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Reducing Drug Shortages
Session Chair(s)
Jeannie David, MS
Senior Program Management Officer, Drug Shortage Staff, CDER
FDA, United States
This session will discuss major quality challenges that may impact drug supply, Current Good Manufacturing Practice (cGMP) inspectional issues, and proactive/collaborative regulatory approaches with global health authorities to prevent, mitigate, and resolve drug shortages.
Learning Objective : Describe key considerations in high quality drug manufacturing and preventing shortage; Recognize industry efforts to mitigate or prevent shortages and the FDA's role; Identify how to interpret drug shortage information.
Speaker(s)
Inspections, Regulatory Compliance and Drug Shortages
Ramani Raghavan, MS, MSc
Genentech, A Member of the Roche Group, United States
Senior Regulatory Program Director
Preventing and Addressing Drug Shortages
Jeannie David, MS
FDA, United States
Senior Program Management Officer, Drug Shortage Staff, CDER
Shortages of Medicinal Products as a Result of Quality Defects or GMP Noncompliance
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
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Ways to register
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