Day Two – November 6, 2024
Day Two – November 6, 2024
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
Classifying LDTs
Do all labs qualify?
The new legislation
Difference from previous legislation
Implementation timelines and transition periods
Impact on industry, notified bodies and regulators
- Colleen Watson - Senior Director Regulatory Affairs, Thermo Fisher Scientific
- Bill Kurani - SVP Regulatory Affairs, Clinical Affairs, and Quality Assurance, Antrix
- Stefan Burde - Director Global Strategic Business Development IVD, TÜV SÜD
- Anupam Talapatra - Senior Director, Regulatory and Quality, Freenome
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
With the new deadline extensions for IVDR in Europe, when do you need to be compliant by?
New deadlines by risk class
Qualifying for the extensions
Does everyone qualify?
What needs to be in place in order to qualify?
Implications for manufacturers in the US
- Azam Khorshidi - Technical File Reviewer IVD, DEKRA Product Testing & Certification
- Sid Mathur - Regulatory Affairs Executive Director, Companion Diagnostics, Merck
- Dun Liang - Executive Director, Diagnostics Regulatory Strategy, Loxo@Lilly
Introduction of the eSTAR system
How has this changed gaining diagnostic approval in the US?
Are eSTARs mandatory for all IVDs?
Impact of eSTAR implementation for industry
How has the form impacted working practice efficiency?
Common pitfalls and pain points with the form
How does it align to European submission processes?
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
Please contact: Linda Cole – linda.cole@informa.com
Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
Status of EURL designation
Which labs are certified EURLs
Are there more expected to come?
How does the designation of EURLs alter the certification process for high-risk diagnostics?
- Heiner Scheiblauer - Head IVD Testing Laboratory, Paul-Ehrlich-Institut
Overview of the impact of LDT, IVD and CDx regulatory landscape on pharmaceutical development
Anticipating the needs of your portfolio to ensure your diagnostic and laboratory toolkits are robust
Risks and mitigation tactics that can be applied to prepare for changes in regulations
- Lindsay Darling - Director, Companion Diagnostics Portfolio Management & Operations, Regeneron
- Sid Mathur - Regulatory Affairs Executive Director, Companion Diagnostics, Merck
- Dun Liang - Executive Director, Diagnostics Regulatory Strategy, Loxo@Lilly
- Lakshman Ramamurthy, PhD - Vice President, Regulatory Affairs, GRAIL