PPTA DHQ Implementation Workshop
June 14, 2010
Reston, VA
Plan to attend PPTA’s Donor History Questionnaire (PPTA DHQ) Implementation Workshop on Monday, June 14th in conjunction with the 2010 Plasma Protein Forum at the Hyatt Regency in Reston, VA. View the agenda.
After many years of work by PPTA staff and its Donor History Task Force, the U.S. Food and Drug Administration (FDA) advised PPTA that it had no more questions in its review of the PPTA DHQ in October 2009. The PPTA DHQ contains a full length and abbreviated standardized donor history questionnaires. These documents may be used by members to help streamline the donor screening process. Companies that wish to implement the PPTA DHQ before issuance of FDA final guidance may do so upon filing and approval of a Prior Approval Supplement (PAS).
In anticipation of final guidance, PPTA is holding a workshop that will cover an array topics related to the PPTA DHQ and its corresponding documents. The agenda will include information on the format of the PPTA DHQ and how to implement its use, including presenting it on an automated DHQ platform, PPTA’s role in maintaining the PPTA DHQ, and regulatory expectations.
Please contact Bridget Elis,
belis@pptaglobal.org for more information.
Seating is limited – Separate registration is required
(DHQ workshop is not included in the Forum Registration)
To register for this workshop, click here.