flexible workload from 4 to 360h
valid certificate in your country
What will I learn?
This Drug Development Process Course provides a clear, step-by-step overview of how monoclonal antibodies progress from preclinical studies to approval in the US and EU. You will learn about regulatory pathways, IND/CTA and BLA/MAA requirements, CMC and GMP expectations, rare disease trial design, orphan and expedited programmes, risk management, pharmacovigilance, and post-approval obligations to support faster, more robust biologics development.
Elevify advantages
Develop skills
- Biologics regulatory navigation: master FDA, EMA, IND, CTA and BLA/MAA basics quickly.
- CMC strategy for mAbs: design efficient, compliant processes from cell line to dossier.
- Rare disease trial design: build PK/PD-driven, small-sample autoimmune studies.
- Risk and safety management: plan REMS/RMP, PV, and post-approval evidence.
- Expedited pathways use: secure orphan status and leverage Fast Track, PRIME.
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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