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Drug Development Process Course

Drug Development Process Course
from 4 to 360h flexible workload
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 standards, rare disease trial design, orphan and expedited programmes, risk management, pharmacovigilance, and post-approval obligations to support faster and 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.
Workload: between 4 and 360 hours

What our students say

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EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Great course. A lot of valuable information.
WiltonCivil Firefighter

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