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.
- Frankfurt / 17. - 18.02.2020
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.
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
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
The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.
- Frankfurt / Niederrad / 15. - 16.06.2020
This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.
- Berlin / 18. - 19.06.2020