Dublin, June 20, 2024 (GLOBE NEWSWIRE) -- The "European Medical Device & Diagnostics Regulatory, Compliance, Post-Market Surveillance and Vigilance Conference" has been added to ResearchAndMarkets.com's offering.
Empowering Excellence by Navigating the Future of Medical Devices & Diagnostics
In the heart of Dusseldorf, Germany, the European Medical Device & Diagnostics Regulatory, Compliance, Post-Market Surveillance and Vigilance Conference is set to take place on the 14th and 15th of October 2024. This pivotal event gathers professionals, experts, and thought leaders from the healthcare industry, providing a comprehensive platform to explore and navigate the evolving landscape of post-market surveillance and vigilance in medical devices and diagnostics.
As the global healthcare sector continues to witness rapid advancements and innovation, ensuring the safety, efficacy, and regulatory compliance of medical devices and diagnostics becomes increasingly crucial. The upcoming conference stands as a beacon for professionals seeking to deepen their understanding of post-market surveillance and vigilance, exchange insights, and foster collaboration to enhance the overall quality and safety of healthcare practices.
Key Themes
- Regulatory Compliance and Updates: The conference will kick off with a thorough examination of the latest regulatory frameworks impacting medical devices and diagnostics. Attendees can expect to gain insights into recent updates, compliance requirements, and best practices to navigate the complex regulatory landscape.
- Technological Innovations in Surveillance: In an era dominated by technological breakthroughs, the conference will feature sessions dedicated to exploring cutting-edge technologies transforming post-market surveillance. Discussions will cover artificial intelligence, data analytics, and other innovative approaches that contribute to proactive monitoring and rapid response.
- Risk Management and Mitigation Strategies: As the medical field faces an array of risks associated with product usage, speakers and panelists will delve into effective risk management strategies. Case studies and real-world examples will be shared to illustrate successful approaches to identifying, assessing, and mitigating risks in the post-market phase.
- Global Collaboration for Safer Healthcare: The conference will serve as a nexus for professionals to connect, share experiences, and establish collaborative networks. Attendees will have the opportunity to engage in discussions on fostering global collaboration to address common challenges and promote a safer healthcare environment.
- Patient-Centric Approaches: Recognizing the pivotal role of patients in the healthcare journey, the conference will emphasize patient-centric perspectives in post-market surveillance and vigilance. Discussions will center around patient engagement, feedback mechanisms, and the integration of patient experiences into continuous improvement processes.
- Educational Workshops and Interactive Sessions: Complementing traditional presentations, the conference will feature interactive workshops and hands-on sessions. These sessions will provide attendees with practical tools, skills, and knowledge to implement effective post-market surveillance and vigilance strategies within their organizations.
Why Attend?
- Cutting-Edge Insights: Attendees will gain access to the latest and most relevant insights into post-market surveillance and vigilance in the medical device and diagnostics industry. The conference will feature thought leaders and experts sharing cutting-edge information.
- Regulatory Updates and Compliance Strategies: Stay informed about the latest regulatory changes impacting the industry and learn effective strategies for ensuring compliance with evolving standards, including the EU MDR and IVDR.
- Networking Opportunities: Connect with professionals, peers, and industry leaders from around the world. The conference provides an excellent platform for networking, fostering collaboration, and building valuable relationships within the healthcare community.
- Interactive Workshops and Hands-On Learning: Engage in practical, hands-on workshops designed to equip attendees with tangible skills and tools that can be applied directly in their roles. These interactive sessions enhance the educational experience.
- Global Perspective: Gain a global perspective on post-market surveillance by participating in discussions and sessions that focus on international collaboration, harmonization efforts, and best practices from different regions.
- Technology Showcase: Explore a technology showcase featuring the latest advancements in surveillance technologies, AI applications, and other innovative solutions shaping the future of post-market monitoring.
- Patient-Centric Focus: Understand the importance of patient-centric approaches in post-market surveillance. Learn how to integrate patient perspectives, feedback, and experiences into surveillance strategies for improved outcomes.
- Expert Speakers and Panel Discussions: Benefit from presentations by renowned experts and participate in insightful panel discussions. Gain diverse perspectives on key issues and challenges in the field.
- Risk Management Strategies: Learn effective risk management strategies and mitigation techniques through real-world case studies and discussions. Understand how to identify and address potential risks in medical devices and diagnostics.
- Professional Development Opportunities: Enhance your professional development by staying current on industry trends, expanding your knowledge base, and gaining valuable insights that can contribute to career advancement.
- Updates on Unique Device Identifier (UDI) Implementation: Stay up-to-date on the implementation of Unique Device Identifiers and understand their impact on post-market surveillance and vigilance efforts.
- Best Practices in Adverse Event Reporting: Explore best practices in adverse event reporting and signal detection, gaining practical insights into effective reporting mechanisms.
- Insider Information on Industry Challenges and Solutions: Get an insider's perspective on the challenges faced by the industry and discover practical solutions employed by successful organizations.
- Exposure to Emerging Trends: Discover emerging trends in the medical device and diagnostics sector, such as the integration of telehealth, wearables, and personalized medicine, and understand their implications for surveillance.
- Collaboration Across Disciplines: Understand the importance of cross-functional collaboration between regulatory, quality, and clinical teams. Learn how collaboration enhances overall post-market surveillance effectiveness.
- Post-Market Surveillance for Evolving Technologies: Gain insights into post-market surveillance considerations for evolving technologies, including software as a medical device (SaMD), connected devices, and more.
