Veterinary Marketing Authorisation (MAA) and Variations (MAV) in the EU: Regulatory Requirements and Best Practices

Jana started her professional career as a practicing physician, specializing in Emergency Medicine. After almost 10 years in clinical practice, she joined Sanofi’s Medical Affairs team, covering Southeast and Central European countries. Following a short transition to Novo Nordisk, she moved to Billev Pharma East, a consultancy company based in Slovenia. In her current position, Jana is responsible for a team of pharmacovigilance specialists, medical advisors, and veterinary medical advisors, covering human and veterinary pharmacovigilance and providing medical regulatory support to clients.
Her daily work involves preparation of MAA dossiers for human and veterinary medicinal products. She also acts as QPPV for human and veterinary products in the EU and UK.

Suzana Šalinger is experienced CMC regulatory affairs manager with a solution-focused approach. Proficient in drug development processes and life-cycle management across the pharmaceutical industry. Skilled in preparing, evaluating, and analysing quality CMC dossiers for EU/RU/ROW markets. With extensive experience in regulatory affairs, Suzana Šalinger is proficient in coordinating and preparing regulatory submissions and strategies. Her role at Billev Pharma East involves effective communication with competent authorities, clients, and internal departments. She excels in maintaining up-to-date knowledge of European legislation.