We are delighted to share that Ajla Mušić, M.Sc.Pharm, Pharmacovigilance Officer at Billev Pharma East Ltd., held a highly informative webinar on December 2nd titled “Ensuring Safety and Compliance – From Technical Documentation to Clinical Evaluation”.  This engaging session was designed to guide participants in navigating the complexities of preparing technical documentation and clinical evaluations to meet regulatory standards in the medical device industry. The webinar was organized by TOPRA on behalf of Billev Pharma East.

72 participants attended in total and key topics were covered including:

• Comprehensive Technical Documentation – its role in ensuring device safety and compliance.
• Best Practices for MDR/ISO 13485 Compliance – strategies for maintaining compliant technical files.
• Clinical Evaluation Reports (CER) – core elements and their importance in regulatory submissions.
• Overcoming Documentation Challenges – practical solutions to common hurdles in clinical evaluations.
• Integration of Clinical Evaluations – ensuring safety and compliance through a holistic approach.

The session concluded with a 15-minute Q&A segment, where important questions were addressed, providing participants with actionable insights.

We thank TOPRA for their collaboration in hosting this successful event and all attendees for their active participation. Stay updated for future initiatives aimed at advancing regulatory excellence!