Results FOR "Regulatory affairs & vigilance"

Global Regulatory Affairs Manager

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.

Development Expert Biologics

The Pharmacovigilance System Master File (PSMF) in a Global Environment

This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.

Scientific Writing and Reviewing in Regulatory Affairs

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.

eCTD Life Cycle Management - National and Global

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.

Medical Devices in Russia and the Eurasian Economic Union

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.

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.

Regulatory Affairs China

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.

ASEAN & Chinese CTD/eCTD

CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar

CMC Documents: Scientific writing for regulatory submission

How to write the Module 3 for Regulatory Submission - Here you will get in-depth information.