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Regulatory issues in Latin America

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Regulatory issues in Latin America

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    1. Max S. Mano Assist. Prof. Medical Oncology University of So Paulo (USP/ICESP) Medical Oncology Hospital Srio Libans Regulatory issues in Latin America

    2. Saturation of clinical trials sites

    6. Brazil peculiarities Directives 196/96, 251/87, 292/99 and Resolution 404

    9. Brazil - peculiarities Use of placebo, post trial access to treatments Resolution 404, August 2008 Reaction to the 2008 Declaration of Helsinki, especially against 2 clarifications notes (on the use of placebo and post trial access to treatments) These clarifications are not acceptable and for the Brazilian regulatory process the content of the 2000 version of the Declaration of Helsinki was retained In other words: At the end of the study, all patients should be given acess to the treatments that have been proven effective (by the study sponsor) No placebo except in situations where no effective therapy exists

    10. Complex regulatory process

    11. 2005

    12. Main site selection criteria by investigators

    13. Regulatory Flowchart Brazil Long time to dossier preparation Unnecessary double (and sequential!) process of EC approcal (local central EC) Agencies inefficient in protocol turnaround times Import process inefficientLong time to dossier preparation Unnecessary double (and sequential!) process of EC approcal (local central EC) Agencies inefficient in protocol turnaround times Import process inefficient

    14. Regulatory Flowchart Chile Ethics cleared at site (or regional) level Central agency relatively efficient Relatively straightforward processEthics cleared at site (or regional) level Central agency relatively efficient Relatively straightforward process

    15. Regulatory Flowchart Mexico From site approvals (EC) to central agencies no paralel processes Central agency efficient Licenses released fastFrom site approvals (EC) to central agencies no paralel processes Central agency efficient Licenses released fast

    16. Brazil recent changes Resolution 39 (05 jul 2008) National Ethics Committee (CONEP) and ANVISA (FDA-equivalent) a truly parallel process (potential savings 6-8 weeks for the coordinator site) ANVISA can approve all study sites in one submission (potential savings of up to 6 weeks for subsequent sites) Doubful if these agencies will have sufficient staff to cope with these timelines

    17. Summary of Effects of Regulatory Changes in a Growing LatAm Region

    18. Latin America regulatory processes In Latin America in general, the review process is sequential: first EC and then MoH. In the USA, each trial requires IND submission to the FDA and in parallel an IRB approval. The rate limiting step is mainly the IRB submissions and approvals process. In EU, there is a parallel review process, and so submissions to ECs and Competent Authority (MoH) can be performed simultaneously (i.e: in parallel.)

    19. Challenges and opportunities

    20. Regulatory timelines in Brazil

    24. Brazil proposals Under discussion: Regional ECs (CONEP should only arbitrate and advise/control ECs) Doubful if there will be enough qualified staff willing to cope with the review process Under implementation: Fully paper-free dossier (on line submission)

    25. Protocol issues identified by CONEP

    26. Academic (Institutional, Non Sponsored) Research No specific legislation for academic research All CNS directives/resolutions apply Difficult to obtain trial insurance in Brazil (probably in L.A. In general) Non insured research may be dangerous for institutions and investigators, especially as no sponsor can be identified

    27. Academic (Institutional, Non Sponsored) Research The National Health System (SUS) does not cover hospitalizations related to side effects Probably the most limiting aspect of academic clinical research in Brazil

    28. Pharmaceutical companies # Thinking of bringing trials to LA? Crucial steps: Early planning Select CRO based at and with a good track of experience in the region With native professionals, familiar with local culture and language, regularions etc Good site selection (eg experienced coordinating site in Brazil makes a major difference)

    29. Conclusions Our regulatory process as a whole can become more efficient Our experience with clinical trials is less than 15 years old and there is goodwill from all parts (academic centres, investigators, regulators and industry representatives) to make continuous improvement

    30. BACKUP

    31. Brazil peculiarities RESOLUTION CNS N 251/97 I.4 In any clinical trial and in particularly when potential conflicts of interest with novel compounds may apply, the dignity and well-being of the study subject must prevail over all other interests, whether financial, scientific of communitary.

    32. Countries main agencies

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