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
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.
- Frankfurt / 18. - 19.06.2020
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!
Our experts will update you every month with the latest updates and trends in clinical studies. Thus, you will always have essential information on the design and conduct of clinical trials, as well as practical tips for successful collaboration at the interfaces to other areas.
This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.
- Online /
- Online / 31.12.2019