概要

This course will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development. During the course, we will discuss some of the challenges to conducting scientifically sound and ethical clinical trials and the continuing evolution of regulatory requirements.
Course Level: Beginner

何を学ぶか

How the pharmaceutical industry identifies new products and brings them to market
Contributions of key groups within the company and how they interact
FDA and regulation of the industry
Basics of filing a New Drug Application (NDA)
Ethical considerations in conducting clinical research
Concepts and functions associated with ensuring overall study quality

参加対象

This course is designed for those who are new, changing areas or roles in the pharmaceutical industry. Also professionals who work in the area of:

学習目的

At the conclusion of this activity, participants should be able to:

Recognize the process of discovering and developing new pharmaceutical products
Describe the activities associated with conducting clinical research and reporting the results and responsibilities of various departments in accomplishing these activities
Discuss institutional review, informed consent, and financial disclosure
Explain the concepts and functions associated with ensuring overall quality of studies
Describe the organization of the FDA, their authority, and interactions with sponsor companies

Overview of Drug Development

概要

何を学ぶか

参加対象

学習目的

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