Romina Kardashi
I enjoyed the course in total. The interaction bits were very good. The course was well constructed, clear points, optimally conveyed concepts, good graphics and interaction. Keep up the good work. Thank you!
Aishee De
The course offered a comprehensive overview of clinical research, covering history, the clinical trial lifecycle, the evolution of guidelines and legislation, inspections, compliance requirements, and their implications. I learned a great deal and enjoyed the whole learning experience. The course covers all the basics in simple, easy-to-understand terms, emphasizing important points. Although it has a lot
Mary Ann Njoki Wairua
Thanks to the training, I can now, explain regulatory affairs and its different areas of activities, explain authorisation pathways, identify key players and their roles & learn trends in regulatory. I will be kick starting my Regulatory Affairs internship in 2 weeks and I will apply everything I learnt today in my internship. I appreciated how
Aishee De
I have gained a comprehensive knowledge of regulatory affairs, including its origins, relevant legislation, authorization procedures, as well as key concepts and practical applications. As a next step, I will definitely apply my understanding of authorization procedures in practice by critically analysing regulatory requirements for specific products and aligning them with compliance standards. This will be
Claudia Del Amo
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
Andrea D’Amico
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.
Artem Gubanov
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).
Nicolò Mattei
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
Nicolò Mattei
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
Anonymous
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
