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This Short Course will be offered virtually – Join from anywhere!

This short course provides comprehensive training on ICH-driven extractables and leachables (E&L) harmonization initiatives transforming complex generic development. Participants master practical implementation of harmonized risk-based approaches and analytical standardization through interactive workshops.

Complex generic products including sophisticated inhalers, transdermal patches, and drug-device combinations present unique E&L challenges inadequately addressed by traditional guidance. Current ICH initiatives represent a paradigm shift toward unified global standards eliminating regulatory fragmentation.

The course examines active ICH working groups, draft guidance analysis, and implementation timelines through engaging multimedia presentations. Participants gain insights on agency negotiations and understand direct impacts on development strategies through interactive polling and breakout sessions.

Central programming features virtual hands-on application of emerging ICH risk-based assessment frameworks using digital case studies and collaborative online tools. Interactive breakout rooms demonstrate how harmonized approaches reduce development timelines while enhancing safety evaluation consistency.

Analytical method harmonization receives emphasis through virtual laboratory simulations. Participants explore standardized protocols, unified detection limits, and harmonized safety thresholds using interactive digital tools and real-time collaboration platforms.

Implementation strategies address organizational change management and regulatory submission optimization through virtual group exercises. Digital case studies highlight competitive advantages including reduced costs, accelerated timelines, and enhanced market access.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!