What Are the Attributes That Companies Believe Would Help Agencies to Make Quality Regulatory Review Decisions?

Time

Tue, Jun 25 11:45AM
T 14

Title

What Are the Attributes That Companies Believe Would Help Agencies to Make Quality Regulatory Review Decisions?

Abstract Summary

We surveyed global pharma companies involved in the EMs to identify attributes they felt enable regulatory review in terms of timeliness, predictability, transparency, and quality and to rate regulatory agencies for these attributes. Results from the 9 responding companies are presented.

Poster Presenter

Lawrence Liberti
MS, RPh, RAC,
Executive Director,
Centre For Innovation In Regulatory Science (CIRS)
United States

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