Non-Clinical Studies for Implantable and Interventional Medical Devices - How to Get Started, What to Expect All Along the Way, and How to Avoid Disas

This webinar will equip you with knowledge on what type of studies need to be performed for implantable and interventional medical devices and what is involved all along the way. You will gain the knowledge necessary to bring your non-clinical project to successful completion.

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?

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.

Who Will Benefit:

• Project management
• Research and development
• Regulatory affairs
• Biostatistician