Ana is a Clinical Consultant and Safety Manager at GBA Key2Compliance with a background in bioscience and more than a decade of experience as a pharmacist.
Since joining the Medtech field in 2022, Ana has worked as a CRA and Safety Manager in studies with both medical devices and pharmaceuticals. Working closely with both sponsors and investigators, she has a solid understanding of the realities and challenges on both sides of the table. At Key2Compliance, she plays an active role in strengthening internal quality systems, developing SOPs, and supporting clients with documentation and training materials tailored to clinical and regulatory requirements.
As one of the instructors of our ISO 14155 course, her goals are to make the standard feel relevant and to help participants apply the standard in their day-to-day work. Expect plenty of real-world examples, open dialogue, and practical tools and advice to take back to your own projects.