Clinical Trial Design For Medical Devices 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. View Course Agenda Past Participants' Comments: "The course was fantastic.  It was the best medical device course I have attended." David H., Clinical Trials Coordinator, Cook Biotech Inc. "The Course Director was very knowledgeable.  He accommodated all of our questions and also made himself available during breaks and after class for questions." Denese S., Clinical Research Associate, Covidien “The course was very informative.  The Course Director was well informed and conveyed a wealth of experience in the practical application of course material." Alastair R., Doctor, D3 Technologies "This course was very beneficial and went into more detail that I expected.  The real life examples were great.  The instructor did a nice job of keeping the class engaged and attentive.  This was a useful course and I would recommend it." Jennie R., Clinical Research Associate, Ocular Therapeutics Please Select a Location / Date Before clicking on the Register Button: The Hilton Hotel, Orange County/Costa Mesa, CA -- Dec. 02 & 03, 2010 -- $1950.00

Certification Programs available for this Course: Clinical Compliance Certified Professional (CCCP)

Certified Medical Device Compliance Professional (CMDCP)

Related Courses: Adverse Drug Events – Reporting & Regulatory Requirements

Good Monitoring Practices for Medical Devices

The EU Clinical Trial Directive

Good Clinical Practices (GCPs)

How to Monitor Clinical Trials for GCP Compliance

Project Management for Phase 1 & 2 Clinical Trials

Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process