Problem
Review the OHRP. Choose one country from the rest-of-the-world (ROW) (e.g. non-US/Non-European UnionLinks to an external site.) and review the Relevant Standards linked in the OHRP document for that country (hint: choose a country with hyperlinks to Relevant Standards imbedded in the OHRP compilation). After reviewing the OHRP Compilation and one ROW Relevant Standard, draft and post a DQ that addresses the following:
a) Summarize one Relevant Standard from a ROW country (non-US/non-EU).
b) Compare the ROW Relevant Standard to its closest EU/EMA counterpart (see, EMA Human RegulatoryLinks to an external site.), citing the specific EU/EMA standard.
c) Compare the ROW Relevant Standard to its closest FDA counterpart (see, FDA RegulatoryLinks to an external site.), citing the specific FDA standard.
d) Argue how the ROW Standard is superior and/or inferior to its EMA and/or FDA counterpart(s).