** Permanently Retired Due to Lack of Enrollment **

The prevention of drug shortages is critically important to public health. As a not-for-profit global organization with both industry and regulatory members in 90 countries, ISPE is uniquely positioned to facilitate communication between the different sectors of the pharmaceutical industry and global health authorities as it seeks to understand and address this complex problem.

The ISPE Drug Shortages Team focuses on the technical, scientific, manufacturing, quality and compliance issues associated with a company’s supply chain and related to its ability to source, manufacture and distribute products that have resulted in drug shortages.

For example,

• Insufficient manufacturing capacity, exacerbated by industry consolidation, leading to fewer firms making a product.
• Product quality issues that result in temporary or permanent halting of production
• Lack of secure, consistent availability of active ingredients, components, containers, or closures of suitable quality, even reagents for quality control tests, which can be exacerbated by the increasing globalization of the supply chain for ingredients and manufacturing
• Shifts in demand that arise from shortages of another drug – causing a chain reaction of shortages
• Unexpected market outcomes from new approvals e.g. generic manufacturing capacity does not meet expectations, manufacturer of newly approved entity does not have sufficient capacity to meet market demands.

This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

Approximate Course Duration: 60 minutes (this is a self-paced course)

*NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements