Clinical Trials: Comparative Study Of Guidelines In Europe and India

ISBN-13: 9783330346765 / Angielski / Miękka / 2017 / 96 str.

Vijay Kumar

Opis

This book is based on Clinical Trial Regulation in Europe and India. Comparison is done on the basis of different parameters such as regulatory bodies involved, regulations for CTs, clinical trial application format, application fee, approval time, the various forms required, role and responsibilities of IRB/IEC, record retention time, and GCP guidelines. The success rate of CTs in Europe is higher in comparison to India, which may be due to well-trained investigators, fast regulatory approval process and volunteer participation by the subjects.

O autorze

Master of Pharmacy in Regulatory Affairs from Lovely Professional University. I thankful to my parents who taught me the real meaning of Life. My Father is my Inspiration who always gave me positivity. Love my Parents and feeling blessed I have these Person in my Life.