Regulatory Affair-Drug Development (INDA) Certificate Course

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

• Investigational New Drug (IND) application & review procedures

• Basics of INDA (Investigational New Drug Application)

• Overview of non-clinical (preclinical) studies

• Key USFDA regulations you must know

• How CDER (Center for Drug Evaluation and Research) evaluates drug safety and efficacy

Course Benefits

• Gain job-oriented skills in regulatory affairs

• Improve chances of selection in pharma interviews

• Add a valuable skill to your professional resume

• Stay updated with the latest developments in drug regulations

• Learn directly applicable knowledge for roles in FDA submissions and approvals

Course Format

• 100% online and self-paced

• No prerequisites required – just curiosity and a background in science or healthcare

• Certificate of Completion provided

• Lifetime access to course content

By the End of This Course, You Will:

• Understand how new drugs are developed and approved

• Be familiar with the regulatory frameworks of the U.S. FDA

• Be ready to apply for roles in research and regulatory departments

• Enhance your profile with in-demand pharmaceutical skills

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

Achivements after course:

1. Certificate of completion.

2. Add on skill.

3. You can update your professional profile.

4. New job opportunities in research.

5. Life time access to course.

6. Upgrade your skills and knowledge in clinical research.