Despite efforts to harmonize the reporting obligations and globally streamline the reporting process for clinical trials, challenges arising from divergent requirements and standards still exist internationally. For example, the FDA has relatively recently published new regional fields for expedited XML safety reporting, for that matter.
In this webinar, Stavros Kardahakis PhD (Senior Business Consultant, EXTEDO) will discuss clinical trial reporting requirements in the US and draw insights in comparison to their counterparts in the EU.
After the theoretical part is complete, we will demonstrate how to create a SUSAR and work in the framework of clinical trials with EXTEDO´s Drug Safety management solution, SafetyEasy.
Following the presentation, we will answer your questions in the Q&A session.
1. EXTEDO corporate intro
2. Clinical Trial reporting requirements in the US and references to EU
3. Demonstration of working with SafetyEasy in the framework of clinical trials
4. Q&A session
Time and Date
Thursday, 16 September 2021, 09:00am EDT (New York) | 02:00pm BST (London) | 03:00pm CEST (Berlin)
Duration: 60 Minutes | If the time does not fit for you, register anyway and we will send you the link to the recording.