A UL EduNeering course
A pharmaceutical, biological, or medical product is generally not introduced into the marketplace unless it has been approved by a country’s regulatory agency. This basic course is designed to give an understanding of the approval process and the importance of developing products that meet regulatory requirements for global registrations. The safety and efficacy of products are approved via clinical trials in humans, by investigators who have demonstrated that the research was conducted under the auspices of good clinical practices (GCPs). The principles and applications of GCPs are essential in product development, and they are based on regulations, directives, and guidelines meeting global regulatory demands in the conduct of clinical research. All personnel involved in new product development—from bench scientists who discover the compounds or devices to researchers to marketing and sales personnel—should be aware of what is necessary to bring a new pharmaceutical or medical product to market.
- Regulations, directives, and guidelines that govern product development
- Phases of clinical research that follow GCPs
- Timelines and costs
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields