Learning Objectives

The objectives of this course are to provide an overview for good monitoring practices for medical device firms and clinical research organizations, specifically for the essential experimental design and management aspects of clinical trials.  Upon completion of this course, attendees will have a clear understanding of global regulatory requirements and will have gained the knowledge necessary to effectively plan, validate, and monitor medical device-related development programs.  Participants will have an understanding of the investigator’s roles and responsibilities in all clinical developmental phases.  This course will address some of the global challenges of developing device trial studies.  Additionally, the course will also address the advantages/disadvantages of CRO hosted trials in keeping track of monitoring activities and study closeouts.  Participants will learn the essentials of coordinating, monitoring, and managing a clinical trial with an emphasis on a good clinical outcome.

Course Description

Good monitoring practices for medical devices are an integral part of product development.  Keeping abreast of new scientific knowledge and global regulatory procedures related to advances in applied clinical research is essential to the success of  the medical device industry.  This course offers an opportunity for clinical researchers, industrial engineers, and healthcare professionals to gain an in-depth understanding of the regulatory process in medical device applications, as well as, the global regulatory framework as it relates to their product’s technology and market.  This course provides comprehensive, up-to-date knowledge of regulatory processes contained in U.S. and international regulations, standards, and guidelines.  The guidelines of the International Conference on Harmonization (ICH) will receive special attention throughout the course.  The course will also prepare attendees to plan and execute effective and compliant method validation plans.

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