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In-Person Seminar | 8-9 October, 2024
London, UK
In-Person Seminar | 8-9 October, 2024
London, UK
Explore the Future of Medical Device Compliance: Harness AI and Master New Regulations
Unleash a comprehensive understanding on the latest updates regarding post-market surveillance and vigilance reporting requirements, emphasizing the transformative role of Artificial Intelligence
Early-Bird: Save £200!
Save £200 per pass when you register by 2 August 2024
Comprehensive Insights On Tap for this Year's In-Person Seminar
Regulatory Insight and Implementation Strategies
Kickstart the seminar with a thorough review of current EU and UK regulatory frameworks, understanding how Brexit has reshaped compliance landscapes and explore the strategic timelines for adopting new regulations up to 2030.
Advanced Surveillance Techniques
Delve into the essentials of Post-Market Surveillance (PMS), from understanding its significance in regulatory compliance to dissecting legal obligations and operational risks. Discussions will include the intricate balance of benefit/risk evaluations and the essential roles of competent authorities.
Critical Role of Clinical Data and Vigilance
Gain insights into the crucial processes of collecting and analyzing clinical data through Post-Market Clinical and Performance Follow Ups and how these integrate with Clinical Evaluation Reports. The session will cover vigorous approaches to managing and reporting adverse incidents.
Technological Advancements in PMS
Day two will focus on practical applications, including setting up efficient PMS systems leveraging the latest in digital and AI technologies for data management and information retrieval.
Future Directions and Compliance Dynamics
Explore how global trends and technological advancements are set to influence future compliance practices in medical device surveillance. Engage with experts during our extended Q&A session, sharing challenges and innovative solutions.
Why Attend This Seminar?
This seminar is designed for regulatory professionals, quality assurance specialists, and anyone involved in the lifecycle of medical devices who seeks to enhance their knowledge and skills in the evolving landscape of medical device regulations and technology.
Expert Guidance:
Benefit from Mika Reinikainen's extensive experience and insights into both the legal and practical aspects of medical device regulation.
AI Integration
Learn how AI can be strategically implemented to enhance the effectiveness of PMS systems, offering greater predictive power and operational efficiency.
Interactive Sessions
Enjoy hands-on sessions and real-life case studies to better understand the complexities of vigilance and crisis management in the medical device field.
Networking Opportunities
Connect with industry peers, expand your professional network, and share insights in an interactive, collegial environment.
Who is this course for?
This course is relevant to medical device and IVD regulatory affairs professionals who wish to develop their understanding of PMS and vigilance:
- Post Market Surveillance
- Vigilance
- Regulatory Affairs
- Global Regulatory Affairs
- Safety specialists
- Compliance Managers
- Quality Assurance
- Quality Compliance