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SESSIONS 3: BIOTHERAPEUTIC & BIOSIMILARS
Session Chair(s)
Dounia El Maimouni
JANSSEN, France
Anne Grandjacquot
Head of Regulatory Affairs - Africa Region
Sanofi, France
This sessions starts with an intro on biosimilar and dossiers and review the key steps in the development of these type of products. The session will discuss the status of biosimilar regulations in the countries in the region.
Speaker(s)
Tunisia : Update on Regulation & Lessons Learned from Local Experience with Biosimilars
Sameh Ben Tkhayat
Direction De La Pharmacie, Tunisia
Head of Local Industries Department, Coordinator of Biosimilars Committee
Wiame Lakhlili
Laboratoire National De Contrôle Du Médicament, Morocco
Pharmacist Assessor
Focus on Global Regulatory Pathways and Challenges for Biosimilars
Rebecca Lumsden, PhD
Sanofi, United Kingdom
Head of Regulatory Science & Policy EU/AMEE
Morocco: Update on Regulation, Assessment of Biotherapeutics & Biosimilars by LNCM & Pharmacovigilance Related to Biotherapeutics and Biosimilars
Mhammed Mouani
Laboratoire National De Contrôle Du Médicament, Morocco
Deputy Head of the Biological Assays Laboratory
Algeria: Lessons Learnt from Local Experience with Biosimilars
Yacine Sellam, PharmD, PhD
Algerian Society for Regulatory Affairs & Pharmacoeconomics (SAARPE), Algeria
President
Rachida Soulaymani-Benchei
Centre Anti Poison Et De Pharmacovigilance Du Maroc, WHO Collaborative Center, Morocco
Director
Existing Guidelines
Klara Tiitso, MSc
European Medicines Agency, Netherlands
Quality Specialist,
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