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Informační listy
Fact sheets provide additional information about the global plasma protein therapeutics industry.
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PPTA Executive Summary of FDA’s U.S. Immunoglobulin Utilization Study Report
The CBER Surveillance Program BEST Initiative recently posted its Assessment of Immune Globulin Utilization in Commercially insured and Medicare Populations study report. The aim of the study is to provide a better picture of the evolution of Ig use over a 10-year longitudinal period in the context of emerging scientific evidence and clinical trends. PPTA developed an Executive Summary of the study report, highlighting key observations, findings, and conclusions.
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PPTA Statements
PPTA Executive Summary of FDA’s U.S. Immunoglobulin Utilization Study Report
The CBER Surveillance Program BEST Initiative recently posted its Assessment of Immune Globulin Utilization in Commercially insured and Medicare Populations study report. The aim of the study is to provide a better picture of the evolution of Ig use over a 10-year longitudinal period in the context of emerging scientific evidence and clinical trends. PPTA developed an Executive Summary of the study report, highlighting key observations, findings, and conclusions.
All
PPTA Statements
Quality Standards of Excellence, Assurance and Leadership (QSEAL)
"PPTA's voluntary standards program provides global leadership for the plasma protein industry's goal of continuous improvement with a focus on safety and quality from the donor to the patient. The standards program will be transparent, credible, innovative and responsive to stakeholder and industry needs." - Mission Statement, PPTA Voluntary Standards Program
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Safety and Quality
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Quality Standards of Excellence, Assurance and Leadership (QSEAL)
"PPTA's voluntary standards program provides global leadership for the plasma protein industry's goal of continuous improvement with a focus on safety and quality from the donor to the patient. The standards program will be transparent, credible, innovative and responsive to stakeholder and industry needs." - Mission Statement, PPTA Voluntary Standards Program
All
Safety and Quality
PPTA Statement on the Revision of the General EU Pharmaceutical Legislation
PPTA welcomes the revision of the EU pharmaceutical legislation as an opportunity to improve access to therapies, including life-saving plasma-derived medicinal products (PDMPs) for EU patients. A revised framework has the potential to provide a robust set of provisions that will continue to ensure the safety and quality of human plasma used for manufacturing, while upholding the safety, quality, and efficacy of PDMPs.
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PPTA Statements
PPTA Statement on the Revision of the General EU Pharmaceutical Legislation
PPTA welcomes the revision of the EU pharmaceutical legislation as an opportunity to improve access to therapies, including life-saving plasma-derived medicinal products (PDMPs) for EU patients. A revised framework has the potential to provide a robust set of provisions that will continue to ensure the safety and quality of human plasma used for manufacturing, while upholding the safety, quality, and efficacy of PDMPs.
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PPTA Statements
Qualified Donor Standard
Facts about Qualified Donor Standard.
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Fact Sheets
https://cdn.prod.website-files.com/638f893112c6eac0e46ac576/64529e2c6723641942df9fc1_PPTA_Qualified_Donor_FACT_Sheet_v2.pdf
Qualified Donor Standard
Facts about Qualified Donor Standard.
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Fact Sheets
https://cdn.prod.website-files.com/638f893112c6eac0e46ac576/64529e2c6723641942df9fc1_PPTA_Qualified_Donor_FACT_Sheet_v2.pdf
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