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.
This advanced seminar is designed as an advanced course and will focus on all relevant topics for an expert in the field of medical scientific information. Our speakers will update you on all the applicable key issues.
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!