Speaker:
Bruce Schechter

Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.

Learning Objectives:

At the end of this webinar the participant will be able to:

• List the differences between an early access program and a clinical trial
• Compare the different types of early access programs
• Describe the components needed to implement an early access program
• Understand how local laws and regulations govern the conduct of an early access program
• Understand the benefits and drawbacks of conducting an early access program