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.

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan was leading 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.

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.

Dr. Troels Keldmann has spent 25 years in the DDS devices and medical devices industry, working cross-functionally covering development, sourcing, innovation, IPR strategy, business development, partnering, and commercialisation. As interim technical lead on injection devices at LEO Pharma A/S, he headed identification, evaluation, and selection of SC injection devices. His prior DDS experience includes co-founding and heading innovative DDS startups, and consulting in DDS devices for pulmonary, nasal, SC (needle/needle-free), and IM delivery. He is an appointed business coach by the European Innovation Council and an industry fellow at Technical University of Denmark. He holds a BSc, MSc and PhD in mechanical engineering and innovation, as well as an MBA.

Anja Wiersma, is a medical biologist by training with a PhD in the NeuroPharmacological –Behavioural - Physiology field. After working for 8 years at a multinational Pharmaceutical company (Organon), first as scientific researcher and later as a Strategist in Strategy and BusinessDevelopment department, she started to work for a Notified Body in the field of Medical Devices and In Vitro Diagnostic Medical Devices. She was working for this notified body for 6.5 years.

She is fully qualified as a notified body auditor for the Medical Device Directive (MDD 93/42/EEC), Medical Device Regulation (MDR EU 2017/745) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC) and for the In Vitro Diagnostic Device Regulation (IVDR EU 2017/746). Since 2010 she is a RA/QA consultant for medical device and in vitro diagnostic device manufacturers, and she remains a contractor for several notified bodies executing design dossie reviews and CE and ISO 13485 audits as well as for executing inspections for independent organisations.

Furthermore, as of Jan 2013 until Aug 2015 she was a part time QA/RA director and part of management team of an IVD company in the Netherlands. Since March 2015 she is member in the board of the RAPS Netherlands Chapter. From March 2017, until 31 December 2024 she was the chair of the board of the RAPS Netherlands Chapter. And as of September 2017 until September 2020, she was a member of the REC as well (RAPS European Council).

As Managing Director at KAHLITY, Mélodie Kahl has two decades of hands-on experience in quality management, regulatory affairs, and project leadership for pharmaceutical and medical device organizations.

Mélodie has led global compliance programs, guiding clients through technical file development and remediation, designing and implementing quality management systems, and managing successful product launches.

With an Executive MBA in Sustainable Business, Mélodie combines thorough regulatory expertise with forward-looking strategies for drug-device combinations, AI-driven healthcare, and connected device solutions.

Her proven track record includes auditing multinational supply chains, consolidating post-acquisition operations into unified QMS frameworks, resolving critical issues from warning letters, and providing Swiss/EU Authorized Representative services. With KAHLITY’s ISO 13485 certification, Mélodie takes a flexible, tailored approach to align each client’s goals with robust compliance standards, consistently delivering transformative results in competitive markets.

Dr. Daniel Latham is the Strategic Advisor at KAHLITY, bringing over 25 years of experience in drug-device combination product development, connected health solutions, and life cycle management (LCM).

Formerly Head of Device Development & LCM at Novartis, he led large-scale teams and led multiple approvals for biologics, biosimilars, and cell & gene therapies.

Daniel earned his Ph.D. in controlled drug delivery from Queen Mary, University of London. He pairs advanced R&D expertise with an entrepreneurial mindset to drive patient-focused innovation, spanning AI-driven device connectivity, strategic portfolio management, and global regulatory requirements. His flexible, results-oriented approach ensures solutions are both commercially viable and future-ready.

With a proven track record of bridging scientific rigor and business needs, Daniel excels at forging cross-functional partnerships to streamline product development, accelerate time-to-market, and enable sustainable growth in competitive markets.

Mehul Desai, PharmD, MBA, has vast experience in medical and clinical affairs across the pharmaceutical space. At Enable Injections, he leads medical and clinical programming to support publication, new partnerships, and regulatory approvals. Prior to Enable Injections, Mehul served as Associate Medical Director for argenx, driving the strategic direction, supporting clinical trial execution, and contributing to business development activities across various therapeutic areas. Previous experience includes field medical assignments in rare disease, nephrology, and neurology for Mallinckrodt Pharmaceuticals, nephrology and hematology for Alexion Pharmaceuticals, and post-doctoral fellowship work in Medical Affairs for Johnson & Johnson. Mehul also served as a clinical instructor of Pharmacy Practice and Pharmacy Administration at the University of the Sciences in Philadelphia.

Mehul is a published author in peer-reviewed journals, focusing on drug formulation and on-body delivery systems. He regularly delivers podium presentations at industry conferences, contributing to scientific discussions on novel drug delivery technologies.

Mehul holds a bachelor’s degree in Biochemistry and Business Foundations from Indiana University, Bloomington, a Doctor of Pharmacy from Purdue University, and a Master of Business Administration in Pharmaceutical and Healthcare Business from the University of the Sciences in Philadelphia.

Kevin Brunet is currently leading the Device Devlopment and Primary Packaging Quality group at UCB.
During the last 12 years, he has developed a strong expertise in the development and manufacturing of Medical Devices and Drug-device combination products with roles in R&D, Supply chain, Operations and Quality.
His main expertise lays within Design and Development, Risk Management, Supplier Audits and Management with track records of innovative products brought to approval and launch (including N.B. Audits and H.A. Inspections).

Kewei has 13 years industry experience in Novartis, Roche and WuXi biologics in Switzerland, specializing in parenteral formulation& process development, high concentration formulations, long-acting delivery formulations, as well as combination products such as pre-filled syringe, and extending to CMC management for biologics.

Kewei obtained his Bachelor and Master degrees from School of Pharmaceutical Sciences in Peking University, PhD degree from University of Jena in Germany, focusing on pharmaceutical technology and drug delivery. He has published many research papers during his study and work.