Non-Clinical Studies for Implantable and Interventional Medical Devices

Why Should You Attend:

If you are unsure of the answers to more than a few of the following questions, then you really need to attend this seminar.

• How many studies need to be done?
• Should they be acute, chronic, non-GLP, GLP?
• Should we go to a university or could that be very bad?
• What makes a “good” laboratory, one worthy of sending our study there?
• What animal models should be used and which should not?
• How many animals will need to be used per study, and how is that figured out?
• What role, if any, should the U.S. FDA have in our study design?
• What are the regulations associated with animal research?
• What work do we need to do to get a protocol approved?
• What goes into a protocol?
• What is an animal use form?
• What is an IACUC, who is on it, and what is our involvement?
• How fast can my study design be approved and when can the study start?
• Who performs the study, and what is our company's involvement?
• Who should be involved with communications between our company and the laboratory and why?
• What do we receive from the laboratory in return for payments to them?  What can be expected in the way of charges for their work?

Areas Covered in the Seminar:

• Purpose and types of a non-clinical study.
• Choosing a contact research or university laboratory.
• The relationships between your company and the laboratory.
• Key players involved in a study.
• Role of the study director, laboratory management, and quality assurance.
• Activities that are common to most studies.
• Costs.
• Protocols and the institutional animal care and use committee.
• The conduct of the study.
• What can go wrong and what you need to do to avoid these.