Get a high-level orientation to CMC
in our mini-course:
The Full Story of CMC
a.k.a CTD Module 3
In this mini-course, we map out the full picture of CMC.
We discuss:
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The Regulatory framework of CMC:
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Key guidelines and how to use them
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Highlights on GMP
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Module 3 of the CTD
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Phase-appropriate GMP
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We expand on the main pillars of CMC and review:
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Types of drug products- from small molecules, to cell therapies, and from pills to parenterals.
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Manufacturing processes (Upstream, downstream, aseptic and all that's in-between)
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Quality controls, Quality Assurance and of course- Quality by Design
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Who Is This Course For?
This course assumes no prior knowledge in Drug Development and/or CMC:
Ideal for professionals in the field, that need a quick catch-up on CMC:
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Management and Business Development teams
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Non-CMC R&D
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Medical experts
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Upper management
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Computer and data scientists, joining the Pharmaceutical Development world as part of the industry transition towards Pharma 4.0
Newcomers to the field are welcome!
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Students in Science and Engineering fields who wish to know what there is to know and understand the professional directions they encounter
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Professionals from other fields, joining Drug Development and need a quick tour to the field.
Curriculum and Housekeeping
Module 1 - The Journey of Drug Development- also available for free
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The Clinical Phases
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Drug manufacturing and CMC
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The Regulatory Framework of Drug Development
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Career paths in Pharma
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Module 2 - The Full Story of CMC
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The Regulatory Framework of CMC
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The Product- Chemistry, Biology and QTPP
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Manufacturing Ops, Development and GMPe
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Quality: Controls, Assurance and Design (or.. QC, QA and QBD)
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The rest of the modules belong to the CMC Essentials Training Course
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The course is self-paced interactive and includes:
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~2 hrs of Video-lessons are available on-demand
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1-month access to The Treeclub- our Live weekly meeting for Q&A (Usually Thursdays @ 15:00 CET/ 09:00 ET)
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