Drugs and biologics go through a long and complex development process before being made available for treatment or prevention of disease. This process involves professionals from varied disciplines, such as scientists, clinicians, regulatory experts, legal experts and business specialists. Whether you are considering a career in pharmaceutical development or simply seeking a better understanding of the pharmaceuticals industry, this course will act as a primer.
Learn basic terminology as well as key regulatory principles and processes governing the lifecycle development stages of a pharmaceutical product––including early-stage research, nonclinical and clinical trials, manufacturing, marketing and postmarketing. Because the basic principles and regulatory steps for developing drug products are similar to those for biologics, this course highlights the differences between the two product types. Understanding the differences will help regulatory professionals develop better regulatory strategies for their products to move them through the regulatory pathways more quickly.
Learning Objectives
Upon completion of this course, participants should be able to:
- Define basic pharmaceutical terminology.
- Identify the key stages in the lifecycle of pharmaceutical products, including:
- Nonclinical development
- Regulation of clinical trials
- Safety issues
- Marketing approval applications
- Postmarketing activities
- Describe the general regulatory requirements relating to manufacturing (Good Manufacturing Practice) and marketing.
Target Audience
This course is intended for new regulatory professionals, as well as those in scientific, clinical, legal, and business who are looking to understand fundamental concepts in the pharmaceutical industry.