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PharmaReg AfriSummit 2026

Dr. Imene Ben Mansour

Position: Head of the CMC Evaluation Department for Biological Products, Vaccines, Blood Derivatives and Biosimilars, ANMPS Tunisia
Categories: RA 2026

Senior regulatory expert within the Tunisian National Regulatory Authority, specializing in the evaluation and regulation of biological medicinal products, with particular expertise in vaccines and biosimilars. Currently serving as Head of the CMC Evaluation Department for Biological Medicinal Products, Vaccines and Blood-Derived Products at the National Agency for Medicines and Health Products (ANMPS), Tunisia.

Extensive expertise in vaccine registration and CMC assessment, regulatory reliance, regulatory convergence and regulatory system strengthening, with active involvement in WHO vaccine assessment activities and international and regional regulatory collaboration, including NA-AMRH and ICH initiatives.

Active contribution to the development and strengthening of Tunisia’s regulatory framework through the development and revision of national guidelines for vaccines, biological medicinal products, biosimilars, reliance and post-approval changes. Strong involvement in national initiatives supporting and promoting local vaccine manufacturing, with a role in providing regulatory guidance to local developers and manufacturers and strengthening regulatory readiness for the development and future registration of locally manufactured vaccines.

Bringing together regulatory science, national regulatory strengthening and international collaboration to support vaccine innovation, local manufacturing and improved access across Africa.