PG-Diploma in Drug Regulatory Affairs-Biologics and Biosimilars (Regular course)
Chapter-1: Course introduction on Biologic & Biosimilars, Key Process Input materials (6 hours)
Chapter-2: Drug Substance- Upstream process development and manufacturing scale-up (QbD) (6 hours)
Chapter-3: Drug Substance- Downstream process development and manufacturing scale-up(QbD) (23 hours)
Chapter-4: Pharmaceutical Quality Management System-QMS (10 hours)
Chapter-5: Analytical methods development, method transfer and methods validation (10 hours)
Chapter-6: Drug Product development and manufacturing scale-up (QbD) (8 hours)
Chapter-7: CMC-Module-III dossiers authoring and modules preparation (12 hours)
Chapter-8: Module-I, II, IV & V dossiers overview with case studies and modules preparation(6 hours)
Chapter-9: Biologics & Biosimilars filing in Domestic, ROW & Regulated markets (8 hours)
Chapter-10: Trainee Assessment and Evaluation followed by certification (1 hour)
