Working with Countries that are Difficult to Budget and Negotiate - Alan Braverman January 10, 2012

1. Working with countries that
are difficult to negotiate
with
Points to Consider

2. Benefits
Potential Rapid enrollment
Cost
Treatment naïve patient population
Willing and eager investigators
Time

3. Risks
Language
IP/data rights
Subject Privacy
Regulatory Process
Insurance/Insurance requirements
Contract
Investigator Training

4. Risks-Budget
Cost of importation of study drug
Cost of comparator and other concomitant
medication
Other equipment requirements?

5. Other factors
Regulatory start-up times
Unstable political environments

6. Contact Information
Alan J Braverman, Pharm. D.
(215)-806-7793
ajbpharmd@verizon.net