Online CourseOnline Course Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective

Pharmaceuticals: Definition & Lifecycle [1.0 RAC]

1.0 RAC Credits Member: $135.00 Nonmember: $185.00
Pharmaceuticals: Definition & Lifecycle [1.0 RAC]
Drugs and biologics go through a long and complex process of development before being made available for the treatment or prevention of diseases. This process involves a wide range of experts, including chemists, pharmacists, medical doctors and clinicians as well as professionals in areas such as regulatory affairs, legal and marketing. Whether you are considering a career in one of the many functional areas involved in pharmaceutical development, or simply seeking a better understanding of the pharmaceutical business, this course will provide an introduction to the pharmaceutical industry, the drug development process, and regulatory requirements governing the pharmaceutical industry.

This course also provides an introduction to the lifecycle of drug products, from discovery to on-market support. You will learn the basic terminology used in the pharmaceutical industry as well as key regulatory principles and processes governing the stages in the development of a pharmaceutical product. Stages covered will include discovery of a new molecule, nonclinical and clinical trials, manufacturing and formulation development, regulatory approval and on-market support.

At a Glance
  • Target Audience: This course is intended for new regulatory professionals, as well as those in scientific, clinical, legal and business fields who are looking to understand fundamental concepts in the pharmaceutical industry.
  • Learning Level: Basic
  • Total Length of Course: 1 Hours
  • RAC Points: 1

Learning Objectives

Upon completion of this course, participants should be able to:
  • Define basic pharmaceutical terminology
  • Identify the key stages in the pharmaceutical product lifecycle, including
    • nonclinical development
    • regulation of clinical trials
    • safety issues
    • marketing approval applications
    • postmarketing activities
  • Describe the general regulatory requirements relating to good manufacturing practice and marketing

Lesson Titles
  • Lesson 1: Definition and History
  • Lesson 2: Product Lifecycle
  • Lesson 3: Regulatory Requirements

Enrollment Period: 12 months
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