1. Discuss the importance of data recording and management in clinical research. What are some of the pros/cons of electronic data capture systems?
2. After reading the ICH E2D guidance, discuss the importance of pharmacovigilance in the life cycle management of medicinal products for human use
3. Pretend you are working for a pharmaceutical company with a drug that is about to finish Phase IIB clinical trials. This means it is time for your company to have potential meeting(s) with the FDA and you have been tasted of requesting such FDA meeting(s).
a) Summarize the different types of FDA regulatory meetings and discuss the meetings that you would request for further clinical development (i.e. Phase III trial) of the Company's investigational medicinal product.