Key topics on this year’s agenda include:

1. Advances in Biocompatibility Testing

• Next-generation biocompatibility assessment techniques.
• 3D tissue models and in vitro systems for predicting biological response.
• Integration of AI and machine learning in biocompatibility analysis.
• Personalized medicine and its impact on biocompatibility standards.

2. Innovations in Toxicology

• Novel toxicology testing methods, reducing animal testing.
• Predictive toxicology: Using omics and data-driven approaches to predict toxicity.
• Development of new toxicity biomarkers for early detection.
• Toxicological risk assessments for combination products and nanomaterials.

3. Extractables & Leachables (E&L) – Emerging Trends

• Updated methodologies for E&L testing in pharmaceutical packaging and medical devices.
• Regulatory challenges for E&L in global markets (FDA, EMA, ISO updates).
• E&L in biologics and cell-based therapies: Addressing new challenges.
• Case studies on complex materials and advanced packaging systems.

4. Regulatory Landscape and Compliance

• Overview of recent global regulatory changes (FDA, EMA, ISO 10993, ICH Q3E).
• Best practices for navigating evolving E&L regulations.
• Bridging the gap between biocompatibility and regulatory requirements.
• Strategies for compliance with evolving environmental and chemical regulations (e.g., REACH, EU MDR).

5. Material Science and Biocompatibility

• Innovations in materials science: New biocompatible materials for medical devices and drug delivery systems.
• Role of polymers, coatings, and composites in enhancing biocompatibility.
• Biocompatibility of sustainable and eco-friendly materials.

6. Risk Management and Safety Assessment

• Risk-based approaches to biocompatibility and toxicology evaluation.
• Holistic safety evaluation: Balancing biocompatibility, toxicology, and E&L risks.
• Integrating risk management frameworks in product development cycles.

7. Sustainable Packaging and E&L Implications

• E&L considerations for eco-friendly and biodegradable packaging materials.
• Challenges and solutions for sustainable packaging in pharmaceuticals.
• Long-term impact of leachables in reusable and multi-use medical devices.

8. Innovative Approaches to Extractables & Leachables Testing

• Novel analytical technologies for detecting E&L in low concentrations.
• Automation and miniaturization in E&L testing workflows.
• High-throughput screening methods for complex leachables.

9. Case Studies and Real-World Applications

• Real-world case studies on E&L testing in complex products.
• Success stories and lessons learned from biocompatibility failures and recalls.
• Interactive panels on troubleshooting and optimizing E&L processes.

10. Future of Biocompatibility and Toxicology

• The role of big data and digital transformation in biocompatibility and toxicology.
• Predicting future trends in biomaterials and their biocompatibility.
• Collaborative approaches to tackle global biocompatibility and toxicology challenges.

Who should attend?

• Academics and Researchers
• Healthcare Professionals: Physicians, surgeons, and other medical practitioners
• Post-Market Surveillance Experts
• Consultants and Industry Experts in the field of medical device biocompatibility and toxicology
• Risk Management Specialists
• Biocompatibility Specialists: Experts who assess the compatibility of medical devices with biological systems and tissues
• Medical Device Manufacturers
• Toxicologists
• Effects of medical devices and their components
• Regulatory Affairs Professionals
• Quality Control/Quality Assurance Professionals
• R&D Scientists and Engineers
• Testing Laboratories

Target Market and Audience

1.     Pharmaceutical and Biotech Companies

• Roles: R&D Scientists, Toxicologists, QA/QC Specialists, Regulatory Affairs.
• Relevance: Ensure safety, efficacy, and regulatory compliance of drug products, including E&L and biocompatibility testing.
• Medical Device Manufacturers
• Roles: Product Engineers, Material Scientists, Compliance Officers.
• Relevance: Focus on biocompatibility and safety of devices, keeping pace with regulatory changes.
• Packaging and Material Science Companies
• Roles: Packaging Engineers, Material Scientists, Chemical Engineers.
• Relevance: Ensure packaging materials meet safety and compliance standards for E&L.
• Contract Research Organizations (CROs)
• Roles: E&L Testing Experts, Toxicologists, Chemists.
• Relevance: Provide specialized testing and compliance services for pharmaceutical and device companies.
• Regulatory Agencies
• Roles: Inspectors, Policy Makers, Compliance Experts.
• Relevance: Provide insights on guidelines, compliance, and safety standards.
• Analytical and Testing Laboratories
• Roles: Analytical Chemists, Lab Managers, E&L Scientists.
• Relevance: Conduct E&L testing and biocompatibility assessments using advanced methodologies.
• Healthcare Product Manufacturers
• Roles: Product Safety Managers, Testing Experts.
• Relevance: Ensure long-term safety of packaging and materials in healthcare products.
• Academia and Research Institutes
• Roles: Professors, Researchers, PhD Students.
• Relevance: Contribute to research advancements in biomaterials, toxicology, and E&L.
• Consultants and Industry Experts
• Roles: Regulatory Consultants, E&L Specialists.
• Relevance: Offer expertise in compliance and risk mitigation strategies.
• Industry Associations and Standards Organizations
• Roles: Representatives from ISO, ASTM, etc.
• Relevance: Shape and update industry standards for biocompatibility and E&L.

What to expect?

During the two days of the BSCI Summit 2025 Mon Bien willprovide an exclusive, focused environment where speakers and delegates engage deeply on industry-relevant topics. Our sessions, built around carefully selected case studies based on extensive market research, ensure practical insights and real-world applications. With interactive panel discussions and Q&A sessions, you’ll have the opportunity to get your questions answered directly by experts. Delegates, Speakers & Exhibitors  will leave with valuable new connections, enhanced knowledge, and actionable strategies to drive their professional growth.

24 APR, 2025 08:30

European power sector has been facing major changes in the recent years and the years to come to follow Europe’s low carbon future. Decommissioning of fossil fuel power plants between now and 2030 is necessary for the biggest power generation companies that are all struggling to respond to multiple challenges, regulatory and financial pressures, to follow the phase out.
Mon Bien events is offering this tailor-made forum with a focus on what is needed to plan the phase out of fossil fuel generation assets and further the demolition process, bringing together the best minds from the top power generation companies along with the Engineering Consultancy and top contractors with the highest safety records, Taking part in the forum will undoubtedly allow participants to increase their understanding, the ins and out of the whole process.