10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)keyboard_arrow_right
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Day 1 - CET/CEST (Cent Europe Summer, GMT+2)
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Day 1 - CET/CEST (Cent Europe Summer, GMT+2)
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08:00 - 08:30
Conference Registration
Showing 3 of 3 Streams
European Medical Device Regulations
Medical Device Law and Compliance Track
Biological Evaluation Execution and Authorship Training
08:30 - 08:40Free
Chairperson’s Opening Remarks
- Eljar Amini-Nejad - Senior Consultant Medical Devices and IVDs, NSF
08:40 - 09:20Free
Industry Panel: Adhering to all European Requirements
- Industry's experience on implementing the different requirements from Europe
- Dealing with MDR, UK and Swiss updates
- Can you align processes to be appropriate for all markets?
- Common pain points
- Are there common trip hazards seen in each market?
- How to overcome these
- Lessons learned
- Key takeaways for certifying devices across Europe
- Eljar Amini-Nejad - Senior Consultant Medical Devices and IVDs, NSF
- Trine Østerby - Director, Regulatory Affairs ImmunoAssay, Radiometer
- Klien van Dam - Director, Quality and Regulatory Affairs EMEA, Avanos Medical
- Alice Forde - Director, Regulatory Affairs Europe - Medical Devices, Bausch & Lomb
- Natasha Bankowski - Director of Regulatory Affairs and Quality Assurance, Beyond Air
- Nadine Nasr - Senior Regulatory Affairs Manager, Intuitive Surgical
09:20 - 09:45Free
SwissMed Update: Latest Regulatory Updates for the Swiss Market
- Regulatory pathway for placing a device on the Swiss market
- Required documentation
- Designated Body expectations
- Bottlenecks
- Case study: successful submission to Swiss Market
- Daniel Delfosse - Executive Board Member, Director Regulatory Affairs, Swiss Medtech
09:45 - 10:15Free
UKCA: Where Are We Now?
- Latest regulatory update from the UK
- What is UKCA marking?
- How is this put on a product?
- UK Approved Bodies
- Identifying
- Working with
- Why the UK still an attractive medical device market
- Where does the UK sit within the global market?
- Steve Lee - Director, Diagnostics Regulation, Association of British HealthTech Industries (ABHI)
09:00 - 09:10Free
Chairperson’s Opening Remarks & Welcome to Conference
- Nathalie Smyth - Partner, Kennedys
09:10 - 09:40Free
Legal Perspective of the Changing Medical Device Landscape – Lessons learnt from EU MDR, application and areas of continued contention
- Legal review of the industry since the introduction of the MDR
- Lessons learned, challenges, common pain points
- Legal challenges and results
- Elvan Sevi Bozoglu - Partner, Bozoglu Izgi Attorney Partnership
09:40 - 10:10Free
Legal Considerations when using in vitro Diagnostics in Clinical Trials
- Legal perspective on the challenges of the IVDR in the context of clinical trials
- The role of the IVD manufacturer and the role of the clinical trial sponsor
- Conducting clinical performance studies of IVDs
- Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
09:00 - 09:10
Chairperson’s Opening Remarks
- Meg Whittaker - Managing Director and Chief Toxicologist, ToxServices LLC
09:10 - 10:15
Foundations to Biological Evaluations
- The beginnings of the BE
- Intent of a BE
- Definitions and foundations
- Standard intent vs regulator interpretation
- Beau Rollins - Global Director, Quality Services, ConvaTec
10:15 - 10:45
Coffee and Networking Break
Showing 3 of 3 Streams
European Medical Device Regulations
Medical Device Law and Compliance Track
Biological Evaluation Execution and Authorship Training
10:45 - 11:30Free
Lessons Learned by Industry: Documenting Intended Purpose Consistently
- Deciding upon your intended purpose
- Technical documentation
- Where does intended purpose feature?
- Ensuring clarity in your explanation
- Impact of inconsistent intended purposes within documentation
- NB feedback
- Mira Leiwant - Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance, Anika Therapeutics, Inc.
11:30 - 12:00Free
Don’t Wait, Automate! Intelligent Automation for MDR/IVDR Content Success
- MDR compliance deadlines are closer than you think
- MDR compliance requirements are greater than anyone thought – including MDR-related content requirements
- The MDD extension provides manufacturers with a window of opportunity to automate content processes (labeling, marketing, PMS and software) to ensure on-going compliance without additional headcount.
