Seminare zu Pharma / Medical Devices
Pharma / Medical Devices

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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!

  • Amsterdam / 25. - 27.11.2019

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.

  • Amsterdam / Leiden / 02. - 03.03.2020

Variations in Europe

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

  • Amsterdam / Leiden / 02. - 03.04.2020

eSubmission Manager in Europe

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

  • Amsterdam / 18. - 19.05.2020
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