I achieved a better understanding of the nuances of the GDPR and it's application to Clinical Research. I'm going to apply knowledge from the course to current internal projects requiring either consent or legitimate interest in regard to some of our data processing activities. I enjoyed the interactions with the instructor, especially the ones that occurred

Great discussion and interaction with trainer and attendees. ECCRT staff is very supportive and knowledgeable. They listen to your concerns and offer practical advices that are really helpful.

I am refreshed on the ICH GCP E6 and visualize the content of the R3. I will make sure to always think of the risks to participants and the data collection when I put in place the clinical processes and approaches in a study. It is a good thing to be refreshed on this important topic.

I achieved a better understanding of concepts related to clinical trials, GCP, data management, and regulatory requirements. My most positive experiences were 1. Gaining a deeper understanding of GCP principles and guidelines 2. Learning about regulatory compliance and ethical considerations 3. Applying GCP knowledge to real-world clinical trial scenarios

Very good refresh on GCP and new regulations. I am a program manager. This course will help me to better understand all the regulations around clinical trials and work more efficiently with the clinical team. Very nice overview and experience and knowledgeable trainer.

The content is usually broken down and explained well. Also, it was nice to bring everything into context at the beginning. The games were good for a fun review of the learned material.

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