Developing New Drugs

Unlock new job opportunities and advance your career in the pharmaceutical industry by gaining critical skills in regulatory affairs, drug development, and U.S. FDA processes.

This course provides in-depth knowledge of the Investigational New Drug (IND) application, U.S. FDA regulatory guidelines, non-clinical studies, and the complete process of bringing a drug to market. Whether you're a student, researcher, or working professional, this is your chance to upgrade your profile with job-ready skills in the high-demand regulatory field.

This course will give you insights on Investigational New Drug, IND Review, Basic for INDA, USFDA regulations, Nonclinical study overview, Updating INDA

Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

Drug development and approval process:

The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.

Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market. It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's NDA containing the data and proposed labeling.

What You’ll Learn

• The Drug Development Process from lab to market

Course Benefits

• Gain job-oriented skills in regulatory affairs

Course Format

• 100% online and self-paced

By the End of This Course, You Will:

• Understand how new drugs are developed and approved

Prerequisites: No prerequisites required, only need curiosity towards learning and science background.

Achivements after course:

1. Certificate of completion.