Day Three – 12 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
Day Three – 12 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
- Bassil Akra - CEO, AKRA TEAM GmbH
- Current regulations for clinical evaluations and investigations for devices
- Considerations for a successful clinical process, including evaluation and investigation
- European guidelines and harmonisation
- Focal points, ongoing work in the MDCG-CIE working group
- EUDAMED CI/PS module, update and the oversight board
- COMBINE, harmonization for European studies under IVDR, MDR, CTR
- Coordinated assessment procedure, Article 78 MDR
- Paul Piscoi - Scientific Policy Officer, European Commission
- Nebojsa Serafimovic - Assessor for Clinical Investigations, Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care
- Current regulations for performance evaluations under the IVDR
- Latest updates & on-going work
- Differences across regions
- Key documentation, data points and responsibilities for industry
- Khaudeja Bano - VP, Combination Product Quality, Amgen
- Eudamed Clinical Module: overview and status / transparency
- Clinical investigations and PMCF applications: key insights and harmonized approach?
- Diversity of clinical data collection?
- Which improvements from MDCG 2022-14 would be of values to the MDR transition?
- Carine Cochereau, Integra LifeSciences
Learning objectives will include:
Understand the importance / role of PMCF within the EU-MDR
Learn about the differing PMCF Survey approaches (Level 4 vs. Level 8)
Take away key learnings / considerations for how to plan a PMCF Survey
Level 4 PMCF Survey Case Study
Appreciate how PMCF surveys are implemented
- Marcus Torr - PMCF / MDR Lead, Purdie Pascoe
- Beau Rollins - Director, Quality Services, ConvaTec
The revised draft of the new Part 1 has brought about multiple changes so join us as we discuss its effects on the biological evaluation process.
- Jeannette van Loon - CEO, Medical Device Project B.V
• Overview of biological risk assessment per ISO 10993-1:2018
• What’s on the horizon for biological risk assessment per revisions that are currently under discussion
• Illustration of biological safety evaluation using a true risk assessment approach through a case study
- Crystal D'Silva - Senior Manager, Pre-Clinical Toxicology, Baxter
- Andreas Stange - Senior Vice President MHS Regulatory & Quality, TÜV SÜD Product Service GmbH
- 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
- Feedback on the status of the reference labs
- How are Notified Bodies working without them?
- How many are expected to be designated and by when?
- Impact on Notified Bodies and manufacturers once designated
- Working example: IVD approval with EURL involvement
- Alex Laan - Head of IVD Notified Body, BSI
- Jeff Shapiro - Partner, King & Spalding
- Kim Kaplan - Senior Product Manager, ISACA
- About FDA
- Medical devices, IVDs, drugs, combination products and CDx: FDA divisions and offices
- FDA Centre for Devices and Radiological Health (CDRH)
- Code of Federal Regulations (CFR)
- Standards and other guidance documents
Harmony & Discord
- A comparison of US and European Medical Device Regulatory Affairs
- Regulatory commonalities, overlaps and discprepancies
- Future trends
An introduction to routes to the US Market
- Classification
- Premarket Notification – (510(k)
- Introduction to Traditional, Abbreviated, Special, de novo & Exemptions
- Predicates & substantial equivalence
- Premarket approval (PMA)
- Modules, modular and full submissions
- Role of QMS (CFR Part 820)
- Quality Assurance
- Quality Control
- Classification: routes to market
- Comparison with EU/UK
- The 513(g) procedure
- What is Q-sub (still commonly known as a ‘pre-sub) and how does it benefit both the manufacturer and FDA
- How to prepare a ‘pre-sub’ document
- The ‘pre-sub’ meeting
- FDA feedback & follow up with the Agency
- Next steps
- Determining data sufficiency under the MDR & IVDR
- Are clinical or performance studies always necessary?
- When can you leverage previous data?
- Best practices for ensuring sufficient data
- Wojciech Bobela - Senior Regulatory Affairs Specialist, Novocure
- Ella Helgeman - Regulatory and Quality Director, Rehaler
- Nunung Nur Rahmah, M.D., Ph.D - Head of Internal Clinical Team, DEKRA
- Katarzyna (Kasia) Koscielska - Principal Scientist, Real World Data, Roche Diagnostics
- Overview of Direct vs. Indirect Clinical Benefits and the challenges
- Defining Safety and Performance Outcomes and Acceptance Criteria for Indirect Clinical Benefits
- Leveraging Safety and Performance Standards vs. Clinical Literature
- Adam Kleinman - Senior Medical Writer, Philips
- Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
- Golddy Kaur - President, MedTech Regulatory Strategist
- Kelly Coleman - Toxicologist, Medtronic
- Proper study design and thorough planning that considers device-specific intricacies in sample preparation is crucial for a successful biological evaluation. Improper sample preparation or extraction conditions can lead to additional evaluation time, testing costs, and animal use.