- Marc Miller - Division President, TransPerfect Medical Device Solutions
12:00 - 12:30Free
1 Year On: MDCG 2022-5 Guidance on Borderline Products
- Overview of the guidance
- Practical application and interpretation
- Considerations for a proportionate interpretation
- Industry`s current experience with adhering to the guidance
- Assessing the impact on qualification of medical devices
- Oliver Hartmann - Legal and Regulatory Affairs Manager, Association of the European Self-Care Industry (AESGP)
10:45 - 11:15Free
Preparing for The New Product Liability Directive
- Proposal in the pipeline, how to best prepare in time for the 2024-25 deadline
- How has the deck been reshuffled in terms of liability for importers, authorised representative, manufacturers
- Interpreting the new expanded definition of defect
- Andrew Austin - Partner, Global Co-Head of Consumer & Healthcare, Freshfields Bruckhaus Deringer
- Harriet Hanks - Counsel, Freshfields Bruckhaus Deringer
11:15 - 12:00Free
What will AI mean for Product Liability, Health Data and Submission?
- Legal difficulties surrounding liability: AI as/in a medical device (SaMD)
- Resubmission challenges due to constant changes with ML and AI
- Interaction with EU patient data ecosystem
- Artificial Intelligence Act and new rules surrounding AI Liability Directive, how does it interact with EU MDR
- Josefine Sommer - Partner, Sidley Austin, Belgium
- Monika Zdzieborska - Senior Managing Associate, Sidley Austin
- Ulrich Juknat - Legal Director – Regulatory Law, Johnson & Johnson
12:00 - 12:30Free
Market Access Considerations for Digital Health Technologies
- Thinking through commercialization and market access strategies during the early stages of product development.
- Understanding who will use and pay for your DHT, and in what settings.
- Navigating the kaleidoscope of different reimbursement approaches from country to country.
- Threshold requirements and evidence generation.
- Sarah Cowlishaw - Partner, Covington & Burling LLP
- Raj Gathani - Associate, Covington & Burling LLP
10:45 - 11:30
Process in creating a Biological Evaluation Plan
- Utilizing Design inputs
- How to properly define intended use and device categorization
- Literature search
- How to reference competitive devices
- Clinical evaluation data integration
- Group divisions and BEP creation exercise
- Crystal D’Silva - Manager, Pre-Clinical Toxicology – Global Quality, Baxter
11:30 - 12:30
Test design for BEP
- E&L test requirements and set up
- Correct Dose Base Threshold (DBT) for device
- Calculation of Analytical Evaluation Threshold (AET)
- Method Uncertainty Factor (UF), sensitivity, solvent selection
- Applying to intended use and materials
- Traditional endpoint tests and critical factors
- In-vitro vs In-vivo
- Extraction time, temp, and ratios
- Determining gaps from E&L, literature, etc to determine appropriate endpoint test
- Group division and BEP completion
- Boopathy Dhanapal - Convenor of WG18, ISO/TC 194, ISO
12:30 - 14:00
Networking Luncheon
Showing 3 of 3 Streams
European Medical Device Regulations
Medical Device Law and Compliance Track
Biological Evaluation Execution and Authorship Training
14:00 - 14:05Free
Chairperson’s Afternoon Remarks
- Oliver Christ - Senior Director Health Science EMEA, NSF
14:05 - 14:35Free
Experiences with being the Person Responsible for Regulatory Compliance (PRRC)
- Roles and responsibilities of PRRC within the organisation
- Where they fit within the wider ecosystem
- How you designate role
- How to document effectively
- Utilising your PRRC effectively
- Bettina Möbius - Head of Regulatory Affairs - Quality & Regulatory Affairs, Medical Division, Drägerwerk AG & Co. KGaA
14:35 - 15:05Free
Industry Perspective: Undergoing Conformity Assessments
- Experiences from undergoing a conformity assessment for Low risk class devices (Class I/IIa).
- Is there Technical Documentation unique or specific to these device classes?
- Overcoming challenges relating to clinical evaluation
- Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
15:05 - 15:35Free
Is the EU MDR Extension a Blessing or a Curse?
- What does the extension mean to Manufacturers?
- What are the pitfalls to avoid during the extension?
- Learn how notified bodies are dealing with the extensions – common challenges and advice.
- What is the impact of the extension for legacy versus new products?
- What does this mean for Brexit? How will Switzerland act?
- Joseph-Richardson Larbi - Regulatory Affairs Expert – Medical Devices, Celegence, Celegence
14:00 - 14:05Free
Chairperson’s Afternoon Remarks
- Fatima Sanfourche - Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
14:05 - 14:35Free
Status Update: Overcoming Electronic IFU Labelling Obstacles
- Current regulations outdated, Germany & France lobbying, what work is being done towards updates?
