Billev Pharma East was proud to take part in the TOPRA Symposium 2025, held from 29 September to 1 October 2025 in Berlin, Germany. The event gathered leading experts, regulators, and industry representatives from across Europe to exchange knowledge and discuss the most recent updates in regulatory affairs and pharmaceutical legislation.
As exhibitors, our team had the opportunity to present our broad range of regulatory consulting services and to engage in meaningful discussions with professionals from the pharmaceutical and medical devices sectors. The symposium provided an excellent platform to strengthen existing partnerships and to explore new collaborations in the evolving regulatory landscape.
Sharing expertise on digital transformation and electronic product information
We are particularly proud that Katja Pečjak Reven, participated as a Session Leader at this year’s symposium.
Katja co-led the session titled:
“Regulatory implications and readiness strategies for the implementation of electronic Product Information (ePI) based on the HL7 FHIR® standard.”
The session explored the regulatory implications and readiness strategies for implementing electronic product information across the EU. It addressed the current progress of the EU ePI project, connections between ePI and EU medicine packaging, and the impact of upcoming regulatory frameworks. Practical insights were also shared on how regulatory professionals can prepare internal processes and IT infrastructure for the integration of FHIR®-based ePI systems.
The structured and interoperable ePI format will play a crucial role in improving access to reliable product information — a key step toward digital transformation and regulatory harmonisation across Europe.
Commitment to quality and compliance
Throughout the symposium, the Billev Pharma East team also highlighted its experience in GMP consulting, supporting clients in achieving compliance with international quality and manufacturing standards. Our specialists shared insights into effective quality management systems, process optimisation, and documentation best practices.
In addition, we continue to provide comprehensive services in medical writing and pharmacovigilance, helping our partners ensure the scientific accuracy, consistency, and regulatory compliance of product documentation. Our expertise also extends to veterinary pharmacovigilance, supporting the safe use of veterinary medicinal products.
We also provide full regulatory support in preparing and maintaining the medical device technical file, assisting manufacturers throughout the product lifecycle and ensuring conformity with applicable EU regulations.
Looking ahead
Participation in the TOPRA Symposium 2025 in Berlin reaffirmed our dedication to advancing regulatory excellence and digital readiness across the pharmaceutical and medical devices industries.
We thank all visitors and colleagues who joined us during the event — it was a pleasure to exchange ideas, share experiences, and look toward the future of regulatory innovation together.