What Diagnostics Developers Need to Know About Navigating the IVDR
Virtual Round Table - sponsored by Roche CustomBiotech - Available on demand
Since its rollout in 2017, the IVDR has remade Europe's oversight of in vitro diagnostics, placing new requirements on test developers selling into European markets. While portions of the regulation have yet to go into effect, it has already significantly impacted the diagnostics industry, creating new hurdles and procedures firms must navigate to bring their products to the clinic.
This on-demand event features four experts discussing what diagnostics developers need to know to successfully operate under the IVDR.
Panelists:
1. Caroline Alexander:
Director of QA/RA at Genedrive.
2. Sascha Wettmarshausen:
Head of regulatory affairs at VDGH.
3. Ilinica Visanoiu:
Regulatory affairs manager at MRC Holland.
4. Tracey Lomax:
Chief quality and regulatory officer at Global Access Diagnostics.
Stay tuned for the next virtual round table in October sponsored by Roche CustomBiotech:
LDT Regulation Post-FDA Final Rule: What’s Next for Labs and RUO Manufacturers?