In this session, we will discuss some of the main contributing factors associated with:
Improper test article preparation.
Improper extraction conditions.
- Catherine Christensen - Principal Toxicologist, Medtronic
- With reference to MDCG 2022-14, is leveraging data a falsehood?
- When can data be leveraged or when is new data collection necessary?
- Which data could be leveraged?
- Could it be leveraged for devices of all classes?
- Case study: unsuccessful use of previous data and lessons learnt
- Tips for future leveraging attempts
- Heike Moehlig-Zuttermeister - Director Expertise Management & Segment Manager IVD, TÜV SÜD
- 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
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
- The 510(k) process, different types of 510(k) and De Novo submissions
- Predicate Devices
- Contents of a 510(k) submission
- Decision Summaries
- Post-market considerations including modifications to cleared devices (post-market requirements): keeping product on the US market
- The PMA process and different types of PMAs
- Contents of a PMA submission
- Summary of Safety and Effectiveness Data (SSED)
- PMA Annual Reporting
- Modifications to approved devices
- Bassil Akra - CEO, AKRA TEAM GmbH
- Under which regulations can RWE be used?
- Is RWE enough on it’s own or does a clinical trial always need to be carried out?
- Can it be used for both devices and diagnostics?
- Case studies: suitable RWE for differing risk classes
- Examples of collection, analysis and use in technical documentation
- Asha Jacob - Senior Manager Regulatory Affairs & Compliance, Philips
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
With the recent updates and newly revised ISO 10993-1, join us in discussion as we navigate the anticipated effects of these regulatory changes.
- Alina Martirosyan - Senior Scientific Manager Toxicology, B Braun
- Revieing New Approach Methodologies (NAM)
- Identifying the various types of sensitizers that leach from medical devices
- Data initiatives tox reports and literature
- Ron Brown - Toxicologist, Risk Science Consortium
Please contact: Roshni Shah roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- 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
- 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
- Jeff Shapiro - Partner, King & Spalding
- Kim Kaplan - Senior Product Manager, ISACA
- Notification [510(k)] vs Approval (PMA) output data requirements
- Preclinical data: design verification
- Clinical data: design validation
- The importance of project management: saving time and cost to market
- Design change: pre-planned and/or response to market feedback
- Imposing Quality throughout the product lifecycle to save time and cost
- Role in Product Development, Design Control and Design Review
- Input to Risk Management
- Importance for manufacturing
- Quality Control
- Audits and Inspections
- Forthcoming regulatory changes
- Determining what is and when to use research-initiated studies
- Influence of medical staff in initiating studies
- Benefits of such studies
- Best practices in fostering working relationships with hospitals
- Future impact
- How can utilising research-initiated studies benefit industry and the wider population?
- Sara Edvardsen - Research Scientist - Centre for Medical Devices, Technology and Innovation, St. Olavs hospital, Trondheim University Hospital
- Shelley Jambresic - Group Lead Science & Evaluation, Geistlich Pharma AG
- How diverse is clinical and performance data which is currently being collected?
- Is diversity covered in regulation?
- How much obligation is there for collecting diverse data?
- Availability and usability of diverse data
- Importance of enhancing diversity moving forward
- Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
- Maya Balamane - Senior Clinical Scientist, Intuitive
- Dissecting and explaining the requirements of MDR GSPR 10.4
Examples of hazardous substances
Determination whether hazardous substances are present above 0.1% w/w
To Do’s when hazardous substances are present above 0.1% w/w
- Christina Reufsteck - Biocompatibility Expert, TÜV SÜD
Meeting regulatory expectations in biocompatibility testing for medical devices
Biocompatibility challenges during MDR certification of legacy devices.
Addressing the “gap’ between regulatory expectations and industry practices
- Christina Reufsteck - Biocompatibility Expert, TÜV SÜD
- Jeannette van Loon - CEO, Medical Device Project B.V
- 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
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
- Production and process controls
- Inspection of measuring and test equipment
- Process validation