Smart Quality Summit 2024: Humans and technology leading the way

Event overview

Preparing for the Future of Quality Management

Join us at the Smart Quality Summit 2024 for an immersive exploration of how quality is revolutionizing the life sciences sector by combining human intelligence with advanced technologies. Be at the forefront of the shift towards a more holistic approach to quality.

Innovate

Uncover cutting-edge solutions that blend human intelligence with advanced technologies, reshaping quality standards like never before.

Connect:

Network with peers and leaders who are paving the way forward toward more innovative quality practices in their organizations.

Transform:

Be a catalyst for change. Participate in workshops and sessions to equip you with strategies to implement smarter, more sustainable quality paradigms in your operations.

Our Summit

The fifth wave of quality is coming—are you ready?

The fourth wave of quality emerged with the Fourth Industrial Revolution, marked by the integration of digital technologies like IoT, AI, big data, predictive analytics and cloud computing into manufacturing. But the world is moving fast and is facing immense societal challenges.

A new approach is appearing on the horizon: Quality 5.0.

The image features organic cells to highlight the critical role of the human element as the building blocks in the upcoming fifth wave of quality | Scilife Smart Quality Summit 2024

Interactive panels and keynotes

Engage with global thought leaders who are pioneering the integration of Quality 5.0 in quality management.

Networking
opportunities

Connect with peers who are also passionate about creating more responsive and responsible quality systems.

Join our community of change-makers

Be part of a vibrant community dedicated to making quality a holistic, inclusive aspect of every life science enterprise.

Agenda

Let’s share perspectives

12:00 CET
6:00 EST

Industry 5.0 as a North Star

Explore the vision of Industry 5.0, a future-proof approach that prioritizes sustainability, resilience, and agility through flexible and adaptable technologies. Discover how Industry 5.0 invests in skills, promoting talent, diversity, and empowerment. Understand the role of industry in achieving societal goals beyond jobs and growth.

Lars de Nul, Deputy Head of the "Industry 5.0 and AI in Science" unit at the Directorate-General for Research & Innovation of the European Commission, specializes in sustainable, resilient, and human-centric industries.

13:00 CET
7:00 EST

DigitalHealth, AI and Software—lean regulatory market access now and in future

Explore the impact of digital health, AI, and software on modern healthcare, and the regulatory frameworks that govern them, including FDA, EU MDR/IVDR, IMDRF, and the EU AI Act. We will discuss future regulatory trends, enforcement challenges, strategies for efficient market access, and showcase case studies for successful approaches.

Rudolf Wagner is a Quality and Regulatory expert with over 15 years in life sciences and AI-driven solutions. He has successfully led global teams to achieve rapid certifications and registered medical devices in 132 countries.

14:00 CET
8:00 EST

Mastering Quality: Assess and Remediate Your System

Learn the value of third-party gap analysis to assess your system's state and discover how process mapping can streamline workflows. Understand the importance of team collaboration and revising SOPs for consistent performance and gain insights to maintain high standards and drive continuous improvement.

Kimberly Wallbank, founder of Quality Systems Services LLC, has over 27 years of expertise in guiding pharmaceutical and medical device companies to FDA, EMEA, and ISO compliance.

15:00 CET
9:00 EST

Innovating the Future: Key MedTech Trends Shaping Medical Device Industry

Explore the latest trends in MedTech and their impact on medical device regulations, including FDA’s QMSR and new cybersecurity requirements. Understand evolving regulations for Laboratory Developed Tests (LDTs) and the role of AI in medical devices. Gain insights to ensure compliance and navigate the changing regulatory landscape.

Jennifer Mascioli-Tudor, Founder and CEO of JMT Compliance Consulting, has over 20 years of experience leading quality and regulatory teams at major companies like Johnson & Johnson and GE Healthcare.

16:00 CET
10:00 EST

From Industry 4.0 to Industry 5.0: Europe's Path to Human-Centric, Sustainable, and Resilient Life Sciences

Join us for a roundtable on Europe's transition from Industry 4.0 to 5.0, focusing on sustainability and human-centric technology. Explore how life science companies can redesign value chains using AI, enhance resilience, and adopt regenerative models.
Don’t miss this opportunity to lead the shift towards a more resilient economy.

Karen Taylor founded Deloitte UK's Centre for Health Solutions in 2011, focusing on research and insights in life sciences and healthcare. Previously, she was the Health Value for Money Audit Director at the National Audit Office.

Harsh Thakkar is the CEO of Qualtivate, a consultancy that empowers life sciences to elevate quality management maturity, ensure regulatory compliance, and deploy innovative technology solutions.

Lesley Worthington has 20 years of quality and regulatory experience, degrees in psychology and law, and executive coaching to enhance clients' confidence and communication skills, driving positive organizational impact.