Bjarne Sørensen is a director of front-end innovation at Phillips-Medisize, based in the company’s development centre in Denmark. With more than 35 years of experience within product, strategy, and business development, Bjarne has a very visible track record within different business areas. At Phillips-Medisize, he participates in customer projects, typically involving electronic injectors and connected health systems. He is also deeply involved in new electronic platform programs, especially on conceptual, technical, and sustainability aspects.

Dr. René Dathe, MBA is currently Head Quality Digital Therapeutics and Connected Heath at Novartis. He is accountable for E2E Quality DTx and CH portfolio (Development projects and Commercial products) and Connected Health Ecosystem QMS.

He was Head Quality Medical Device Sandoz Development and LCM at Novartis Global Drug Development for last 3 years. Prior to his engagement, he worked as Project Manager for global alliances (Cardiovascular & Metabolic, Immunology & Inflammation) and Scientist (Diabetes R&D) at Sanofi.

René Dathe obtained his Diploma (M.Sc.) in chemistry at TU Chemnitz, followed by an MBA in Frankfurt. He was awarded a doctorate in business administration by the University of Gloucestershire, UK for his research work on medical device innovations.

Paul Johnson is an independent consultant to the pharmaceutical industry who has specialised in the CMC aspects of NCE and generic inhaled product development since 2018 serving clients in large/small pharma companies, pharmaceutical component suppliers, and pharmaceutical service providers.

Paul gained 20 years of experience leading teams and projects involved for the development of inhaled products at Glaxo Smith Kline in a range of delivery systems, including dry powder inhalers, pressurised metered dose inhalers, and nebulisers. He is most proud to have led the CMC teams from early development, through clinical stages, registration, launch and lifecycle management for Relvar/Breo Ellipta, and provided leadership for the CMC aspects for the entire GSK inhaled franchise.  

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device and pharmaceutical industries. Yvonne leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations. Yvonne holds a BSc in industrial design and an MSc in human technology interaction, both from Eindhoven University of Technology (NL).

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan leads Global Pharma clients in complex compliance projects to meet the latest regulatory requirements. In his role as Managing Director at Beyond Conception, Juan has pioneered efforts in Combination Products in Europe by leading clients to obtain Notified Body Opinions as well as achieving compliance with the EU MDR and EU IVDR and other global regulations. His insights of the EU framework on medical devices and combination products and experience in Notified Body interactions and submissions have made Juan a constant speaker at leading conferences. His focus is on creating value beyond compliance and understanding thoroughly business needs to the deliver the highest value to his clients.

Patrice Becker is a medical device industry expert with more than 30 years of experience in clinical and medical affairs. He holds a masters degree in pharmacology and a masters degree in business administration for pharmaceutical and biomedical companies. After several years of experience in small medical devices companies, he joined Biomatech a consulting and testing company focused on medical devices testing  as a clinical research manager . Then he joined  Sofradim/Medtronic in 1998, building and taking the lead of the clinical research department for 13 years. then he was the leader of the scientific communication department for abdominal and robotic surgery until february 2023.  He is now leading activities for St Gilesmedical in France. St Gilesmedical is a scientific communication and medical writing independent company based in London and Berlin.

Jakob Lange is Head of Account and Business Development at Ypsomed with responsibility for all sales, customer relationships and marketing activities in the B2B Delivery Systems business.

Prior to his current role, he has held different positions within marketing and sales as well as in R&D project management. He has been with Ypsomed for more than 18 years.

Jakob holds an MSc degree in chemical engineering from the Royal Institute of Technology in Stockholm, Sweden, and a PhD in polymer science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 40 peer-reviewed papers on medical devices, packaging materials, and polymers, and is a regular contributor to conferences on these topics.