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!
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.
Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.