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.

Susan Neadle joined Johnson & Johnson in 1995. Her distinguished career there includes integral leadership roles in R&D and Quality Engineering, spanning pharmaceuticals, medical devices, and consumer products sectors as well as J&J Enterprise. In her current role, Sr. Director, Global Value Chain Quality Design, she serves as Chair of J&J's Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also leads J&J's cross-sector Combination Products Community of Practice. 

Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet the Combination Products' health authority regulations into J&J's Pharmaceutical sector (Janssen). She has applied her Design Excellence Blackbelt skills to drive and develop significant new products and business impacts. Her leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, J&J's highest honor for innovation excellence. Susan holds numerous patents and publications and frequently speaks in public venues. She is actively engaged in several industry working groups on a range of Combination Products topics, including ASTM International, CPC, EFPIA, AdvaMed, Xavier/FDA Combination Products Summit Planning Committee, PDA and ISPE. She serves as Chair of the ISPE Combination Products Community of Practice and Vice-Chair of the Combination Products Coalition PMSR Working Group. Susan earned an M.S. in polymer science & engineering and a B.S. in biology/chemistry, as well as a Fellowship in the American Academy of Optometry. Prior to J&J, Susan held roles in materials analysis, product development, and commercialization at IBM, Unilever, and Organon Teknika.

Mark A. Chipperfield spent 20 years working within large pharma (GSK, Sanofi Aventis, Novartis, Roche) in the field of drug delivery devices and special purpose packaging. Throughout his career, he has been heavily involved in the development of combination products in several forms: solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, pen-injectors, auto-injectors, dispensers and special purpose applicators. Since 2015, he has been an independent consultant supporting pharma companies, suppliers and device innovators across the globe to develop, launch, and maintain their products.

Mark is responsible for the Health Solutions within Digital Health at TEVA Pharmaceuticals. Over ten years with TEVA and prior to that, sixteen with AstraZeneca. Mark has held various positions, including R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. He graduated in Aeronautical Sciences and completed his MBA at Durham University, UK.

During his career, he has led technology & especially inhaler development teams through engineering, CMC characterization, clinical evidence generation, registration within the US, EU, and International Markets, and ultimately, to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®. The first FDA-approved digital inhaler with built-in sensors.

Mike Wallenstein has over 25 years of experience in QA, R&D, and manufactur­ing within the medical device & pharmaceutical industry with positions as head of quality systems, global head of auditing, and compliance. His is currently director of QA & global head of device & combination product expert network at Novartis International, based in Basel, Switzerland.

At TÜV SÜD Product Service GmbH, Stephanie Göbel is Product Specialist for Art. 117. She is re-joining TÜV SÜD Product Service GmbH – from April 2015 to December 2016 she already worked as auditor within the depart­ment of active medical devices. Apart from her role as auditor, Stephanie has gained experience in various positions within the medical device and pharmaceutical industry for more than 10 years: as development engineer in the field of bioresorbable implants and as quality manager in the field of in-vitro diagnostic devices and drug-device combination products. Regard­ing educational background, Stephanie studied medical engineering at the Technical University Munich (Germany), at the University of Applied Sciences Ulm (Germany) and the University of Bradford (UK); She holds a diploma engineering degree in medical engineering.

Roman Mathaes is a group leader within the Lonza Drug Product Service organisa­tion. He is leading the Lonza particle lab and the container closure integrity testing. In this role, Roman is responsible for particle analytics in drug products and container closure integrity testing of vials and pre-filled syringes and process development of capping/crimping. Prior to this assignment, Roman was working within Roche/Ge­nentech network supporting process development of the commercial manufacturing. Roman is an active member of the European CCI industry focus group and part of the BPOG CCI workstream. Roman is a pharmacist by training and conducted his studies at the University of Marburg and King’s College London. He holds a PhD in pharmaceutical technology from the University of Munich for his work on subvisible particle characterisation.