DAY TWO
DAY TWO
- Stephanie Seidel - Senior Principal Regulatory Affairs Specialist, Robotic Surgical Technologies (RST), Medtronic
- Identifying the necessary documentation for medical device certification in the US
- FDA expectations
- Best practices for documentation compilation
- Preparing for FDA inspection and consultations
- Post-approval
- Responsibilities and processes for manufacturers
- Shikha Malik - Senior Regulatory Affairs Specialist, Medtronic
- Current status of MDR across Europe
- Implementation status
- Transition deadlines
- Current devices certified
- Industry best practices
- Working with all stakeholders
- Utilizing guidance
- Pathway to approval
- Paul Piscoi - Scientific Policy Officer, D.3 Medical Devices, DG SANTE, European Commission
Join us for an illuminating 'Ask the Expert' session featuring Dr. Jaishankar Kutty, a guiding light in medical device development, regulatory compliance, and clinical strategy. Currently, as the Vice President of Intelligence and Innovation at RQM+, Dr. Kutty is at the forefront of crafting pathways for innovative healthcare solutions.
In this session, participants will have the unique opportunity to engage with Dr. Kutty, whose deep-rooted experience as a former Technical Team Manager and Clinical Team Leader at BSI has made him a sought-after authority in the industry. Dr. Kutty's specialization in cardiovascular products and his instrumental role in the CE marking process will serve as a guiding light for those interested in understanding the intricacies of medical device commercialization and the criticality of regulatory approvals.
- Jaishankar Kutty - Vice President, Intelligence and Innovation, RQM+
- Understanding the global medical device landscape
- Streamlining regulations and expectations globally
- Harmonization initiativeso IMDRF
- GHWP
- MDSAP
- Pre-market and post-market priorities
- Vaibhav Sivaramakrishan - Regulatory Affairs, Terumo Medical Corporation
- Neil Mafnas - Senior Program Management Officer, FDA
- Outlining the differences
- Stakeholders involved in the US and European regions
- Differences in regulatory frameworks
- UK and Swiss markets
- Experiences of submitting in both regions
- Is it possible to streamline 1 submission for both regions?
- Common misconceptions for submitting in EU from US manufacturers
- Harmonization initiatives
- MDSAP
- IMDRF
- Future collaboration and impact on industry
- Neil Mafnas - Senior Program Management Officer, FDA
- Monica Shah - Director, Clinical Affairs, Medical Science, Intuitive
- Bill Kurani, MSRA, MSEE - Head of RA/QA, Genomics, Agilent Technologies, USA
- Choosing the PRRC
- Which team should they sit in?
- Perceived workload of role
- Relationship with regulators
- Utilizing point of contact effectively
- Importance of PRRC in international markets
- Ella Helgeman - Director, Regulatory Affairs and Quality Assurance Team, Nowwell AS & Team PRRC Representative for Norway
- Technical documentation in the EU and US
- Similarities and differences in requirements
- Streamlining documentation to be relevant for both
- Structure of technical documentation
- Ordering documentation for clarity
- Linking documentation to Quality Management Systems
- Ibim Tariah Ph.D - Technical Business Development Director – Medical Devices, SGS North America
- Rachel Chu - Quality Engineering Manager, Verily
- Rob Shulfer - Global Biocompatibility Director, Abbott
- Latest amendments to ISO 10993
- Revisions to ISO 10993-1
- Status of –17 draft implementation
- Interaction of ISO 10993 and other regulations
- FDA
- EU MDR
- Upcoming amendments for 2024/25
- Danny Oseid, PhD - Medical Health Services - Expert, Biocompatibility, TÜV SÜD
- Current perceived impact on industry from latest amendments
- Study design considerations
- Expectations of Regulatory Authorities and Notified Bodies
- End to end toxicological risk assessment process
- Link to extractables & leachables, & toxicological screening limit
- Rob Shulfer - Global Biocompatibility Director, Abbott
- Frances Hsia, MS, MPH, DABT - Toxicologist Fellow, Boston Scientific
- Xiaoling (Sharlene) Dai, PhD, DABT - Senior Principal Toxicologist, Abbott
- Jean Bendaly, PhD, DABT - Principal Toxicologist, Medtronic
- Chemical Characterization and AET derivation
- Selection of DBT/TTC based on ISO/TS 21726:2019
- Why Threshold of toxicological concern (TTC) limit exclude cohort of concern (CoC)?
