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 unfold on the 4th and 5th of November 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.
Conference Overview
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.
Agenda
Day 1
08:15 - 08:55 Registration
08:55 - 09:00 Welcome note
09:00 - 09:10 Opening Remarks from the Chairperson
ADAPTING REGULATIONS AND APPLICATIONS FOR THE CHANGING MEDICAL DEVICE LANDSCAPE
09:10 - 09:40 Keynote Presentation - EU MDR Extension: A Comprehensive Analysis
09:40 - 10:10 The Interplay of Clinical Evaluation: Creating Harmony from Complexity
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.
10:10 - 10:40 Software as a Medical Device
Zubeyde Kul, Regulatory and Quality Compliance Manager, MDV Europe
10:40 - 11:30 Morning Refreshments and Poster Presentation | One-to-One Networking Meetings
11:30 - 11:50 Navigating EU MDR: Key Mistakes to Avoid in Your Technical File Submission
Karandeep Singh Badwal, Founder, QRA Medical
11:50 - 12:20 CERTIFYING THE FUTURE OF MIDICAL DEVICES
Regulatory Compliance and Updates
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.
12:20 - 12:40 Martin King
Martin King, QA/RA Business Enabler, ISO Lead Auditor
12:40 - 13:00 Impact of the EU MDR and IVDR on Post-Market Surveillance Strategies
Luigi Cipolleschi, Quality Assurance Manager, Biochemical Systems International S.p.A.
13:00 - 14:00 Lunch and Poster Presentation | One-on-One Networking Meetings
14:00 - 14:30 Driving Regulatory Excellence: Innovations in PMO Practices" detailing the below topics:
Reina Kahwaji, Regulatory Affairs PMO, EMEA Emerging Markets, Zimmer Biomet
14:30 - 15:00 Achieving Compliance Harmony Across Global Markets in Post-Market Surveillance
15:00 - 15:50 Afternoon Refreshments and Poster Presentation | One-to-One Networking Meetings
15:50 - 16:20 ADAPTING AND INTERPRETING THE NEW REGULATORY CHANGES
Strategy for Regulatory compliance of orphan devices for MDR
Anja Wiersma, Managing Director and Senior Consultant, QARA manager Ad Interim, mi-CE consultancy IVD, PamGene International B.V.
16:20 - 16:50 Environmental Product Compliance and Regulatory Intelligence for Medical Devices
Harish Chengalvala, RA Professional Environmental Compliance and Regulatory Intelligence, Thermo Fisher Scientific
16:50 - 17:20 Panel Discussion - How have companies organized to best deal with regulatory changes?
17:20 - 17:30 Closing Remarks from the Chairperson
17:30 - 17:30 Drinks Reception & Networking
Day 2
08:15 - 08:55 Registration
08:55 - 09:00 Welcome note
09:00 - 09:10 Opening Remarks from the Chairperson
09:10 - 09:40 INSIGHTS AND ADVICE FOR DEALING WITH SEAMLESS MANUFACTURING
09:40 - 10:10 Industry Perspective: Navigating Obligations, Assessments, and Implementation"
10:10 - 10:40 Efficient Data Collection Strategies for European Medical Device Post-Market Surveillance
10:40 - 11:30 Morning Refreshments and Poster Presentation | One-to-One Networking Meetings
11:30 - 11:50 What is proactive PMS?
Marco Heim, Senior Manager Post Market Analytics | Global Patient Health & Regulatory Compliance,, KARL STORZ
11:50 - 12:20 Evolving Landscape of Clinical Evaluation: Insights and Strategies
12:20 - 12:40 Classifying and Certifying Substance-Based Medical Devices
DECODING THE MDR REQUIREMENTS
12:40 - 13:00 Delve into the 2022 Amendments to ISO 10993-18:2020 (ISO 10993-18:2020/Amd 1:2022)
13:00 - 14:00 Lunch and Poster Presentation | One-on-One Networking Meetings
14:00 - 14:30 Synergizing Teams: Integrating Clinical Affairs, Risk Management, and Regulatory Affairs for Effective Post-Market Surveillance
14:30 - 15:00 Compliance Demystified: Addressing MDR Requirements for CMR/ED Substances
15:00 - 15:50 Chemical Characterization of Medical Devices: Overcoming Challenges and Enhancing Regulatory Confidence
15:50 - 16:00 Closing Remarks from the Chairperson
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, TÜV SÜD
- 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: Individuals involved in navigating the complex landscape of medical device and diagnostics regulations, ensuring compliance with evolving standards.
- Quality Assurance and Control Managers: Professionals responsible for maintaining and improving the quality of medical devices throughout their lifecycle.
- Clinical Affairs Specialists: Those involved in planning, conducting, and managing clinical trials and post-market clinical follow-up studies for medical devices.
- Medical Device Manufacturers: Representatives from companies involved in the design, development, and manufacturing of medical devices and diagnostics.
- Healthcare Compliance Officers: Professionals overseeing compliance initiatives within healthcare organizations, ensuring adherence to regulatory requirements.
- Risk Management Experts: Individuals focused on identifying, assessing, and mitigating risks associated with medical devices and diagnostics.
- Data Scientists and Analysts: Professionals working with data analytics and artificial intelligence, particularly those involved in leveraging data for post-market surveillance.
- Biomedical Engineers: Those contributing to the development and improvement of medical devices and diagnostics from an engineering perspective.
- Healthcare IT Professionals: Individuals involved in implementing and maintaining information technology systems related to healthcare, especially those supporting medical device connectivity and data security.
- Pharmaceutical and Biotechnology Professionals: Individuals interested in the interface between medical devices, diagnostics, and pharmaceuticals, particularly those working on combination products.
- Patient Safety Advocates: Professionals dedicated to ensuring the safety and well-being of patients through effective post-market surveillance practices.
- Clinical Research and Development Teams: Individuals engaged in the research, development, and clinical testing of medical devices and diagnostics.
- Supply Chain and Logistics Managers: Those responsible for managing the supply chain and ensuring the resilience of the distribution network for medical devices.
- Healthcare Consultants: Consultants providing expertise in regulatory compliance, risk management, and quality assurance within the medical device and diagnostics sector.
- Healthcare Executives and Decision-Makers: Leaders and decision-makers within healthcare organizations who play a role in shaping policies and practices related to medical devices.
- Legal Professionals in Healthcare: Lawyers and legal professionals with a focus on healthcare law and regulatory compliance, especially as it pertains to medical devices.
- Government and Regulatory Agency Representatives: Officials involved in shaping and enforcing regulatory frameworks related to medical devices and diagnostics.
- Academic and Research Institutions: Researchers and academics involved in studying and advancing the field of medical devices, diagnostics, and post-market surveillance.
- Startups and Innovators: Entrepreneurs and innovators working on the development of new and disruptive technologies in the medical device and diagnostics space.
- Public Health Officials: Professionals with a focus on public health and safety, particularly those concerned with the impact of medical devices on the broader population.
Location
ADDRESS
Dusseldorf
Germany
Venue to be announced shortly.
