Effective leadership by physicians in clinical research is a critical component of success in the overall outcome of new product development activities. Physicians represent the interests of biotech and pharmaceutical companies in protecting human subjects throughout trials and their decisions reflect the judgment and credibility of sponsor companies and ultimately the quality of the data. Physicians working in clinical research must ensure that studies meet regulatory standards and therefore must have an in-depth understanding of the principles of Good Clinical Practice (GCP). This course will cover the process of new product development, from bench to bedside, and will introduce the essentials of GCP. Embedded throughout the program are case studies to support GCP concepts for physicians conducting clinical research.
Physicians working in clinical research.
Advising: Current status of new product development
Overseeing: How the sponsor's responsibilities translate for the physician
Guiding: The physician as a medical expert and leader
The objectives of this course are to provide a detailed, physician focused, comprehensive overview of the principles of ICH/GCP, according to industry standards and FDA regulations. Physicians who attend will gain a better understanding of how they can support the team by providing medical guidance in line with sponsor policies and quality standards.
"This course provided a great overview and the right level of detail on all areas of vendor management.”