New Drug Development Process
12 Contact Hours - 3 Days
Overview This training will provide the attendees with a fundamental knowledge of drug discovery and development process from both a preclinical and clinical perspective. This includes approaches to sourcing and developing new drugs, from natural sources to rational drug design, as well as approaches to testing drug efficacy and safety in both preclinical phases and in clinical trials.
Objectives
Objectives
At the end of the training, participants will:
- Learn the different stages of clinical development as well as the regulatory process including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling
- Learn how to incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas
- Learn the product registration and approval process after a drug is considered safe and effective