Clinical trial translations can be intimidating – especially when you’re faced with rigid structures, recurring phrases, and terminology that feels more regulatory than readable. But what if you knew exactly where that language comes from, why it’s used, and how it’s supposed to sound?

In this talk, Kathrin Kunze, ER-Nurse and Medical Linguist, unpacks the regulatory frameworks that shape the way we translate clinical trial documents – from Clinical Trial Agreements (CTAs) and protocols to Informed Consent Forms (ICFs). After completing a course in Clinical Data Management to better understand the full trial process, Kathrin brings a well-rounded perspective that bridges clinical, regulatory, and linguistic insights.

You’ll learn who the key authorities are in Europe and the U.S., how ICH-GCP serves as a global foundation, and how these guidelines influence not just what we write – but how we write it. With real-world examples and practical tips, she shows how regulatory context can clarify tricky phrasing, support your translation choices, and boost your confidence.

Whether you’re just entering the world of clinical trial content or looking to sharpen your skills, this session will help you understand the why behind the words -– so you can deliver translations that are accurate, compliant, and clear.

Speaker: Kathrin Kunze (Sweden)

Kathrin Kunze is a German medical translator and writer whose deep connection to medical language began at the age of six when she joined the Red Cross in Germany. Her passion for medicine led her to formal medical training at sixteen, followed by 14 years of hands-on experience in hospitals and private practices, further enriched by international work in Oceania and lots of additional education programs in various medical fields. Medical language is second nature to her, and she seamlessly blends her expertise with linguistic precision to help clients tailor their content for patients, investigators, and medical professionals. Now based in Sweden, she is one of the two founders of  MedTalks and writes a blog about her experiences in the ER, using her knowledge to bridge the gap between medicine and communication with clarity and accuracy.