Khaberni - As part of the efforts of Amman Arab University to enhance the quality of its academic programs and connect them with experts in the job market, the Faculty of Pharmacy organized a scientific lecture for Master's students in drug monitoring and regulatory affairs under the title: "Biosimilars: Scientific and Regulatory Perspectives " , within the course "Special Topics" supervised by ProfessorDr. Rana Abu Hueij Dean of the Faculty of Pharmacy, presented byDr. Mohammed Alsakar, Associate Professor of Pharmaceutical Biotechnology andVice Dean of Student affairs at the Jordan University of Science and Technology and member of the Technical Committee for Drug Registration at the Public Food and Drug Corporation.
Where the lecture discussed the basic concepts of biosimilars (Biosimilars) , highlighting the differences between them and reference biologic drugs in terms of molecular structure, complexities of manufacturing processes, and regulatory requirements necessary to demonstrate similarity in quality, efficacy, and safety, Dr. Alsakar also presented an overview of the legal and regulatory frameworks adopted for registering these products and the role of regulatory bodies in evaluating and approving them, in addition to highlighting the importance of pharmacovigilance systems in monitoring their safety and effectiveness post-marketing, and the lecture addressed practical aspects in clinical practice, including issues of substitution and switching, and the importance of tracking the drug effect (Traceability), alongside emphasizing the central role of the pharmacist in raising awareness and promoting the rational and safe use of these advanced biologic treatments, and the lecture witnessed a distinctive scientific interaction from the students, reflected through constructive discussions and specialized questions, indicating their level of awareness and interest in the regulatory and practical aspects of this vital field, and contributing to enhancing their readiness to engage efficiently in the job market.
And this lecture is part of the approaches of the Faculty of Pharmacy at Amman Arab University to host distinguished national experts, and enrich advanced courses with modern topics that keep pace with global developments in the pharmaceutical industries and regulation and monitoring, thus preparing qualified pharmaceutical personnel who possess specialized knowledge and professional skills necessary in the field of pharmacovigilance and regulatory affairs.
