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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?

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.
Workload: between 4 and 360 hours

What our students say

I was just promoted to Intelligence Advisor for the Prison System, and the course from Elevify was crucial for me to be chosen.
EmersonPolice Investigator
The course was essential to meet my boss's and the company's expectations.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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