Working with Countries that are Difficult to Budget and Negotiate (Investigator Grants)Ying Jiang, TTCDr. Alan Braverman, Independent ConsultantDr. Mitchell Katz, PurdueDr. Peter Carberry, Astellas January 10, 2012 | Philadelphia, PA
Countries of Interest• Poland• Brazil• Russia• Argentina• China• India• Japan
Question #1• Do you budget centrally for your global investigator budgets?
Question #2• Do you negotiate all of the investigator agreements or do you outsource it to CROs?
Question #3• How do you budget for emerging countries or countries that you have less experience with?
Question #4• How do you gather market intelligence? Country specific requirements and etc. • Are you prepared for to pay for ancillary items such as concomitant meds or even things like IV tubing or IV bags which may be considered a ‘given’ here?
Question #5• How do you ensure FMV and ensure your budgets stay competitive? • Do you have benchmarks?
Question #6• Multiple parties agreements: how do you dealwith the timing of CTA vs MOH/Ethics • For example: Poland needs a fully executed CTA to accompany the submission.
Question #7• Timelines: do the lower per patient costsmake up for the extended start-up times insome of these countries?
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