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2015 GAMP® 5 Training
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Pharmaceutical Glossary

Amino Group
The –NH2 group. Amino groups are weakly basic and are found in organic molecules. Important for ...

ISPE Initiatives

Quality Metrics
ISPE is leading the charge to bring industry and regulators together for open dialog and exchange.

Drug Shortages
ISPE’s Drug Shortage Initiative facilitates communication between the pharmaceutical industry and global health authorities to understand and address this complex problem.

Blend and Content Uniformity
An ISPE-sponsored group of regulators, industry, and academia are identifying alternative approaches to assess Blend and Content Uniformity.

Patient Initiative: Survey on Patient Experience with Clinical Trial Materials
A global survey on patient experiences with clinical trial materials, including the suitability of packaging, labels, technologies, transportation, and storage.

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Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework
by Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore, and Evdokia Korakianiti

Starting Materials Selection and Life Cycle Management
by Richard Andrews, Mike James, Luc Janssens, Paul Marshall, Frank Montgomery, and Ron Ogilvie

Establishing and Managing Processes Enabling Delivery and Returns of Investigational Medicinal Products (IMPs) to Patient’s Homes
by Massimo Eli, Catherine Hall, Marianne Oth, PhD, Adrian Peskett, and Esther Sadler-Williams

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Dust Regs
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