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Agenda 2024
TBC
0830 - 0930 REGISTRATION AND MORNING REFRESHMENTS
0930 - 0940 OPENING ADDRESS
0940 - 1010 RESERVED PRESENTATION
1010 - 1030 SPEED NETWORKING SESSION
- Exchange business cards and get connected in short one-to-one meetings
- Start the conversation to arrange a more formal meeting later on in the conference
- Share your professional background and discuss your biggest business issues – don't forget your business cards!
Conference Host
1030 - 1100 MORNING COFFEE BREAK IN THE EXHIBIT AREA
1100 - 1130 PANEL DISCUSSION ON MEDICAL DEVICE BIOCOMPATIBILITY
1130 - 1200 OPTIMIZING BIOLOGICAL EVALUATION ASSESSMENT USING PREDICATE DATASETS
- Streamlining workflows to address biocompatibility testing during remediation
- Leveraging predicate datasets for chemical and toxicological evaluation
- Applying retrospective data to inform future biocompatibility strategies
Vanessa Tran
Zimmer Biomet
Zimmer Biomet
1155 - 1200 Q&A SESSION ON BIOLOGICAL EVALUATION STRATEGIES
1200 - 1330 NETWORKING LUNCH & VISITING THE MEDICAL DEVICE BIOCOMPATIBILITY EXHIBITION
1330 - 1355 CASE STUDIES AND REGULATORY EXPECTATIONS IN CHEMICAL CHARACTERIZATION OF MEDICAL DEVICES PER ISO10993-18 GUIDANCE
- Delving into updated regulatory expectations and practical strategies for ISO 10993-18 Guidance
- Implementing extraction strategies for devices with long-term or permanent contact
- Analyzing the 2022 amendment on analytical evaluation threshold and method validation
Dujuan Lu
SGS
SGS
1355 - 1400 Q&A SESSION ON CHEMICAL CHARACTERIZATION OF MEDICAL DEVICES
1400 - 1425 A NOVEL APPROACH FOR GENERATING BIOCOMPATIBILITY TEST ARTICLE EXTRACTS AS PER ISO 10993-12
- Discussing challenges in performing extractions for wound dressings as per ISO 10993-12 standards
- Introducing a new method for extracting "hard to extract" wound dressings, comparing pros and cons
- Presenting initial experimental results demonstrating compliance with ISO 10993-12 using the new method
Leah Williams
ConvaTec
ConvaTec
1425 - 1430 Q&A SESSION ON BIOCOMPATIBILITY TEST ARTICLE EXTRACTS
1430 - 1500 AFTERNOON COFFEE BREAK IN THE EXHIBIT AREA
1500 - 1525 A NOTIFIED BODY PERSPECTIVE ON COMMON BIO-COMPATIBILITY COMPLIANCE CHALLENGES
- Providing an overview of bio-compatibility evaluation processes for orthopaedic, ophthalmic, dental, wound care, and active devices
- Highlighting tailored evaluation procedures for each device type, focusing on key factors and common testing methodologies
- Scrutinizing common bio-compatibility nonconformities identified during the EU-MDR technical file review for CE marking of medical devices
Shahriar Sharifi
GMED North America
GMED North America
1525 - 1530 Q&A SESSION ON BIO-COMPATIBILITY COMPLIANCE CHALLENGES
1530 - 1555 VAGINAL IRRITATION TESTING – PROSPECTS OF HUMAN 3D VAGINAL TISSUE MODELS
- Certifying biocompatibility and safety for personal lubricants and medical devices
- Fabricating physiologically relevant in vitro tissue models for screening feminine care products
- Surveying applications of vaginal tissue models in predicting irritation
Seyoum Ayehunie
MatTek
MatTek
1555 - 1600 Q&A SESSION ON 3D VAGINAL TISSUE MODEL APPLICATIONS
1600 - 1700 NETWORKING DRINKS RECEPTION
TBC
0900 - 0930 MORNING REFRESHMENTS
0930 - 0940 OPENING ADDRESS
0940 - 1010 RESERVED PRESENTATION
1010 - 1040 RESERVED PRESENTATION
1040 - 1100 MORNING COFFEE BREAK IN THE EXHIBIT AREA
1100 - 1125 COMPUTATIONAL WORKFLOW FOR SAFETY ASSESSMENT OF DATA-POOR COMPOUNDS AND INNOVATION IN BIOCOMPATIBILITY MET
- Assessing safety: utilizing computational workflows and IVIVE to evaluate data-poor compounds
- Predicting exposure: leveraging the CHRIS Bulk Chemicals model for accurate compound release rates
- Innovating biocompatibility: adopting new methods and fostering an innovation mindset for regulatory approval
Ron Brown
Risk Science Consortium, LLC
Risk Science Consortium, LLC
1125 - 1130 Q&A SESSION ON SAFETY ASSESSMENT AND BIOCOMPATIBILITY METHODS
1130 - 1155 HEALTHCARE COMPANIES STRUGGLE WITH MATERIALS DATA MANAGEMENT IMPACTING BUSINESS OUTCOMES
- Addressing inconsistencies and lack of standardization in material properties
- Mitigating late-stage failures through better material selection and data management
- Streamlining restricted substance compliance across multiple geographies
Matt Rice
Ansys
Ansys
1155 - 1200 Q&A SESSION ON MATERIALS DATA MANAGEMENT IN HEALTHCARE COMPANIES
1200 - 1215 FEEDBACK & RAFFLE DRAW
1215 - 1330 NETWORKING LUNCH
Key topics for 2024:
-
Trends and innovations in biocompatible devices in healthcare
Discover the latest biocompatibility trends in the medical device lifecycle, from development to after-use. -
Assessment of medical devices using innovative testing methods
Evaluate biocompatibility, functionality, safety, performance, and environmental factors using state-of-the-art testing techniques. -
Advancing post-market surveillance of medical devices
Leverage cutting-edge technologies, such as artificial intelligence and data analytics, to transform the post-market surveillance of medical devices. -
Latest research on identifying and assessing carcinogens
Explore research on potential carcinogens, concern cohorts, and degradation products in medical devices and assess their impact. -
Case studies on biological evaluation plans under guidance
Enhance your understanding of evaluation studies to evaluate medical device compatibility with biological systems. -
Upcoming biocompatibility regulations in the healthcare industry
Stay informed about emerging regulations impacting the biocompatibility of medical devices and toxicology assessments for clinical trials.
Sponsorship Opportunities
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