Gert Bos, PhD, FRAPS, is CSO, executive director and partner with Qserve Group in the Netherlands. He is an expert in European regulations with 28 years of experience in life sciences, including 15 years as auditor, product reviewer, regulatory specialist, and head of notified body. Bos has been leading the notified bodies in Brussels for many years and has strongly supported the regulatory debate with the EU Commission, EU Parliament, and the EU Council of Ministers. He has a PhD in biomaterial sciences, and postdoctoral degrees in controlled release of drugs and gene therapy. He is a RAPS Fellow, a founding member of the RAPS European Council, a founding board member of the RAPS Netherlands Chapter and the current president of the RAPS Board of Directors.

Website:

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Christelle works in the Regulatory Affairs Office at the European Medicines Agency (EMA) since 2004. As EMA Regulatory Affairs Officer, Christelle is responsible for providing regulatory advice in relation to regulatory matters for medicinal products for human use submitted through the Centralised Procedure. She has, in particular, an active role on topics such as the implementation of the MDR/IVDR requirements for combination products and repurposing of medicines within EMA.

Christelle is closely involved with the EU medicines repurposing pilot conducted by EMA and the network. She was also at the time the EMA representative at Commission Expert Group on Safe and Timely Access to Medicines for Patients (“STAMP”) for the repurposing topic and subsequently became the EMA representative at the Repurposing Observatory Group, which she is now co-chairing with the Spanish Competent Authority.

Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices.

Tim’s current role is to lead the Devices & Digital Therapeutics group within AstraZeneca Global Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s increasing levels of activity in Digital Therapeutics.

Tim is the chair of the EFPIA Medical Devices Regulatory Working Group, as well as an active member of a number of other groups and associations including the Combination Products Coalition and IPAC-RS.

Before joining AstraZeneca, Tim led the Regulatory Affairs group at Valois Pharma (Part of the Aptar Group – a Manufacturer of Drug Delivery Devices) Tim was responsible for Valois’ regulatory strategy and provided technical & regulatory input to new product development.

Sabina Hoekstra-van den Bosch is global director regulatory strategy at notified body TÜV SÜD and acting as representative of TÜV SÜD and notified bodies in regulatory working groups at European level. She is chair of NBCG-Med, the EU Commission’s working group of notified bodies, and vice-president of Team-NB, the EU notified bodies’ association. She is an expert in European regulations. Her 30 years of regulatory experience includes 20 years as pharmaceutical and medical device regulator in the Dutch government, serving subsequently in the Medicines Evaluation Board, Ministry of Health and the governmental organization for clinical investigations, CCMO. She has worked as lead for European regulation for Philips, where she was also involved in EU MDR/IVDR implementation. She was co-founder and chair of the RAPS Netherlands Chapter. She is a RAPS Fellow.

Amanda has 23 years industry experience working at Pfizer R&D UK, Ltd. Amanda’s focus for the majority of those has been providing strategic support to global development programs and lifecycle management for a broad range of medical device, in-vitro diagnostic and drug-device combination products. Amanda is an active participant in a number of Industry Associations, including EFPIA where she is a co-chair on the ERAO and MQEG working groups relating to medical devices and drug-device products. Amanda is also a contributor to ICH working groups and several ISO standard technical committees, which included the ISO 20069 standard for Assessment of Changes to Drug Delivery Systems issued in 2019 and more recently the revision to ISO 11608 series. Her career started as an Analytical Chemist after obtaining a degree in Chemistry, before moving into a regulatory role in 2005.

Thomas is the Senior Director of Global Regulatory Affairs, Regulatory Science, Policy, and Intelligence at Novo Nordisk, responsible for devices, combination products, IVD and Digital Health. He has extensive experience regulating medical devices and combination products in Europe and the US, effectively balancing business goals with regulatory requirements.

As a former Director of Medical Devices at the Danish Medicines Agency and a member of the European Medical Device Coordination Group (MDCG), Thomas has collaborated with the public sector, MedTech industry, and patient organizations to ensure patient safety.

He has also been elected Chair of the Competent Authorities for Medical Devices (CAMD), gaining valuable experience in both national and international forums, including engagements with the EU Commission, EMA, Head of Medicines Agency (HMA), Notified Bodies, Competent Authorities, and patient organizations.

Thomas holds a master’s degree in political science from the University of Copenhagen and has pursued additional education in project management and leadership. He has nearly 20 years of practical management experience.

Currently, Thomas is a member of the EFPIA Medical Devices WG, ERAO group and member of the Board of Medtech Pharma Platform (MPP) and serves on the Programme Committee for DIA/RAPS Combination Products Summit 2027.

Dr Jonathan Sutch is a principal medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 7 years ago.

Susana de Azevedo Wäsch is vice president of quality management, regulatory affairs and medical affairs with Ypsomed AG. She has more than 25 years of experience in medical devices, pharmaceuticals, and biotechnology. Wäsch is experienced in the areas of regenerative medicine, implants, drug-device combination products and infusion pumps. Prior to Ypsomed, she worked at Geistlich Pharma AG, Switzerland; Eidgenössische Technische Hochschule Zürich; Lonza Visp, Switzerland; the European Bioinformatics Institute; and the Center for Advanced Research in Biotechnology. She holds an MSc from the Ecole Supérieure de Biotechnologies Strasbourg, France; a PhD from the Institute of Microbiology at the Swiss Federal Institute of Technology; and an MBA from the Executive School of Management, Technology and Law in St. Gallen, Switzerland.