- Strategies to approach IFU labelling; making it easier for manufacturers while keeping to legal requirements
- Impact of the Green Deal: Timeframes, how to prepare, when where what etc.
- Ricardo Rocha - Senior Associate, PLMJ
14:35 - 15:05Free
Legal Guidance around Medical Device and IVD Advertising Standards
- Navigating Article 7 & advertising regulations, social media problems and making the right claims
- Adhering to regulatory requirements while maintaining competition in the field
- The role of article 7 MDR/IVDR in the QMS, PMS and PMCF/PMPF
- Erik Vollegbret - Partner, Axon Lawyers
15:05 - 15:35Free
Developments in Healthcare Data & Privacy: Compliance Considerations and Legal Implications for Device & IVD Manufacturers
- Examining key legal frameworks including the European Health Data Space, Digital Data Act and upcoming Data Act in relation to MDs
- Using existing foundations as a basis for innovation, what needs to change?
- Medical Device Industry considerations for potential opportunities, challenges and pitfalls
- Elisa Stefanini - Partner, Portolano Cavallo
- Laura Liguori - Partner, Portolano Cavallo
14:00 - 14:05
Chairperson’s Afternoon Remarks
- Meg Whittaker - Managing Director and Chief Toxicologist, ToxServices LLC
14:05 - 14:50
Understanding and interpreting test results
- E&L test reports and applying AET for compound analysis
- Acceptance criteria for traditional endpoint tests
- Common deviations
- What to do if you fail
- Boopathy Dhanapal - Convenor of WG18, ISO/TC 194, ISO
14:50 - 15:40
Toxicology Section
- Evaluating compounds
- NOAEL/LOAEL
- Cramer categorization
- Unknown determination
- MOS calculation per ISO 10993-17
- Group division and Tox assessment
- Meg Whittaker - Managing Director and Chief Toxicologist, ToxServices LLC
15:40 - 16:10
Coffee and Networking Break
Showing 3 of 3 Streams
European Medical Device Regulations
Medical Device Law and Compliance Track
Biological Evaluation Execution and Authorship Training
16:10 - 16:40Free
Best Practices: Keeping Technical Documents Up To Date
- Technical Documentation Elements
- Compilation of Tech Doc
- Understanding Key requirements for updating
- How to balance reporting the performance and safety effectively
- Best Practices
- Shaloo Sood - Product Development & RDI Academy, Straumann Group
16:40 - 17:10Free
An Update from the Commission: Current Wins & On-Going Work
- Successes with MDR implementation
- Available guidance
- Extended transition
- Status of certification
- On-going work
- Priorities for 2023/24
- Scientific advice from the expert panels
- The future of MDR
- Flora Giorgio - Acting Head of Unit, D.3 Medical Devices, DG SANTE, European Commission
17:10 - 17:50Free
Industry Panel: Interpreting the MDR
- Notified Body expectations
- Industry’s experiences with receiving Notified Body feedback
- Predictability of feedback
- Impact of misalignment in interpretations
- On-going work to ensure harmonisation
- Gert Bos - Executive Director & Partner, Qserve Group
- Nadine Nasr - Senior Regulatory Affairs Manager, Intuitive Surgical
- Rina Sant - Principal Clinical Scientist EU MDR, Abbott
- Melanie Donguy - Head of Regulatory Affairs, Bayer
- Natasha Bankowski - Director of Regulatory Affairs and Quality Assurance, Beyond Air
16:10 - 17:10Free
Industry Panel: Dealing with Regulatory Change
- How have companies organized to best deal with regulatory changes?
- Industry navigating many simultaneous changes, practical examples
- Ensuring success across market during turbulence
- Erik Vollegbret - Partner, Axon Lawyers
- Phillip Schmidt - Senior Legal Counsel EMEA, Zimmer Biomet
- Janine Reudt-Demont - Counsel, Niederer Kraft Frey (NKF)
- Fatima Sanfourche - Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
- Agnes Szoboszlai - Regulatory Legal Counsel, Philips
16:10 - 16:55
Transitioning into a Biological Evaluation Report
- Addition of all test data and results determination
- Gap assessment to data, deviations, historical testing
- Developing a final conclusion
- Group division and BER completion
- Crystal D’Silva - Manager, Pre-Clinical Toxicology – Global Quality, Baxter
16:55 - 17:45
Life of the Biological Evaluation
- Living document
- Requirements around accuracy
- CCR Impacts and device evolution
- Beau Rollins - Global Director, Quality Services, ConvaTec
17:50 - 18:50
Close of Day One
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