9th Healthcare Symposium

Wilma Werner is a business psychologist, qualified coach and trainer and has seahorses. In addition to these impressive qualifications, she has ten years of experience as an independent coach, trainer and moderator, she loves storytelling and has a rhetorical repertoire ranging from academic-diplomatic to pithy-Ruhrpott and uses it widely. As a moderator, she will guide our specialist audience through this year's Healthcare Symposium.

Keynote: Cognitive Robots - A New Era of Collaboration between Humans and Machines 

Dr Alexander Blass heads up Operations at NEURA Robotics with a passion for innovation and process optimisation. His career began with a degree in mechanical engineering, followed by a master's degree in aerospace. His doctorate in turbulence research gave him a profound insight into complex dynamic systems. 

At Neura, Dr Blass is also responsible for the balance between turbulent dynamics and structured development. As Head of Operations, he ensures that the company works effectively and continues to develop in order to drive forward technical innovations. Under the guiding principle "we serve humanity", NEURA Robotics is working to expand the capabilities of robots with cognitive abilities so that they can work together with humans in existing environments without complex and costly safety systems to make numerous areas of work more attractive, safer and more social. Look forward to exciting insights into how cognitive robotics will also revolutionise the healthcare sector. 

Market Access & Beyond: How Do I Pick Up Speed Using AI? 

Artificial intelligence (AI) is revolutionizing market access in the pharmaceutical industry by enhancing timing, predictability, and outcomes. This is crucial in a complex landscape with challenges such as regulatory approval, health technology assessment (HTA), pricing negotiations, and patient access programs. AI offers powerful solutions by leveraging predictive analytics, machine learning models, and real-world data integration to address these challenges. It transforms regulatory affairs, HTA, pricing and reimbursement, and patient access programs, with real-world examples and case studies demonstrating its applications. Additionally, AI-driven clinical decision support tools assist doctors in making more informed decisions for their patients. Look forward to a deep dive with Dr. Klaus Suwelack. 

ePIL Pilot Germany: Reaching More Patients with Structured Information 

Electronic product information (ePIL) is becoming the new standard, though it is not yet widely adopted by pharmaceutical companies and patients. The ePIL pilot aims to initiate the necessary change process and explore various use cases to bring the benefits of ePIL to all stakeholders. For example: Current solutions can leverage existing infrastructures, such as Data Matrix Codes, to provide patients with batch-specific information. Learn more during an insightful presentation! 

How Digital Delight Will Keep Us Healthy, Make Us Epic 

Prof. Dr. Koen Kas is a healthcare futurist & delight thinker, professor of molecular oncology & digital health at Ghent University in Belgium, and renowned international keynote speaker. He published his vision in 2 books. ‘Sick no more’ describes how we will transition from reactive sickcare to proactive healthcare. ‘Your guide to Delight’ is a roadmap towards that future introducing our personal digital twin that – with the use of AI - will keep you, and your company, relevant and “young”. His new book will take you beyond disease prevention, will introduce your digital triplet, and will describe how a new way to deal with personal data, on a novel version of the internet, help you to become epic. With his keynote, he will kick off the breakout session of our partner regenold, which will focus on the latest developments in the areas of DTx and AI in the healthcare sector. 

Moderation Breakout Session by regenold

Luisa Wasilewski is a published author and established expert in the field of digital health. With her in-depth industry experience, she combines the perspective of running both successful investments and companies in the healthcare space.

As CEO of Grow Health and Brainwave Hub, Luisa is actively guiding healthcare companies through its digital, patient-centric transformation as well as evaluating investments in healthcare startups. In several advisory board roles, she supports digital health startups in their go-to-market strategies. Prior to that, Luisa was responsible for the development of innovative business models at Heartbeat Labs and advised diverse companies on their digital transformation at Capgemini Consulting. 

Moderation Breakout Session by regenold

Oliver Hilgers is responsible for Digital Health and Innovation at regenold GmbH. With 15 years of experience and more than 300 CE -projects he helps companies with the strategic implementation of CE-requirements for medical software as well as  DiGA/DiPA requirements. As an active member of various European expert and working groups, he has extensive regulatory knowledge, which he passes on in projects, lectures and practice-orientated training courses. Oliver’s true passion lies in helping Digital Health companies bring their innovative software to patients’ computers and smartphones in a safe and efficient manner. 

Taking Digital Therapies to a New Dimension - VR Therapy for Pediatric Patients

Founder and CEO of the multiple award-winning brainjo GmbH, which raised €1 million in investment for a groundbreaking VR application for children with ADHD. With over 6 years of experience in Virtual Reality & Digital Health, he has convinced companies such as Meta, Infineon and Medice.

