Becoming an EU QPPV

Dr. Monica Buchberger is Senior Director Pharmacovigilance at PharmaLex GmbH. She is a Pharmacist with more than 20 years of experience in the pharmaceutical industry in functions with global and local accountability. Monica also has wide experience in Pharmacovigilance, Regulatory Affairs and Quality Assurance.

Dr. Buchberger has EU-QPPV experience for Top 10 Pharma Company and has proven excellent leadership and management skills in international environments.  Her main specialties are: international pharmacovigilance and regulatory legislation, mergers/acquisitions and spin-offs (portfolio integration, separation), leadership strategies.

As her core-values Monica points: solution-orientated, ownership, diligence, measured risk-taking, empowerment.

Angela Sebastiany is Director Pharmacovigilance Germany ‖ Head of PV Team (Frankfurt) at PharmaLex GmbH. She has more than 10 years of experience in Pharmacovigilance (PV), PV Quality Management & Compliance. Angela has Pharmaceutical qualification and holds a Master’s degree in Nutritional Sciences. She is an International Service Lead, responsible for global PV system and PV service compliance at PharmaLex, Additionally, she has broad experience as GVP Auditor with audit activities performed worldwide. Among Angela’s core competencies are: set-up, assessment and improvement of local and global PV systems and processes, as well as ensuring compliance with quality related and regulatory PV requirements.

Prof. Asena Serbezova is a pharmacist with more than 20 years’ experience in pharmacovigilance both in clinical development and post-authorization phase.  She graduated from the Medical university-Sofia (1996) and she obtained PhD 10 years later in social medicine and organization of healthcare. In 2008, she returned to her alma mater university as an assistant professor of social pharmacy and pharmacoeconomics. In 2018, Asena Serbezova was appointed as full professor in the Department of health policy and management at the Faculty of public health, Medical university-Sofia. From 2014 to 2018, she was the Executive Director of the Bulgarian Drug Agency at the Minister of Health, and was also a member of the Management Board of the European Medicines Agency. In 2020, she was elected as a president of the Bulgarian Pharmaceutical Union. In December 2021, prof. Serbezova took the position of health minister in the newly formed government. Prof. Serbezova has Helen has over 25 years of experience within pharmaceutical marketing, quality assurance, pharmacovigilance and clinical site auditing, GMP&GDP auditing, Quality Management Systems (QMS) and regulatory compliance. After the appointment of a caretaker government in August of this year, Prof. Serbezova returned to the responsibilities of her main expertise in the field of pharmacovigilance, quality assurance and GXPs auditing including pharmacovigilance audits. Asena Serbezova is an author and co-author of more than 150 scientific articles, books and manuals in the field of quality assurance, pharmaceutical legislation, pharmacoeconomics, utilization of medicines and food supplements and auditing.