keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
Day Three – 12 June 2024 - CEST (Cent Europe Summer, GMT+2)
keyboard_arrow_leftSearch & Filter
search
Streams
Clear
Day Three – 12 June 2024 - CEST (Cent Europe Summer, GMT+2)
search
Streams
Clear
Showing 1 of 1 Streams
In Vitro Diagnostic Regulations
09:00 - 09:10
Chairperson’s Opening Remarks: In Vitro Diagnostic Regulations
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
09:10 - 09:55
Class D The Latest News: Conformity Assessments and Common Specifications
- Conformity assessments for Class D
- Current requirements from Notified Bodies
- Challenges for manufacturers
- A focus on current common specifications
- What changed within the new version?
- How much effect does this change have on industry?
- How are notified bodies ensuring compliance to these specifications?
- Tommy McDonagh - Associate Director Regulatory Affairs (IVDR), Abbott Core Diagnostics
09:55 - 10:40
Deep Dive: European Reference Labs (EURLs), Notified Bodies and You
- Feedback on the status of EU reference laboratories.
- How many EURLs are currently designated, what do they cover?
- How do notified bodies work with EURLs?
- Impact on notified bodies and manufacturers after EURL designation, taking into account IVDR transition periods.
- Possible process for IVD approval with EURL involvement based on IVDR requirements.
- What if there is no EURL for an class D testing scope yet?
- How do notified bodies work without EURLs?
- Heiner Scheiblauer - Head IVD Testing Laboratory, Paul-Ehrlich-Institut
Showing 1 of 1 Streams
In Vitro Diagnostic Regulations
11:10 - 11:40
Rollout of EU Reference Laboratories for IVDR; What to Expect
- Where are the notified bodies and EU Reference Laboratories with the implementation of EU 2023/2713?
- What are the potential scenarios for conformity assessment of legacy Class D devices before and after October 1, 2024.
- What can manufacturers do to prepare for the implementation of the EURLs oversight process.
- Alex Laan - Head of IVD Notified Body, BSI
11:40 - 12:10
EU Green Deal
- EU Chemicals regulation updates – (REACH (One Substance One Assessment (OSOA), Essential Use), CLP, RoHS, Safe and Sustainable Chemicals.
- EU Circular Economy – Batteries, ECO Design and Sustainability for Products Regulation, Packaging and Packaging Waste Regulation, Packaging Labelling Directive, Waste Framework, WEEE and Extended Producer Responsibilities, Right to Repair, Critical Raw Materials
- EU Reporting – CSRD, Modern Slavery, Conflict Minerals, Supply chain Due Diligence
- Neil Plumridge - Regulatory Affairs, Quality Assurance and wider In Vitro Diagnostic, BIVDA
12:10 - 12:40
The Impact of IVDR for Health Institutions
What is the practical impact of IVDR for health institutions, both when new CE-IVD kits come onto the market and when CE-IVD kits are (temporarily) taken off the market? Where can health institutions collaborate with industry to increase patient safety?
- Elizabeth Dequeker - Head of the Biomedical Quality Assurance Research Unit, University of Leuven
Showing 1 of 1 Streams
In Vitro Diagnostic Regulations
14:10 - 14:15
Chairperson’s Afternoon Remarks: In Vitro Diagnostic Regulations
- Jai Pandey - Global Device Regulatory Head for In-Vitro Diagnostics and Digital Health, Sanofi
14:15 - 14:45
Cross-Industry Learning: The Impact of IVDR on the Pharmaceutical Industry
- Potential Shortages of Commercially Available tests and an expected reduction in labs able to use IH-IVDs (LDTs for routine testing purposes with Precision Medicines
- Potential delays in clinical trials of Precision Medicines using IVDs with a medical purpose.
- Patrick Fivey - Director of Precision Medicine Policy, AstraZeneca
14:45 - 15:15
Clinical Trials & Pharma: Assessing the Impact of the IVDR
- What is the impact of IVDR on the ability to enroll patients into trials?
- How is IVDR impacting trials that have patient selection and further what is the impact to inclusion/exclusion and assays/data used for medical management?
- How is country by country variability impacting trials and how divergent are the various opinions?
- What is the expected impact of the US LDT regulations and what is different/the same to IVDR?
- What infrastructure is needed to support these changes for drug developers, sites and laboratories?
- Have laboratories managed to meet the requirements of IVDR and what are the current gaps?
- What infrastructure does the industry need to build for a better future state?
- Kristina McGuire - Executive Director and Head, Precision Medicine Laboratory Operations and Companion Diagnostics, Regeneron
15:15 - 15:45
IVDR Certification Maintenance - First Recertifications are Approaching
- First IVDR Certificates have been issued end of 2020 – First Recertification is ahead!
- Impact of transitional provisions on legacy devices – MDCG 2022-8 provides some clarity.
- Which Surveillance requirements need to be fulfilled for specific IVDs?
- PSUR versus PMS Report
- SSP – PMPF -Continuous update of PER
- Regular IVDR QMS Audits
- Which data, which time intervals are expected?
- Heike Möhlig-Zuttermeister - Director Expertise Management & Segment Manager IVD, TÜV SÜD
Showing 1 of 1 Streams
In Vitro Diagnostic Regulations
16:15 - 16:45
Adhering to PMS Vigilance Requirements: EU vs UK
- Current requirements for adverse events, FSCAs and trend reporting
- Similarities and differences across regions
- UK Case study: filing an adverse event on new MORE Web Portal
- Differences between UK & Northern Ireland
- Laurent Oliviero - Complaint Handling Specialist 4, QuidelOrtho
16:45 - 17:45
IVDR Open Forum: Ask the Experts
Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!
- Patrick Fivey - Director of Precision Medicine Policy, AstraZeneca
- Heike Möhlig-Zuttermeister - Director Expertise Management & Segment Manager IVD, TÜV SÜD
- Rolf Thermann - Section Manager IVD and Companion Diagnostics Lead, TUV Rhineland
- Lakshman Ramamurthy, PhD - Vice President, Regulatory Affairs, GRAIL
- Stuart Angell - Chair of Regulatory Affairs Working Party & Member of the Executive Board, BIVDA
- Marta Carnielli - Head of Certification IVD, TÜV SÜD Product Service GmbH
Get the Latest Event Updates
Sign up to get the latest event updates and information.
Filter
Streams
Clear