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
- Changes made to the MDCG guidance document for PRRC
- The role of the PRRC to oversee, guide and not necessarily do
- The role of the PRRC in ensuring horizontal regulations/directives are in scope
- Nancy Consterdine - Director of Training and Compliance Services, IVDeology
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
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?
- Heike Möhlig-Zuttermeister - Global Director in-vitro Diagnostics (IVD), TÜV SÜD
- Stefan Burde - Director Global Strategic Business Development IVD, TÜV SÜD
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?
- Roshni Kasturi - Clinical Lead, MDR/IVDR, a leading diabetes care provider
- Reviewing the final rule
- When does the new rule apply and what are the transition periods?
- Impact on industry
- Difference between if a company is already 13485 compliant or not
- How will the FDA inspect in the interim?
- Future of harmonisation
- Is this the start of further global harmonisation?
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina
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
- Dun Liang - Executive Director, Diagnostics Regulatory Strategy, Loxo@Lilly
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
- Andrew L’Huillier - Director Regulatory Affairs Liaison – Diagnostics, Merck