Is the In Vitro Diagnostic Regulation (IVDR) wearing you down? If so, you’re not alone.
No matter how you look at it, 2022 has been a tumultuous year for the in-vitro diagnostics industry leaving many industry stakeholders asking, “How did we get here?” and, “Where is all this headed?”
To be sure, 2022 has been a year of great regulatory change, but also one of significant learning and growth.
Huma.AI, a leading innovator in Regulatory Intelligence solutions, is pleased to host a new webinar, “IVDR 2022: The Year In Review,” featuring Carlos Galamba, VP of Intelligence and Innovation, RQM+, on Wednesday, December 14 at 11:00 am EDT. During the 45-minute webinar, Galamba will discuss some of the significant events, milestones, and top guidance documents of the past twelve months and what to expect in 2023 and beyond.
(Note: This live webinar will also be recorded and made available to all registrants.)
IVDR is a set of rules and guidelines that are used to regulate the production and use of medical devices and tests that are used to diagnose diseases and conditions in a laboratory setting.
Beginning with the approval of the IVDR transition in late 2021, and continuing up to an assessment of the current workload and suggested timelines for “getting it all done,” the webinar featuring Galamba will cover the following:
Plus, expect a look at the most recent news from Switzerland and the EU Commission, as well as what to anticipate in 2023.
IVDR is straining the industry by introducing new requirements and challenges that must be met to achieve compliance. This is proving costly and time-consuming, requiring significant changes to be made industry-wide.
Some of the most significant changes include:
In short, IVDR is causing significant changes in the IVD industry while creating new challenges and opportunities for manufacturers of IVD products.
Attend the webinar to get an insider's view on how IVDR's implementation has played out in 2022 and what to expect going forward.
Carlos Galamba is a veteran IVD insider and Vice President, Intelligence and Innovation with RQM+. Prior to joining RQM+, Galamba served as a technical reviewer, technical team manager, and clinician with BSI, a notified body. Before BSI, Galamba worked as a lead scientist with the National Health System in the UK, working in transfusion medicine.
Huma.AI is a leading provider of human-centric business intelligence for life sciences, including medical affairs, regulatory affairs, and clinical development software. A venture-backed AI startup based in Seattle, Huma.AI was co-founded in 2018 by CEO Lana Feng, Ph.D., and CTO Greg Kostello, to bridge the gap between scientific data and life science decision-making.