Webinar exclusively for members!

SARQA in collaboration with DARQA (Dutch Association of Research Quality Assurance Professionals) and DKG (Danish Quality Assurance Group) invites all members to a free online webinar – “Serious about Breaches – GCP Insight for a Positive Process” – on December 12^th, 10.00-12.00. The program is currently being refined and more information will be posted.

Confirmed speakers are: Diederike van der Harst, GSK The Netherlands and Louise Mawer, Mirabilitas Ltd UK. Yet to be announced – experienced senior QA from international CRO.

This comprehensive webinar is designed for clinical research professionals seeking to deepen their understanding of Serious Breaches of Good Clinical Practice (GCP).

Participants will gain practical insights into the mechanisms for identifying potential serious breaches, learn a systematic approach to assess the severity of deviations and the cooperation between sponsor and CRO, and how to navigate the complex landscape of European (and potentially global) reporting requirements.

The session will also explore real-world experiences regarding regulatory authority follow-up, provide guidance on implementing effective Corrective and Preventative Actions (CAPA), and discuss the potential consequences for companies involved in serious breaches. Equip your team with the knowledge and strategies necessary to proactively manage GCP compliance and mitigate risks associated with serious breaches.

Registration form