Results FOR "Pharma / Medical Devices"

EU Regulatory Affairs Introductory Training Course

Do you need essential European regulatory affairs knowledge? This course gives you a compact overview about all important issues. Each day may be booked separately according to your needs!

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.