What you will learn
- The basic principles of clinical drug development
- Study designs and different phases of drug development (Pre-clinical, Phase I, II & III studies, post-marketing studies)
- The importance of pharmacovigilance during study conduct and post-marketing
- The importance of data monitoring during clinical trials according to ICH Good Clinical Practice (GCP)
- The regulatory requirements in the drug development life cycle and market authorization process
What your company will get
- An employee who understands the basic principles of clinical drug development
- An employee who understands the importance of data monitoring and data safety (pharmacovigilance)
- An employee who understands the regulatory requirements during drug development and the market authorization process
- An employee who can provide valuable input to all other team members involved in clinical drug development