Good introduction for people new in this field - received lots of good advice for future conduct of Audits and Audit Report writing, as well as helpful advice on how to prepare for Audits - very satisfied - I would like to thank the Trainer for this great course and hope to see her in future

The training helped me bridge the gap between the theory of the law and its practical application in our business.

Before going to this course "CSV" was a dark bow for me. So with this training and also with the expertise of our trainer, I'm able to understand almost every thing when people are talking about computer system validation - The training was very interesting thanks to Marc. With his expertise, he explains us the trick

I had previously worked in a GCP environment, but for some years wasn't active in this field. I now feel more secure and comfortable with the upcoming tasks at Takeda - I really liked the interactive sessions with the questions

It is a good overview on the preclinical study required to enter phase I. Comprehensive overview on CMC and toxicology studies.

I learned the concept regarding how to set the starting and miximum doses and how to design the dose escalation. The CMC and preclinical requirement, the design of FIH protocol, determination the dose range for FIH clinical trials. 

It is a well organised course in which all the aspects important for a junior CRA will be explained. Since I am working in the Academic, I thought it was really nice to get more insight in how things are be done in the companies. It was really good, it was a small group of people (6) so

I enjoyed the interactivity between participants and practical issues that happens in the field - complete, intense, practical, useful.

Everything I learned in this course will be taking into account regarding my work with clinical trials - Teacher is excellent and course content is very useful for all those who deal with Clinical Trials - Great teacher keeps students motivated and allowed questions and analysis of real day by day examples

Good trainer who applies training material into practice which is applicable for our organization (real life examples) - Marleen took time to discuss items which were not clear for us and she used examples from our type of studies to explain the study material.