Development of test method recommendations for regulatory consideration Sample Clauses

Development of test method recommendations for regulatory consideration. The objective is development when feasible of harmonized test method recommendations by each of the ICATM Validation Organizations that can then be forwarded to other national and international organizations for regulatory consideration. Key aspects include, when feasible: • Efforts by ICATM Validation Organizations to cooperate in the preparation of draft final recommendations, taking into consideration peer review panel report(s) and other relevant documents and information. • Sharing of draft final recommendations among the ICATM Validation Organizations to be considered along with the peer review panel report(s) and other supporting documents. • Notifying the other ICATM organizations of each ICATM Validation Organization’s draft position. In cases where all of the ICATM Validation Organizations mutually consent, each organization may finalize and forward their recommendations to their respective regulatory authorities to the extent authorized by applicable law. • Discussing unresolved disagreements to reach resolution among all of the ICATM Validation Organizations. If no resolution is reached within a reasonable timeframe, the scientific rationale for any disagreements may be documented and provided by the ICATM Validation Organizations to regulatory authorities with their respective recommendations, to the extent authorized by applicable law.
Sample 1
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