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Standardized Data for PQ/CMC Public Meeting

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FDA White Oak Campus

10903 New Hampshire Avenue

Bldg. 31 Conference Center

Silver Spring, MD 20993

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC).” This public meeting is intended to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the 2017 Federal Register notice (FRN), “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies.” FDA will use the information from the public meeting to improve the usability of the proposed data standards.

DATES: The public meeting will be held on October 19, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments on this public meeting by November 16, 2018.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Bryan Spells, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, Bryan.Spells@fda.hhs.gov, 240-402-6511; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Norman Gregory, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., HFV-143, Rockville, MD 20855, Norman.Gregory@fda.hhs.gov, 240-402-0684; or Michael Kerrigan, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., HFV-143, Rockville, MD 20855, 240-402-0644, Michael.Kerrigan@fda.hhs.gov. Alternatively, send questions to the PQ-CMC mailbox: PQ-CMC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

PQ/CMC is a term used to describe manufacturing and quality control information submitted to FDA in support of submissions. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. This information is primarily submitted in Module 3 of the Electronic Common Technical Document. The standardization of PQ/CMC data elements and terminologies will facilitate the Agency’s transition to a streamlined electronic review environment.

FDA intends to identify and standardize data elements and terminologies for information commonly used and submitted in support of drug product applications. The impetus for this standardization effort was the provisions from the Food and Drug Administration Safety and Innovation Act of 2012 (21 U.S.C. 301 note) (Pub. L. 112-144), which authorized the Agency to require certain submissions to be submitted in a specified electronic format. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a consistent look and feel for every application, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating standardized data dictionaries.

As part of this effort, in 2017, the FDA released a Federal Register notice presenting a “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies” for public comment (https://www.federalregister.gov/a/2017-14456). FDA has subsequently utilized the comments received to revise and improve the data elements, terminologies, and definitions for PQ/CMC standardization. FDA intends to continue public engagement regarding PQ/CMC data standards development by holding the public meeting announced in this notice. After the public meeting, the Agency intends to issue a draft guidance on the standardization of PQ/CMC data elements and terminologies for electronic submissions.

II. Purpose of the Public Meeting

The purpose of the October 19, 2018, public meeting is to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the Federal Register notice, “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies,” released in 2017 for public comment (https://www.federalregister.gov/a/2017-14456). FDA will use the information from the public meeting to improve the usability of the proposed data standards. The public meeting will focus on the current state of PQ/CMC standardization and its future development, to which the output and comments from this meeting will contribute. Topics of discussion may include:

  • Ongoing development of PQ/CMC data elements and terminologies, including revisions informed by public response to the “Draft Standardization” Federal Register notice, developing the technical specifications for PQ/CMC data submissions, and upcoming development and testing of PQ/CMC data exchange mechanisms.

  • Ongoing efforts to maximize harmonization of PQ/CMC standardization with other national and international data standardization activities sharing the same domain space as PQ/CMC (e.g., International Organization for Standardization Identification of Medicinal Products (ISO IDMP) standards development, the European Medicines Agency’s Substance, Product, Organisation and Referential (SPOR) Master Data initiative).

  • An understanding of industry business practices regarding submission of PQ/CMC data which will help to inform development of PQ/CMC standardization.

III. Participating in the Public Meeting

Registration: To register to attend “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control; Public Meeting” please register at: https://www.eventbrite.com/e/standardized-data-for-pqcmc-public-meeting-registration-47224509780 by September 21, 2018. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by September 21, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

If you need special accommodations due to a disability, please contact Bryan Spells, 240-402-6511, email Bryan.Spells@fda.hhs.gov at least 7 days before the meeting.

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FDA White Oak Campus

10903 New Hampshire Avenue

Bldg. 31 Conference Center

Silver Spring, MD 20993

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