A Kaplan EduNeering course

A drug, biologic or device product may not be introduced into commerce unless the regulatory agency of the country where it will be marketed has approved the product application for it.  The sponsor of the product must demonstrate by adequate scientific evidence that the product is safe and by substantial evidence that it is effective for the conditions prescribed, recommended, or suggested in the product’s proposed labeling.  The safety and efficacy of the product is approved via clinical trials in humans, by investigators that have demonstrated that the research was conducted under the auspices of Good Clinical Practices (GCPs).

The principles and applications of GCPs are essential in the process of new drug, biologic and device product development.  They are based on regulations, directives and guidelines meeting global regulatory demands in the conduct of clinical research.  The components of GCPs comprise ethical obligations of investigators, sponsors and monitors with the purpose of protecting human subjects’ rights.  However, all personnel involved in new product development, beginning with the “bench scientists” who discover the compounds or devices, every person involved in the research processes up to and including the marketing and sales personnel should be aware of what is necessary to bring a new pharmaceutical or device product to market.  This basic course is designed to give an understanding of the new drug, biologic and device approval process and the significance of how important it is to develop products that meet regulatory requirements for global registrations.

Topics include:
      ·          What drugs, biologics, and devices are
      ·          Regulations, directives, and guidelines that govern new product development
      ·          GCP
      ·          Technical documents required to gain approval to market new drugs, biologics, and devices
      ·          Phases of clinical research that follow GCP
      ·          Timelines and costs
      ·          Final stages in the clinical research process

Linda Belmont at DIA