As an industrial engineer and former ADHD sufferer, he brings radical, innovative methods from Silicon Valley and neuroscience that help him live symptom-free today. Curious, provocative and unconventional? Don't miss his talk to learn how to turn ADHD into a superpower!

Taking Digital Therapies to a New Dimension - VR Therapy for Pediatric Patients

Co-Founder and CEO of brainjo. As a passionate advocate for mental health and neurodiversity, Markus drives the project with the vision of improving the lives of many people with mental illnesses. His academic background in Electrical and Information Engineering with a focus on Artificial Intelligence enables him to bring new innovative methods and approaches to practical DTx applications. 

In his lecture, he will give you a comprehensive insight into the perspective of a startup and explain the challenges and opportunities in developing digital health solutions. 

The Use of LLM in Digital Therpeutics

As managing director, consultant and IT architect, Dr. Kai-Uwe Morgenstern has been accompanying the digital development of the German healthcare system for many years. Among other things, he was significantly involved in the design, evaluation and implementation of technical solutions for the integration, security and interoperability of the ePA with various IT systems. The use of generative AI in the healthcare market is one of _fbeta's core topics.  At the University of Osnabrück, Dr. Morgenstern regularly gives seminars on project management. 

PINK! - Insights into the Successful Journey from a DiGA Provider

Prof. Dr. Pia Wülfing is a specialist in gynaecology and obstetrics and has specialised scientifically and clinically in breast cancer for more than 20 years. After 10 years at the University Women's Hospital in Münster, where she helped to set up the breast centre and the clinical study centre there and habilitated on the subject of ‘Targeted Therapies’ in breast cancer, Prof. Dr. Wülfing headed the oncological practice and oncological day clinic at the largest German breast centre, the Mammazentrum Hamburg, for 10 years. Prof Dr. Wülfing has published numerous original and review articles on the subject of breast cancer and her scientific work has received several awards. Due to coronavirus, Prof. Dr. Wülfing turned her attention to the topic of digital health in 2020. She is the founder of ‘PINK! Aktiv gegen Brustkrebs, an online platform for breast cancer patients. PINK! offers various digital solutions for better information, support, guidance, and care for breast cancer patients. 

Prof. Dr. Wülfing is passionately committed to providing breast cancer patients with the best possible support and guidance through innovative digital health solutions. Her goal is to improve the care and treatment of patients. You can find more information at: www.pink-brustkrebs.de 

Data Consistency through Production, Supply Chain & Regulatory Business Processes 

In the rapidly evolving landscape of global commerce, maintaining data consistency across production, supply chain, and regulatory business processes is crucial for ensuring compliance, efficiency, and quality. This presentation delves into the critical role of Regulatory Information Management (RIM) in achieving this goal, with a particular focus on leveraging Master Data and Core Product Data as foundational elements. 

We will explore how RIM systems facilitate the integration and harmonization of data across various functions, ensuring that information remains accurate, up-to-date, and accessible throughout the product lifecycle. Attendees will gain insights into best practices for implementing RIM frameworks, the benefits of a unified data approach, and the challenges organizations may face in this endeavor. 

The World of Meta for Work. Come and Learn How Immersive Technologies Drive True Business Results - The Pfizer Example 

Kasia is a Client Partner Manager at Meta Reality Labs. In her role, she helps EMEA-based businesses understand the benefits of immersive technologies and the value they bring to organizations. Prior to Meta, Kasia led sales and market strategies for key players in the global IT service industry, such as Canon or Samsung.  

Kasia was raised in Poland, graduated with an M.Sc. from Bocconi University in Milan, and currently lives and works in London. 

When not at work, Kasia will likely be seen at the local Pilates studio or DIY store looking for tools for her next project. She loves cooking and enjoys spending time with her family.  

Building a Bridge from Regulatory Data to Patients: The Global Labeling Process Leveraging Structured Component Authoring 

In the pharmaceutical manufacturing industry, maintaining precise and compliant documentation is critical for ensuring product quality and regulatory adherence. This presentation focuses on the transformative benefits of structured component authoring with Docuvera exemplified through global labelling at Boehringer Ingelheim. You can look forward to exciting insights from and with Dr. Niklas Jänich. 

Moderation of the Panel Discussion: "How will AI change the Pharmaceutical Value Chain in the future?"

