Regulatory Perspective on Drug Safety Assessment during Drug Development
- At: 2017 FIP Congress in Stockholm (Sweden)
- Type: Presentation
- By: SATO, Masanobu (Pharmaceuticals & Medical Devices Agency, Tokyo, Japan)
- Co-author(s): Masanobu Sato: Pharmaceuticals & Medical Devices Agency, Tokyo, Japan
One of the major concerns when conducting evaluation of a new drug at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is whether there are any unacceptable risks as compared to the benefit. A comprehensive evaluation on drug safety should be conducted considering whether the recognized risks in clinical studies can be controlled,.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.