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!
This seminar will address peculiarities in developing and submitting an eCTD within the ICH region as well as in worldwide eSubmisssion requirements.
This conference will help you overcome your labelling challenges and will address electronic formats, label change, the Falsified Medicines Directive and end-to-end labelling.
This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
This seminar provides you within-depth knowledge on marketing authorisation, CMC documents and GMP-requirements in Russia, Belarus, Kazakhstan and Ukraine.
- Frankfurt / 03. - 05.06.2019
This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.
- Berlin / 04. - 05.06.2019
This semiars informs you what to focus on to be well prepared for your next GCP audit in Biostatstics.
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 / 24. - 25.06.2019
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.
- Amsterdam / 26. - 27.06.2019