Anna Graf is a renowned expert for Web3 and is involved in the development of generative AI, immersive technologies and spatial computing. Since 2010, she has been committed to shaping our society through technological progress, with a strong focus on sustainability and gender equality. After founding a network for female leaders in Northern Germany and setting up a Montessori school, she turned to decentralized communities and became a consultant for various NFT projects. At expanded.art she led as director NFT, she led initiatives that combined the traditional art and collecting world with new practices. Now at Arvato Systems, she advises on digital transformation with a focus on emerging tech. Her career reflects the connection of new technologies to drive transformative change in digital and physical spaces. The convergence of decentralized infrastructure, immersion and GenAI plays a crucial role in this. In 2024 she and her team "Increasing the efficiency of the emergency department using immersive AI" won the Healthcare Hackathon of the UKSH.

Dr. Cecilia Vallet holds a PhD in molecular biology and works at Thescon as a consultant, where she contributes to the company's expertise in regulated industries. She works in critical areas such as quality management, IT system selection, validation, and project management. Cecilia is exceptionally dedicated to computerized system validation of AI technologies and helping clients navigate the complex regulatory landscape. Her expertise lies at the intersection of cutting-edge technology and rigorous industry standards. She ensures that innovative AI systems are compliant and effective in helping clients optimize their operations while adhering to the highest regulatory standards. Cecilia will participate in the panel discussion on Day 1 of the symposium.

Simplify Task Management and Prioritize Work in Paperless Shopfloor

The pharmaceutical industry is struggling with increasingly complex workflows that require efficient and error-free implementation. The common practice of verbal communication or paper documentation leads to high manual effort and error-proneness, resulting in delays, decreasing customer satisfaction, inefficient use of resources and loss of information. To overcome these challenges, we offer an introduction to the implementation of a comprehensive task management system that enables the capture, processing and communication of all types of data.

Efficiency and Quality in Production: Fulfill Your Regulatory Guidance with PRECTAVI®

Quality monitoring is still very time-consuming in many places today. At the same time, although the results obtained are documented, they are rarely available quickly for the next production batch. We show a way that makes the measurement results of individual batches immediately available and thus enables complete documentation.

Andrea Striebel is Product Manager at EXTEDO GmbH, located near Munich (Germany). She is responsible for the Safety Hub and the Quality solution at EXTEDO and works closely with the entire Product Management Team. Before taking over the PM role, she started as Senior Business Consultant at EXTEDO in January 2016 and worked on customer projects. She is not only following the latest developments in pharmacovigilance, but also related to IDMP. Before joining EXTEDO, she worked in the pharmaceutical industry for more than 11 years, focusing on pharmacovigilance topics. First, she was a scientist, and later, she took over the team leader position for global drug safety, incl. graduate plan officer, and in 2011, she became QPPV. In her role, she was responsible for establishing and maintaining the global pharmacovigilance system within the company. Being QPPV, Andrea was also involved in audits, inspections, XEVMPD, and supply chain topics. Additionally, she gave pharmacovigilance training and held presentations at national and international conferences.

At the symposium, you will meet Andrea Striebel, who is an expert in both panel discussions. 

Transforming Healthcare With Generative AI and Knowledge Graphs 

Join us at this Pharma and Healthcare Event to explore the transformative power of graph databases in managing highly heterogeneous and interconnected data. Graph databases create comprehensive knowledge graphs, essential for integrating diverse data sources and handling additional layers of data such as metadata and ontologies. Discover how graph databases synergize with GenAI applications, enhancing data analysis and decision-making across the entire pharma value chain. With 9 of the top 10 pharmaceutical companies utilizing Neo4j, learn how these cutting-edge technologies are revolutionizing drug discovery, clinical trials, patient care, and more. Don't miss this opportunity to gain insights into the future of pharma and healthcare data management. 

Leveraging Data-Driven Approaches for Effective Quality Event Management 

Managing quality related events efficiently and effectively is crucial for maintaining product quality and regulatory compliance. This presentation focuses on the implementation of a data-driven approach to manage any kind of quality event within a Quality Management System (QMS). This also includes change control activities which might be triggered. 

We will explore how systematic processes can transform the way manufacturers react and transparently follow-up on quality events, identify root causes, and implement corrective actions. This data-driven strategy enhances the accuracy and speed of issue resolution and provides valuable insights for continuous improvement. Gain a comprehensive understanding of how a data-driven approach to manage quality events can lead to more robust quality control, quicker resolution times, and overall improvements in GxP relevant processes. 

From Data to Diagnostics

His presentation focuses on the key challenges involved in developing a precision diagnostic AI-based medical device, with a particular emphasis on data acquisition and the associated regulatory processes. The spotlight is on how to source high-quality data essential for training and validating AI algorithms while navigating the complex approval procedures, such as obtaining patient consent and ethical committee approvals