REGULATORY BOARD

Description:

The purpose of Regulatory Officer is to ensure the timely submission of a completed study dossier to the proper regulatory bodies and ensure that the expected timelines for regulatory approvals are met.

Responsibilities:

  • Tracking the progress of protocol versions, ensuring necessary translations are completed when a new version is released, and preparing study dossiers for submission to regulatory bodies.
  • They regularly follow up on the status of submissions, updating the CRS leader and coordinators, and ensure timely follow-up submissions for protocol amendments, serious adverse events, and annual progress reports to the IRB.
  • Ethics Committees and Review Boards

    De La Salle Health Sciences Institute Independent Ethics Committee


    Dr. Nikki Eileen Salvano-Valencia, Co-Chair


    De La Salle Health Sciences Institute

    Congressional Road, DasmariƱas City

    Cavite, 4114, Philippines


    E-mail Address: iec@dlshsi.edu.ph

    Contact Number: (+63) 46-4818000 local 8042

    Batangas Medical Center Research Ethics Review Committee


    Dr. Alfonso Syoei Yoshida, Chair


    Batangas Medical Center

    Bihi Road, Kumintang Ibaba

    Batangas, 4200, Philippines


    E-mail Address: rerc@batmc.doh.gov.ph

    Contact Number: (+63) 43-7061229

    Asian Hospital and Medical Center Research Ethics Committee


    Dr. Alfonso Syoei Yoshida, Chair


    Asian Hospital and Medical Center

    2205 Civic Drive, Filinvest Corporate City

    Alabang, Muntinlupa City, 1780 Philippines


    E-mail Address: bgco@asianhospital.com

    Contact Number: (+63) 2-87719000 local 8163

    Makati Medical Center Institutional Review Board


    Dr. Carolyn A. Butler, Chair


    Makati Medical Center

    7th Flr. Keyland Center, 143 Dela Rosa cor. Adelantado Sts.,

    Legaspi Village, Makati City, 1229, Philippines


    E-mail Address: irbmmc.admin@makatimed.net.ph

    Contact Number: (+63) 2-88888999 local 7166, 3972 or 3973