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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:

  • The Regulatory framework of CMC:

    • Key guidelines and how to use them

    • Highlights on GMP

    • Module 3 of the CTD

    • Phase-appropriate GMP

  • 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

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

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.

Housekeeping

  • You will gain access to Module 1 (The Journey of Drug Development) and Module 2 (The Full Story of CMC). The rest of the modules belong to the CMC Essentials Training Course

  • The course is self-paced interactive meaning:

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

    • Student's forum open for Q&A  and discussion

    • Live weekly meeting for Q&A in The Treeclub (Usually Thursdays @ 15:00 CET/ 09:00 ET)

  •  1-month access to the course materials and the Tree club sessions.

99

Crash course: The Journey of Drug Development + Certificate

Mini-course: The Full Story of CMC + Certificate

Participate in live Tree club meetings

1-month Access to Tree club recordings and student forum

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