Complimentary Webinar: Clinical Trial Regulation - Background and Safety Reporting

EXTEDO invites you to its Complimentary Webinar "Clinical Trials Regulation - Background and Safety Reporting".

The Clinical Trials Regulation was first put into effect on 16 June 2014. However, the regulation had to be postponed due to a bottleneck in developing a fully functional EU clinical trials portal and database, which is the backbone of the new regime for clinical trials in Europe. On 31 January 2022, the new EU Clinical Trials Regulation became effective.

With the overarching goal to “ensure a greater level of harmonization of the rules for conducting clinical trials throughout the EU” (see European Commission’s overview), this new regulation replaces the Clinical Trials Directive.
 
In this webinar, our speaker, Dr. med. Reinhard Nibler will introduce you to the background information of the Clinical Trials Regulation and the Safety Reporting regarding the newly enacted regulation of the EMA.

After the theoretical part, Dr. Andrea Striebel will demonstrate how the requirements of the Clinical Trials Regulation are implemented in EXTEDO´s drug safety management solution, SafetyEasy.

Agenda

1. EXTEDO corporate intro
2. Clinical Trial Regulation - Background and Safety Reporting
3. Demonstration of working with SafetyEasy in the framework of clinical trials
4. Q&A session

Time and Date

Thursday, 03 March 2022, 09:00 h GMT (London) | 10:00 h CET (Berlin) | 14:30 h IST (Mumbai)

Duration: 60 Minutes | If the time does not fit for you, register anyway and we will send you the link to the recording.

Register now