jun 5, 2018: 4:15 p.m. - 5:15 p.m.
Room 210A, Level 2
Thinking, worried, or confused about Expanded Access (aka compassionate use)? This session will answer your questions and ease your mind by starting with the ABCs (what does the law require you to do, and how do you do it? What resources exist?) and working through the XYZs (if you decide to provide expanded access to your investigational medicine, what are the things you need to think about, plan for, and do? what if you don't, provide expanded access? How do you move from decision to action in the most efficient and cost-effective way? What do "Right to Try" laws require of you?) The session will provide straightforward information, explanation, and tips to get you moving forward in whichever direction you choose and will provide resources you can use for dealing with specific situations. The session is intended primarily for small companies, and will cover both expanded access in the US and internationally. There will be 30 minutes set aside solely for question and answer from attendees.