Seminar on Medical Device Good Clinical Practices and Monitoring

Category: General > Education 12th Jan 2012 - 13th Jan 2012 , 09:00 AM - 04:00 PM

This seminar was designed for those who desire an overview of the device approval process, the regulations that govern IDE studies, the CRA's role in monitoring, and the FDA's role in auditing. It includes a review and discussion on recent monitoring and research site warning letters. It consists of a comprehensive review of the GCP obligations of the sponsor and the investigator, the FDA Guidance: Investigator Supervisory Role, the regulations that protect the rights and safety of human subjects. A glance at the similarities and differences between the FDA regulations and the ICH GCP (E6) guideline, and a review of some key safety definitions from ISO 14155-1:2003. It also reviews the key documents and elements of the clinical investigation at the site level, including the Investigator Study File and the Sponsor's Trial Master file, as well as all the report requirements and the reporting timeframes. Informed Consent and AE Exercises are performed to enhance learning. MRM provides each participant with a CD-ROM Regulatory Reference.

Objectives:

- List the sponsor's, investigator's and IRB's responsibilities in medical device studies.

- Discuss the monitoring activities performed for an investigational device study.

- Identify adverse device effects and their reporting
requirements.

- Discuss the differences between the IDE Application versus the 510K and the PMA.

- Recognize the purpose of the FDA BIMO Inspection program.

Upcoming Dates:
March 22-23, 2012
July 19-20, 2012
October 18-19, 2012

Who Should Attend:

CRA's and other Device Industry professionals who want to gain knowledge about the device approval process, GCP governing IDE studies, and the monitoring role.