National dossier requirements and global life cycle management: How do they fit together? This course provides practical tips on how to professionalise your electronic dossier submission and life cycle management.
This course provides you with sound knowledge in dealing with the registration and distribution of medical devices in Russia, Belarus, Kazakhstan and many other countries.
- Frankfurt-Raunheim / 27.02.2020
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
Two experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes.
CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar
How to write the Module 3 for Regulatory Submission - Here you will get in-depth information.
Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.
- Amsterdam / Leiden / 02. - 03.04.2020
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
This biosimilars course addresses the available options for market access in the US and EU, including negotiating with the originator.