Going to BRIC Countries can be scary, especially if this is your first time. What are some factors or advice?


L. Koelle – Have local people with strong knowledge work with you. Whether it is an affiliate of your company or a CRO, having contacts at the agencies working with you is best. Having a partner, like a CRO from the very beginning, to obtain importation licenses and having a submission strategy is best.
For example, new regulations were reached in Argentina that contracts need to be signed before they reach the ethics committee. Having regional and country specific knowledge will best resolve the issues that arise.

J. Zimmerman – Fear of the unknown is the biggest factor from a clinical operational management perspective. Having a large multi-national CRO partner, especially for a small biotech company, is best. BUT, do not go where the CRO does not have staff.

A. Lyubchenko – Having a CRO with a local staff for regulatory connections will make it easiest for you. “Think Globally; Act Locally.” Big Pharma, like J&J, has local people in all BRIC countries, and they guide us through the process. They know the best.