The Center for Professional Innovation & Education, Dublin, Ireland
September 24 & 25, 2009
Who Should Attend This two-day course is designed: - Device Manufacturers
- Device Sponsors and Management
- Clinical Laboratory Administrators, Directors, and Managers
- HealthCare Professionals
- CROs
- Project Managers
Learning Objectives
The objective of this course is to provide an overview of the preparation, design and management aspects of clinical trials for medical devices. Upon completion of this course, attendees will have an understanding of the unique challenges faced in clinical trials for medical devices, which will be useful in the future development of device technology. This course will review challenges, roles and responsibilities of sponsors and investigators during the clinical development phase. Participants will learn the essentials of coordinating, monitoring, and managing a clinical trial with an emphasis on good quality product outcome and meeting ICH E6 for Good Clinical Practice.
Course Description
Clinical trials design studies for medical devices are an integral part of the pre-market approval process. Keeping abreast of new scientific developments related to advances in applied clinical research is essential for successful product development. This course offers an opportunity for chemists, biologists, industrial engineers, and healthcare professionals to gain an in-depth understanding of the regulatory process for medical device applications, as well as, the global regulatory framework as it relates to the new medical device market.
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