Ex-US Sites in A Multinational Study: Should They Be Included Under a US IND or Not?

Time

Wed, Jun 17 9:00AM
W 08

Title

Ex-US Sites in A Multinational Study: Should They Be Included Under a US IND or Not?

Abstract Summary

In the case of a multi-national study, a sponsor may choose, but is not required, to operate ex-US sites under an IND. The requirements for including or not including ex-US sites under an IND and the pros and cons of each approach will be discussed.

Poster Presenter

Jacqueline M. Kline
PhD,
Senior Director Global Regulatory Affairs,
Eisai Inc.
United States