- Practicable use of TTC values for the CoC
- Compound-specific risk assessment for CoC
- Raini Dutta - Principal Toxicologist, Stryker
- Demonstrating “same-ness” to a legally marketed device
- Raw materials and manufacturing rationales for metallic devices
- The thrombogenicity decision tree
- Rob Allen - Regulatory Affairs – Biocompatibility, MCRA
- Latest updates to ISO 10993-18
- Analytical science expectations of chemical characterization from the perspective of a quantitative “global” space of extractables and leachables in volatility, hydrophobicity, and molecular weight
- A critical review of the current state of analytical testing strategies, including the best practices
- A critical overview of the major analytical challenges in solvent choice, sample treatment, mass balance, method sensitivity (AET), response factor (UF), exhaustion determination, accuracy of quantitation and identification, etc, with specific examples
- Tips for choosing an analytical partner to conduct your works
- Jianwei Li - Chemical Characterization Consultant and Technical Writer, Chemical Characterization Solutions, LLC
- Requirements of ISO 10993-18 in relation to substances which are CMR or have ED
- Risk justification and labelling
- Test design – test type, timing, analysis
- Xiaoling (Sharlene) Dai, PhD, DABT - Senior Principal Toxicologist, Abbott
- Stephanie Seidel - Senior Principal Regulatory Affairs Specialist, Robotic Surgical Technologies (RST), Medtronic
- Breaking down laws – which applies to Software as a Medical Device (SaMDs), Artificial Intelligence and Machine Learning?
- MDR
- FDA
- AI Act
- Competent Authority perspective
- Expectations
- Utilizing your competent authority in SaMD and AI/ML development and certification
- Gloria Nyankima - Biomedical Engineer, FDA
- Sravani Sreeram Nagasai - Technical Program Manager, Google
- Bunty Kundnani - Head of Regulatory Affairs, Qure.ai
- Bill Kurani, MSRA, MSEE - Head of RA/QA, Genomics, Agilent Technologies, USA
- Ed Woo - Regulator Affairs Lead, APAC, Philips
- Overview of current DDCP regulations
- 2 years post-Article 117
- How have all stakeholders adjusted?
- How does Article 117 under MDR differ from FDA regulations?
- Navigating the ongoing 4-year grace period
- Forecasting future regulatory plans for combination products globally
- Maria Colon - Regulatory Strategist, Pfizer
- What are the most common regulatory submission preparation pathways?
- What are the concerns regarding the current method?
- Where do regulatory submission and AI interlink?
- Regulations and standards to be aware of
- Using AI to meet global submission requirements
- Which parts of the regulatory submissions process can utilize AI?
- How can it help streamline global submissions
- Practical tips for implementation
- Resources and help available to the industry
- Priya Paul - Founder & CEO, RegDesk
- Current global UDI implementation status
- GUDUDI
- EUDAMED
- Key challenges with implementation
- Data handling
- Future of requirements – a streamlined approach?
- Bill Kurani, MSRA, MSEE - Head of RA/QA, Genomics, Agilent Technologies, USA
- With MDR having been extended, what impact is there on all stakeholders
- Competent authority and notified body capacity
- Do all devices qualify for the extension?
- Terms and conditions of extensions
- Impact for newcomers and on innovation
- The next few years in light of new extensions
- Knock on effect for wider global markets
- Ibim Tariah Ph.D - Technical Business Development Director – Medical Devices, SGS North America
- Jessica Smith - Corporate Vice President and Chief Regulatory Officer, Integra Lifesciences
- Shikha Malik - Senior Regulatory Affairs Specialist, Medtronic
- Beau Rollins - Director, Quality Services, ConvaTec
- Methods for collecting material information
- Internal/direct
- Third party compliance services
- What are the benefits and risks of various types of material information?
- SDS
- Supplier declarations
- Full material disclosures
- Testing
- Incorporating material information to support biocompatibility needs
- Lauren Kucera, PhD - Global Manager, Material Science and Regulations, COOK Medical
- Design aspects for consideration
- When do you need to test?
- How much is required?
- Which endpoints and risk need to be considered?
- Leveraging data
- Link to legacy products & other similar products
- Christina Schultz - Senior Biocompatibility Toxicologist, Boston Scientific
- Expectations of data for varying device classes
- Legacy devices
- Data assessments
- Preparing for Notified Body audits
- Common misconceptions and how to overcome
- Case study: successful data justification
- Anne Barber - Biocompatibility Scientist, Cardinal Health
- ISO 11607-1 and –2 contribution to establishing shelf life
- Strategy development for addressing shelf life of high-risk products
- Key touch points and common mistakes
- Harvesting and utilizing shelf-life data
- Defending shelf life in terms of biocompatibility testing
- Ming Mo - Tech Lead - Senior Biological Safety Engineer, Philips
- Top regulatory priorities for the next 5 years
- ISO update pipeline
- Linking with other global regulations
- Areas to watch for industry
- Futuring proofing the biocompatibility workforce
- Ming Mo - Tech Lead - Senior Biological Safety Engineer, Philips
- Xiaoling (Sharlene) Dai, PhD, DABT - Senior Principal Toxicologist, Abbott
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group, LLC
- Anthony Ragheb, PhD, MBA - Vice President Global Research and Testing, Cook Medical
- Matthew Jorgensen - Toxicologist, Global Biocompatibility, Teleflex