Scilife Smart Quality Summit

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.

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.

Are you an asset or gatekeeper in your organization? This workshop will help you assess your quality maturity and explore how Quality aligns with your organization’s mission. We'll use three performance pillars and a 4-step approach to build a strong quality culture, including identifying key influencers and creating alignment.

Christy Mazzarisi is a seasoned Quality Systems Professional with 20 years in pharmaceutical and laboratory sciences. She excels in R&D and manufacturing, specializing in PQS transformation, SOP optimization, and QMS audits.

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.

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.

Discover how Scilife’s eQMS is transforming quality management in life sciences. Join our roundtable to explore how to enhance collaboration and job satisfaction through technology, lead with sustainability, ensure compliance, and adapt to evolving regulations while strengthening resilience.