RAPS Euro Convergence 2025

Jens Vandormael has extensive experience in business development within the pharmaceutical sector, currently serving as a Senior Business Development Manager at QbD Group since September 2017, after holding various related positions including Business Development Manager and Project Consultant. Additionally, Jens is an active member of the ISPE Belgium Affiliate emerging leaders board since April 2022, contributing to advancements in pharmaceutical engineering. Prior to these roles, Jens was involved as a Tutor at Sagio.be VZW and as a Master Thesis Student at KU Leuven, focusing on the development of an optical fibre surface plasmon resonance method for monitoring the solubility of aptamer-based medicines. Jens was also a board member of LBK, a student association dedicated to education, during 2016-2017. Educational background includes a degree from KU Leuven, completed in 2017.

As the Business Unit Manager - Regulatory Affairs Pharma at QbD Group, I draw upon over 20 years’ experience in the pharmaceutical industry to provide strategic and operational regulatory affairs support to clients on a variety of global projects across the product lifecycle. Additionally, in my role as Country Manager for QbD Group, I have responsibility for leading and developing the UK team and business.

Seasoned Regulatory Affairs Head with over twenty years in the Medical Device/IVD industry, including ten years in Regulatory Affairs and eight years in leadership roles. I leverage extensive expertise in medical device regulations to address complex regulatory challenges, drive interdisciplinary projects, and align regulatory compliance with business strategy. Dedicated to advancing science and healthcare through strategic growth and innovation.

As a seasoned consultant in IVD regulatory affairs, I specialize in navigating the complexities of the IVD-Regulation 2017/746. With expertise in reviewing and writing technical documentation, I assist clients in ensuring compliance with regulatory requirements. My experience extends to working closely with start-up companies, guiding them through the process of obtaining CE certification from notified bodies.

In May 2024, I obtained my RCC-IVDR certification from RAPS, further enhancing my qualifications and commitment to excellence in the field. I am also the Program/Educational Chair of the RAPS Belgium Local Networking Group.

Sara Peeters graduated from KU Leuven as Ph.D. in Biomedical Sciences. During her Doctoral program, Sara worked closely together with IMEC for the development of point-of-care diagnostic devices. She has written multiple articles published in various international, peer-reviewed journals. After graduating she continued to work at IMEC. In 2013 she joined JSR Micro to support the Life Sciences activities.

Pieter Smits is a seasoned expert in Software as a Medical Device (SaMD) and Medical Device Software (MDSW), with extensive experience navigating both EU and US regulations and standards. His expertise spans MDR/IVDR and FDA compliance, as well as critical standards like ISO 13485, IEC 62304, IEC 82304, ISO 62366, ISO 81001, and ISO 14971. Pieter is particularly focused on the latest AI and cybersecurity requirements shaping the future of the industry.  

With a strong background in project management within the pharmaceutical and medical device sectors, Pieter brings a problem-solving mindset to help organizations implement effective solutions and achieve their goals.  

Passionate about proving that compliance and innovation can coexist, Pieter stays at the forefront of evolving SaMD and MDSW legislation and standards, ensuring businesses are prepared for the future while driving meaningful progress.