Biologics & Biosimilars Regulatory Affairs Training Program at Cairo – Egypt

Time 29th, 30th of November 2025

Venue: Princess Fatma Academy, Al Zahraa Mosque, Al Estad, off Mamdouh Salem St. Cairo, Egypt

Learning Objectives

This training program is designed to provide a comprehensive yet practical overview of Biologics and Biosimilars regulatory affairs. The course balances scientific fundamentals, manufacturing insights, and global/local regulatory frameworks, ensuring participants build both conceptual clarity and hands-on understanding.

Targeted Trainees

• Pharmacists and doctors working in R&D of biopharmaceutical companies
• QA and QC professionals in the biologics sector
• Regulatory Affairs and Clinical Research staff seeking foundational training

Trainer’s Name

1. Professor Dr. Ayman M. Noreddin, Ph.D. Is an Egyptian-Canadian academic leader and researcher with over three decades of progressive experience in higher education administration, research innovation, and strategic program development. Dr. Noreddin has Over 150 publications in high-impact journals.
2. Dr. Asmaa Hussein is a distinguished Regulatory Affairs Consultant and the Founder & CEO of Bayt El Khebra El Dawaeya — a leading consultancy specialized in pharmaceuticals, biologics, biosimilars, medical devices, cosmetics, and biocides.

Day 1

Module 1: Fundamentals & Global Landscape

• Introduction to Biologics & Biopharmaceuticals: definitions, evolution, and market trends
• Distinction between Synthetic, Biotech, and biological products
• Global regulatory overview (FDA, EMA, WHO, EDA)

Module 2: Biologics Development & Manufacturing

• Development pathway for innovator biologics: from discovery to approval
• Basics of cell line development and biotechnology platforms
• Upstream & downstream manufacturing processes simplified
• Core GMP & Quality principles for biologics

Day 2

Module 3: Biosimilars Development & Comparability

• Understanding biosimilars vs. generics
•  “Totality of Evidence” approach in practice
•  Analytical, non-clinical, and clinical comparability requirements
• Case examples from global biosimilar approvals

Module 4: Regulatory Pathways & Registration

• Key frameworks: EMA, FDA, WHO, Egypt (EDA)
• Core CTD requirements for biologics and biosimilars
• Registration challenges & local adaptation needs
• Practical dossier preparation & submission insights