Drug Development Process Course
Gain expertise in the drug development process for biologics and monoclonal antibodies, covering preclinical planning, IND/CTA submissions, clinical trial strategies, CMC requirements, and orphan drug pathways. Learn to handle FDA and EMA regulations effectively to speed up the delivery of safe and potent therapies to patients.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
This course offers a detailed, step-by-step guide on advancing monoclonal antibodies from preclinical research to approvals in the US and EU. Explore key regulatory routes, IND/CTA and BLA/MAA standards, CMC and GMP guidelines, strategies for rare disease trials, orphan and accelerated programmes, risk assessment, pharmacovigilance, and commitments after approval to enhance biologics development.
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 autoimmune studies.
- Manage risks and safety through REMS/RMP planning, pharmacovigilance, and post-approval monitoring.
- Utilise expedited pathways by obtaining orphan status and Fast Track or PRIME programmes.
Suggested summary
Before starting, you can change the chapters and the 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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