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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:

    • Key guidelines and how to use them

    • Highlights on GMP

    • Module 3 of the CTD

    • Phase-appropriate GMP

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  • We expand on the main pillars of CMC and review:

    • Types of drug products- from small molecules, to cell therapies, and from pills to parenterals.

    • Manufacturing processes (Upstream, downstream, aseptic and all that's in-between)

    • 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:

  • Management and Business Development teams

  • Non-CMC R&D

  • Medical experts

  • Upper management

  • Computer and data scientists, joining the Pharmaceutical Development world as part of the industry transition towards Pharma 4.0

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Newcomers to the field are welcome!

  • Students in Science and Engineering fields who wish to know what there is to know and understand the professional directions they encounter

  • Professionals from other fields, joining Drug Development and need a quick tour to the field.

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Curriculum and Housekeeping

​Module 1 - The Journey of Drug Development- also available for free

    • The Clinical Phases 

    • Drug manufacturing and CMC

    • The Regulatory Framework of Drug Development

    • Career paths in Pharma​

  • Module 2 - The Full Story of CMC

    • The Regulatory Framework of CMC

    • The Product- Chemistry, Biology and QTPP

    • Manufacturing Ops, Development and GMPe

    • Quality: Controls, Assurance and Design (or.. QC, QA and QBD)

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  • The course is self-paced interactive and includes:

    • ~2 hrs of ​Video-lessons are available on-demand 

    • 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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