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Sofitel Casablanca Tour Blanche

Feb 27, 2018 3:00 PM - Feb 28, 2018 9:00 PM

Rue Sidi Belyout, Casablanca, 20190, Morocco

1st Regional Conference on Regulatory Harmonisation

SESSIONS 3: BIOTHERAPEUTIC & BIOSIMILARS

Session Chair(s)

Dounia   El Maimouni

Dounia El Maimouni

JANSSEN, France

Anne  Grandjacquot

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)

Sameh  Ben Tkhayat

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

Wiame Lakhlili

Laboratoire National De Contrôle Du Médicament, Morocco

Pharmacist Assessor

Rebecca  Lumsden, PhD

Focus on Global Regulatory Pathways and Challenges for Biosimilars

Rebecca Lumsden, PhD

Sanofi, United Kingdom

Head of Regulatory Science & Policy EU/AMEE

Mhammed  Mouani

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

Yacine  Sellam, PharmD, PhD

Algeria: Lessons Learnt from Local Experience with Biosimilars

Yacine Sellam, PharmD, PhD

Algerian Society for Regulatory Affairs & Pharmacoeconomics (SAARPE), Algeria

President

Rachida  Soulaymani-Benchei

Rachida Soulaymani-Benchei

Centre Anti Poison Et De Pharmacovigilance Du Maroc, WHO Collaborative Center, Morocco

Director

Klara  Tiitso, MSc

Existing Guidelines

Klara Tiitso, MSc

European Medicines Agency, Netherlands

Quality Specialist,

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