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Chapter Overview
This chapter discusses recent trends in regulatory guidance. The rules and guidelines have developed over time due to new threats or requirements. For example, the need for a robust mechanism for consumers and patients to trust their medicines' authenticity led to the DSCSA and the falsified medicines directive.
Course content
GMP Refresher Course 2023
Section Overview Free
Changes to Veterinary Regulations
Changes to Clinical Trials Regulations
CDER Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
Risk Management Plans to Mitigate the Potential for Drug Shortages
Non-Penicillin Beta-Lactam Drugs- A cGMP Framework for Preventing Cross-Contamination
Update to EU-GMP Annexes
Chapter Summary
Quiz