I have learned more about the role of regulatory affairs and its different caveats, I am now also able to identify the different regulatory frameworks, authorities and pathways governing the marketing authorisations of different types of medicinal products. One of the most important points is the scientific background needed to understand if the data you are

Good background understanding of Regulatory Affairs in terms of how a drug access the market and which are the authorities involved. I am going to dig more into specific Regulatory affair roles. The course was well structured and our trainer was very well prepared. He interacted with us and answered all question with professionalism and efficiency.

Good understanding of computer system validation scope, purpose, principles, concrete system examples. What I will apply in the future is develop validation document (template in Excel with several tabs) for validation of program scripts. Great people, great environment, very dedicated trainer and team. Very applicable to my area in Clinical Operation (super specific to it).

I deeply understand the several job figures involved in the different steps of a clinical trail. This course also confirmed my choice in pursuing the career of CRA. I'll focus on completely understanding all the CRA's responsibilities and duties. The most positive experience was the kindness and professionalism of the trainer, who was always very willing

The workshop has been incredibly useful for understanding how to act, interpret, and detect errors in the documents. My objective was to obtain a full understanding of this role, an aim that this course was able to help me achieve. I am going to apply all my new knowledge during my upcoming internship, sharpening these skills

I got a detailed overview of the ISO 14155. Be vigilant during the trial and get thorough with the post-trial documentation. My most positive eperience was the ease with which the instructor has delivered the content and the way she took efforts to include DoH, ICH in this training. The course was designed to convey most

During this course, I learned how to act with clarity and assertiveness in specific and challenging situations. I also received valuable advice on how to effectively deal with different people — knowledge that will be extremely useful once fully developed. In the event that I encounter situations requiring the expertise I gained from this course, I

The training was very effective, good communication, gave me the skills to include the knowledge to my workday. Nice interaction with the trainer.

I wanted to know the difference in regulation between devices and drugs. This course gave me the basis to start working in medical devices, I feel confident to manage device studies now. It was a good group and the teacher picked in on each individual's background to ask questions.

I validated my basic knowledge on Regulatory Affairs and gained a few advanced knowledge. I'm considering studying more in this field. I enjoyed the interaction with trainer and other participants both during the course and after. The course provides some interesting basic knowledge, induces curiosity to learn more and allows the creation of new connections.