Overview

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

What you will learn

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

Who should attend?

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:

Learning objectives

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

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Overview of Drug Development

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.