- Inspiration and Motivation: Attendees will leave the conference inspired and motivated, armed with practical knowledge and a renewed sense of purpose to contribute to the advancement of healthcare safety and quality.
- Exclusive Access to Resources: Participants will receive exclusive access to conference materials, resources, and presentations, providing ongoing reference materials for continued learning and implementation.
- Influence the Future of Healthcare: By participating in the conference, attendees become contributors to shaping the future of healthcare, influencing best practices, and driving improvements in post-market surveillance.
Conference Agenda:
Day 1
- Adapting Regulations and Applications for the Changing Medical Medical Landscape
- Keynote Presentation - EU MDR Extension: A Comprehensive Analysis
- The Interplay of Clinical Evaluation: Creating Harmony from Complexity
- Software as a Medical Device
- Navigating EU MDR: Key Mistakes to Avoid in Your Technical File Submission
- Certifying the Future of Medical Devices
- Regulatory Compliance and Updates
- Impact of the EU MDR and IVDR on Post-Market Surveillance Strategies
- Driving Regulatory Excellence: Innovations in PMO Practices" detailing the below topics:
- Achieving Compliance Harmony Across Global Markets in Post-Market Surveillance
- Afternoon Refreshments and Poster Presentation | One-to-One Networking Meetings
- Adapting and Interpreting the New Regulatory Changes
- Strategy for Regulatory compliance of orphan devices for MDR
- Environmental Product Compliance and Regulatory Intelligence for Medical Devices
- Panel Discussion - How have companies organized to best deal with regulatory changes?
Day 2
- Insights and Advice for Dealing with Seamless Manufacturing
- Industry Perspective: Navigating Obligations, Assessments, and Implementation"
- Efficient Data Collection Strategies for European Medical Device Post-Market Surveillance
- What is proactive PMS?
- Evolving Landscape of Clinical Evaluation: Insights and Strategies
- Classifying and Certifying Substance-Based Medical Devices
- Decoding the MDR Requirements
- Delve into the 2022 Amendments to ISO 10993-18:2020 (ISO 10993-18:2020/Amd 1:2022)
- Synergizing Teams: Integrating Clinical Affairs, Risk Management, and Regulatory Affairs for Effective Post-Market Surveillance
- Compliance Demystified: Addressing MDR Requirements for CMR/ED Substances
- Chemical Characterization of Medical Devices: Overcoming Challenges and Enhancing Regulatory Confidence
Speakers
- Federica Malvaso, Post Market Surveillance Lead, Lima Corporate
- Anja Wiersma, Managing Director and Senior Consultant, QARA manager Ad Interim, mi-CE consultancy IVD, PamGene International B.V.
- Amal Peter, Regulatory Affairs Manager, MT Promedt Consulting GmbH
- Zubeyde Kul, Regulatory and Quality Compliance Manager, MDV Europe
- Emmanuelle Whitbeck, Head of Business Development & Marketing, Tilak Healthcare
- Youmna Abboud, Regulatory Compliance Specialist | ISO | Regulatory Intelligence | RAPS Member, Zimmer Biomet
- Giulia Girola, Regulatory Affairs Specialist, Materialise
- Leon Doorn, Chair, NEN
- Stuart Angell, Managing Director, IVDeology Ltd
- Vaso Basinou, Clinical Evaluator and Project Manager (Clinical/Medical/Regulatory Affairs) Clinical Evaluator and Project Manager (Clinical/Medical/Regulatory Affairs), Bactiguard AB
- Karandeep Singh Badwal, Founder, QRA Medical
- Marta Carnielli, Head of Certification IVD, TUV SUD
- Reina Kahwaji, Regulatory Affairs PMO, EMEA Emerging Markets, Zimmer Biomet
- Luigi Cipolleschi, Quality Assurance Manager, Biochemical Systems International S.p.A.
- Heidi Naderi, Principal Regulatory Consultant, Board-Level Strategic Advisor,, External Partner, Lecturer, Compliant Medical Devices Ltd, EU Notified Body, EU and Saudi Medical Device Law.
- Martin King, QA/RA Business Enabler, ISO Lead Auditor
- Ulla Gertig, Senior Consultant | Medical devices | Regulatory Affairs, AKRA TEAM GmbH
- Carmen Martin, CEO & Founder | Principal consultant, CMG MedDev | MD, IVD, MDSW
- Marco Heim, Senior Manager Post Market Analytics | Global Patient Health & Regulatory Compliance,, KARL STORZ
- Harish Chengalvala, RA Professional Environmental Compliance and Regulatory Intelligence, Thermo Fisher Scientific
Who Should Attend:
- Regulatory Affairs Professionals
- Quality Assurance and Control Managers
- Clinical Affairs Specialists
- Medical Device Manufacturers
- Healthcare Compliance Officers
- Risk Management Experts
- Data Scientists and Analysts
- Biomedical Engineers
- Healthcare IT Professionals
- Pharmaceutical and Biotechnology Professionals
- Patient Safety Advocates
- Clinical Research and Development Teams
- Supply Chain and Logistics Managers
- Healthcare Consultants
- Healthcare Executives and Decision-Makers
- Legal Professionals in Healthcare
- Government and Regulatory Agency Representatives
- Academic and Research Institutions
- Startups and Innovators
- Public Health Officials
For more information about this conference visit https://www.researchandmarkets.com/r/5kvuvz
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