Day Three – November 7, 2024
Day Three – November 7, 2024
How have recent innovation changes affected IVD innovation and innovative diagnostics coming to market?
Impact of new LDT rule, IVDR and beyond
Current state of play for innovation across regions
Innovative pathways across US, EU and APAC
Perceived level of innovative devices in circulation
- The future
How can we encourage innovative diagnostics back to market?
- Stefan Burde - Director Global Strategic Business Development IVD, TÜV SÜD
- Lindsay Darling - Director, Companion Diagnostics Portfolio Management & Operations, Regeneron
- Colleen Adams - Senior Director, Regulatory Science, Qiagen
- Dun Liang - Executive Director, Diagnostics Regulatory Strategy, Loxo@Lilly
- Lakshman Ramamurthy, PhD - Vice President, Regulatory Affairs, GRAIL
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
Current status of GUDID and EUDAMED databases
EUDAMED
Modules available and current status of those yet to be released
Applicability to US manufacturers
Comparison to GUDID system
- Case study: consolidating UDI for diagnostics
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
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
Which changes or repairs would signal a significant change?
Planning for repairs and maintenance
Key data points to consider
How can you plan for a repair or change without signalling a significant change?
Is repair and maintenance always commercially viable?
- Colleen Watson - Senior Director Regulatory Affairs, Thermo Fisher Scientific
What is considered sufficient data for IVDs?
How does this vary by diagnostic class?
Can you leverage US collected data for EU submissions, and vice versa?
Multi-stakeholder reflections: collecting suitable data and completing performance evaluations
- Rea Castro - Director of Medical Affairs, QuidelOrtho
- H. Jane Li, PhD, MBA, RAC (US) - IVD Product Reviewer, GMED North America
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
- Mapping out required post-market activities in both US and the EU
- Vigilance/Reporting and Surveillance requirements
- Curating Post-Market Plans
- Involvement of Regulatory, post-market Quality, Complaint Handling, Patient Safety (PV), Technical Support, and other teams
- Best practices for ensuring continued post-market compliance
- Anupam Talapatra - Senior Director, Regulatory and Quality, Freenome
Got any questions left over from the previous 3 days? Get your burning questions answered by our experts!
- Azam Khorshidi - Technical File Reviewer IVD, DEKRA Product Testing & Certification
- Adhiraj Mamak - Senior Manager, Global Quality Strategy & Alliances, Illumina
- Sid Mathur - Regulatory Affairs Executive Director, Companion Diagnostics, Merck