Drug Development Process Course
Gain expertise in biologics and monoclonal antibody development, covering preclinical planning, IND/CTA submissions, clinical trial strategies, CMC requirements, and orphan drug pathways to meet FDA and EMA standards and speed up delivery of safe therapies to patients.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Explore the step-by-step drug development journey for monoclonal antibodies from preclinical stages to US and EU approvals. Cover regulatory routes, IND/CTA and BLA/MAA needs, CMC and GMP standards, rare disease trial strategies, orphan and fast-track options, risk handling, safety monitoring, and ongoing post-approval duties to boost effective biologics advancement.
Elevify advantages
Develop skills
- Navigate biologics regulations by mastering FDA, EMA, IND, CTA, and BLA/MAA essentials.
- Develop CMC strategies for monoclonal antibodies with efficient, compliant processes from cell line to dossier.
- Design rare disease trials using PK/PD-focused approaches for small-sample studies.
- Manage risks and safety through REMS/RMP planning, pharmacovigilance, and post-approval monitoring.
- Utilise expedited pathways to gain orphan status and access Fast Track or PRIME programmes.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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