This online training addresses the needs of regulatory affairs managers dealing with marketing authorisations outside the EU or planning to do so in the future.
This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.
After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with
a greater awareness of the importance of proper English writing, reviewing and proofreading processes.
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.
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.
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.