AM US Eastern Standard Time, 2 x 3:00 – 6:00 PM Central Europe Time Virtual A recording will be available to registered participants, in...
Training: EU General Data Protection Regulation (EU GDPR)
Speaker Elena Lucano, PhD, Senior Manager, Quality and Regulatory Affairs Date March 20th 2025, Online Duration 4 hours | 8:00 – 12:00 AM US Eastern Standard Time, 2:00 - 6:00 PM Central Europe Time Virtual A recording will be available to registered participants,...
Training: Basic Biocompatibility Practical Perspective & Regulatory Aspects
Speakers Monica Grekula & Lina Burman Date April 8th & 11th 2025, Online Duration 6 hours | 2 x 8:00 – 11:00 AM US Eastern Daylight Time, 2x 2:00 – 5:00 PM Central Europe Summer Time Virtual A recording will be available to registered participants, in case...
Case Study: Determining Daily Fertility Through an App that Tracks Basal Body Temperatures and Period Data
Does Size Matter? Rescue from a large CRO
THE CHALLENGE Missed timelines and EDC build errors compromised the potential success of the company’s phase 1 study.THE SOLUTION Experienced team members and robust internal reviews resulted in a timely, high-quality EDC build and data management plan.THE OUTCOME...
Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important deadlines, exceptions and the main differences in the way these tests will be overseen on these two continents.Please...
Webinar – 2024 IVDR Sprint Series: How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines
2024 IVDR Sprint How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines The In-Vitro Diagnostic (IVD) industry plays a pivotal role in modern healthcare by providing crucial information for patient management. In Europe, the...
Webinar: Panel Discussion – FDA’s Regulation on LDTs: Current Impact and Future
In this recorded panel discussion, members of different healthcare organizations discuss the potential impact of the FDA Rule on LDTs, near term / long term implications, and stakeholder’s priorities for minimal disruption. By watching this panel discussion, you will:...
Webinar – 2024 IVDR Sprint Series: Companion Diagnostics (CDx) – Critical Areas and Implications for Successful Development and Launch in the EU
In this recorded webinar, Amit Kumar Jain and Veronique Treil from Veranex share some of our first-hand industry expertise, helping you stay attuned to the latest industry developments, challenges and advancements specifically related to Companion Diagnostics and...
Webinar – 2024 IVDR Sprint Series: Usability and Human Factors: Cornerstones of Near Patient Testing – Insights and Perspectives from a Notified Body
Near-patient testing (NPT) devices face substantial challenges under the new IVDR, including: New Stringent Regulatory Constraints due to IVDR Risk-Based Approach for Usability and Human Factors, including Use Environment Expectations from Notified Bodies In this...