When you are working in Regulatory, you know the complexity of a time-critical publishing project very well. In this webinar, we would like to show you an example of a difficult Publishing Services project, which we performed for our customer argenx. It was a rolling BLA submission and could be finalized punctual despite a lot of challenges. The speakers will show how they managed to make this project successful.
Christina Stavrinidis (Manager Publishing Services, EXTEDO) will introduce you to our services offering and explain the project which we have performed for argenx.
Kristien van Nimmen (Senior Manager Regulatory Affairs, argenx) will tell you the difficulties which appeared and how this submission could be published in time anyway.
After this customer case story, Anjana Pindoria (Director Product Strategy, EXTEDO) will show you, how the submission could be reviewed in eSUBmanager before it had been submitted to the FDA. At the end, the speakers will answer your questions in a Q& A session.
- Introduction of EXTEDO's Regulatory Publishing Services
- Case Study: argenx's BLA rolling submission project:
- Demonstration of eSUBmanager – for effective submission review
- Q & A
Date: Tuesday, 04 May 2021 | 09:00h EDT (New York, Philadelphia) | 14:00h GMT (London, Lisbon) | 15:00h CEST (Berlin, Paris)
Duration: 60 Minutes | If the time does not fit for you, register anyway and we will send you the link to the recording.