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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Maria Antonieta Roman
Head Emerging Markets Regulatory Policy at Novartis


Pharmacist. Mexico’s National University (UNAM), master’s in science. 31 years of experience in the pharmaceutical and biological production industries in areas such as: Research and development, Quality assurance and control, quality systems, regulatory affairs and undergraduate and postgraduate teaching. She has collaborated in various pharmaceutical laboratories, such as the National Laboratory of Biologics and reagents in Mexico, as a volunteer at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA, Boehringer-Ingelheim, Stendhal, Sanofi Pasteur and Novartis Mexico as Director of Regulatory Affairs. She has collaborated as an undergraduate and postgraduate teacher at the School of Chemistry at La Salle University. She has been a member of the management teams of various associations in the pharmaceutical industry and currently leader of the regulatory committee of the Swiss-Mexican Chamber of Commerce and Industry, vice president of the Commission of technical directors of the National College of Pharmacists and leader of the "Reliance" sub-group within the regulatory group of FIFARMA, member of the IFPMA reliance group, participant in the Latin American committee of EFPIA and member of the organizing committee of the Latin American conference of the "Drug information association” (DIA) 2022 and 2023. She holds specialized studies in clinical research, health law and pharmaceutical marketing.

She currently holds the position of Head of Regulatory Policy for Latin America at Novartis.

Agenda Sessions

  • Chair’s afternoon remarks

  • Global Reliance and Convergence: Moving Towards Harmonisation