(Revised)

Public Meeting

Request for Quality Metrics

Docket Number FDA-2015-D-2537

August 24, 2015

FDA White Oak Campus
10903 New Hampshire Ave.
Bldg. 31, Rm. 1503
Silver Spring, MD 20993

Agenda

Following each presentation, FDA panel members will have a brief opportunity to ask clarifying questions.

8:00 - 8:30 am Registration

8:30 8:40 am Moderator Remarks

Brian Hasselbalch, Acting Deputy Director, Office of Policy for Pharmaceutical Quality (OPPQ),
Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER)

8:40 8:55 am Introductory Remarks

Janet Woodcock, Director, CDER and Acting Director, OPQ

8:55 9:05 am Opening Remarks

Ashley Boam, Acting Director, OPPQ, OPQ, CDER

9:05 9:15 am Technical Specifications

Ron Fitzmartin, Senior Advisor, Office of Strategic Program (OSP), CDER

9:20 9:30 am
Diane Hagerty, International Society for Pharmaceutical Engineering (ISPE)

9:35 9:45 am
John Punzi, Consumer Healthcare Products Association (CHPA)

9:50 10:00 am
Richard Johnson, Parenteral Drug Association (PDA)

10:05 10:20 am Break

10:25 10:35 am
Camille Jackson, Pharmaceutical Research and Manufacturers of America (PhRMA)

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10:40 10:50 am
David Gaugh, Generic Pharmaceutical Association (GPhA)

10:55 11:05 am
Priscilla Zawislak, International Pharmaceutical Excipients Council (IPEC) of the Americas

11:10 11:20 am
Alan Nicholls, CopperHead Chemical Company

11:30 12:00 am Open Public Comment

12:00 12:15 pm Closing Remarks and Adjournment

Russell Wesdyk, Acting Director, Office of Surveillance (OS), OPQ, CDER

The meeting page link on the FDA website is http://www.fda.gov/Drugs/NewsEvents/ucm456083.htm and all
documents and related information are available on this page. Please be advised that as soon as the transcript
and the recordings of the meeting are available, they will be accessible at this link.

A live webcast of this meeting will be viewable at https://collaboration.fda.gov/qmpm2015/on the day of the
meeting.

Written and electronic comments will be accepted after the hearing until September 28, 2015, Docket Number
FDA-2015-D-2537. Submit written comments to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Room 1051, Rockville, MD 20852. Submit electronic comments to
http://www.regulations.gov.

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