Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Pia Gyselen

Lead Medical Writer

Pia is an experienced expert with 26 years in the medical industry. She holds a Master’s degree in Medical Biochemistry from the University of Antwerp, Currently, Pia leads the Medical Writing team at QbD Clinical, overseeing the creation of regulatory documents for medical devices, in-vitro diagnostics, and clinical research. She collaborates with cross-functional teams to ensure compliance and accuracy in regulatory submissions. Previously, Pia was the Lead of Clinical Operations at Fluidda, where she shaped the department and managed the team. She also held senior roles at Janssen Research & Development, where she managed large-scale global clinical trials, focusing on strategic planning, risk management, and operational execution. Pia is a lifelong learner who thrives on tackling multiple projects and enjoys brainstorming innovative solutions, mentoring others, and turning ideas into action.