Results FOR "Pharma / Medical Devices"

HOT TOPICS Drug/Device Combination Products

This conference addresses the new regulatory framework for drug-device combination products. Use this opportunity to discuss the impact these changes will have on your products and how to implement the requirements.

Variations in Europe

Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.

eSubmission Manager in Europe

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.