Walter Morris, PDA | Jan 03, 2017
Metrics Conference Offers First Chance to Hear from FDA
PDA is preparing comments on the U.S.
FDA’s recently revised draft guidance for industry:
Submission of Quality Metrics Data.
The revised draft was issued after strong
public interest and comment on the first
draft, which was published in 2015.
The 2017 PDA Pharmaceutical Quality
Metrics and Quality Culture Conference,
Feb. 21–22, in Bethesda, Md., will provide
industry representatives an opportunity to
interact with FDA officials involved with
developing the metrics guidance/program,
including the U.S. FDA’s Tara Gooen
Bizjak, Senior Science Policy Advisor
for Pharmaceutical Quality, CDER, the
contact person for the current draft.
“PDA is committed to providing sciencebased
commentary on the quality metrics
draft guidance, as we did with the release
of the first draft in 2015,” said Richard
Johnson, PDA President. “The quality
metrics/culture conference will be the fourth held by PDA on this important
topic since the FDA called for industry
participation in 2013.”
Learn more about the 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference!