Kunika joined the RA STAR Programme in September 2023 in Brussels. The intensive week of classroom lectures exposed her to the latest in pharmaceutical regulations and clinical R&D, surrounded by like-minded peers and industry leaders. After the course, she began a one-year internship at Johnson & Johnson in Leiden as a Clinical Trial Application Submission Manager

What I found most helpful about the Regulatory affairs STAR Programme was its comprehensive approach, combining targeted training sessions with practical, hands-on experience. The programme is designed to equip participants with the knowledge, skills, and competencies needed for a specific job function in regulatory affairs. For me, the most valuable aspect was the opportunity to gain

My first internship was, for two months, as a study coordinator at UZ Gent. Here I learned about the role of a study coordinator within clinical research. Then I did an internship at Johnson&Johnson as a site manager, where I learned how clinical studies are monitored at the different sites. During this internship, I also experienced

The STAR Programme offered the combination of a week training and the opportunity to gain practical experience in different companies over a longer period, while being closely followed up by a mentor at ECCRT. It was reassuring and motivating to be followed up so closely by someone who genuinely cared about my progress. After completing my

I’m truly grateful to the entire ECCRT team for the opportunity to take part in the Junior Clinical Researcher STAR Programme. It was a valuable and enriching experience that has helped me build more confidence as I take steps forward in the clinical research field. I especially appreciated how practical and well-structured the content was.

I achieved the following objectives: understanding and application of risk-based approach, QbD / CtQ factors, fit-for-purpose processes and systems, computerized systems requirements - from both PI and sponsor perspectives. Very good answers to the questions, very interactive!

I improved my understanding of content and purpose of ICH GCP E6(R3), including deeper look into responsibilities of sponsor, investigator, IRBs, etc.; importance of data integrity and governance. For me, as a statistical programmer, this training expanded my understanding of the importance of data integrity. Even though this is a rather theoretical topic to me, the

I have gained a solid understanding of the principles and requirements of Good Clinical Practice. As a data manager I will apply ICH GCP principles by ensuring accurate and consistent data handling throughout the study lifecycle. The trainer was excellent - she had a great ability to make the rather dry and technical content of ICH

The course content was simplified and presented concisely using bullet points and animated diagrams, which made the learning experience highly engaging and enjoyable. The course content is rich and provides valuable insight into effectively using the terminology from ICH GCP E6 (R3) in your professional work and in communication with fellow clinical researchers.

My most positive experience was the clear explanations and practical examples that helped me understand the course content better. I would recommend ECCRT courses because they provide comprehensive and structured training on clinical research. The content is relevant and helps build essential knowledge.