Training courses on Drug Development and CMC
CMC is the aspect of MAKING drugs and biologicals at pharmaceutical quality standards, in compliance with GMP and other regulations
Free on-demand mini-course
The Journey of Drug Development
Quickly understand the big picture of Drug Development:​
Enroll for free:
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The clinical phases
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Drug manufacturing and CMC
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The regulatory framework
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Career paths in Pharma
Ideal for those that just need a quick orientation to the field- no prior knowledge assumed.
Students, young-professionals, and experienced professionals from other fields- this one is for you!
Seasoned professionals in Pharma- send this to your junior teams and colleagues who are starting their way in the field.
On-demand mini course
The Full Story of CMC (a.k.a CTD Module 3)
Learn the high level picture of CMC:
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The Regulatory-CMC Framework and ICH Guidelines
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Product modalities and the QTPP
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Manufacturing development, GMP and CDMOs
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Quality Assurance, Quality Controls and Quality By Design
Ideal for those that need a quick (yet comprehensive) overview of Drug Manufacturing at Pharmaceutical Standards, a.k.a CMC
CEOs, Project managers, Business Development, Quality professionals - this one is for you!
On-demand OR Live: Deep dive, 10 weeks course
The CMC Essentials Training course
Deep dive introduction to CMC Development:
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Speak the language of CMC with your team, service providers and Regulatory Authorities
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Fully understand the regulatory framework and relevant guidelines
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Reduce development risks and apply the principles of QBD and Phase-appropriate GMP
Ideal for those that need a full orientation to properly operate within the realms of CMC development.
CMC Project managers, CMC- QA, RA-CMC professionals - this one is for you!
The course is available both on-demand and in live cohorts, several times a year.
All Beyond CMC Students are invited to
The Tree Club
Our weekly live office hour for Q&A and discussions on real-life situations
CTD Module 3 Hands-on workshop
Create your own working copy of the Quality (CMC) sections of an IND / IMPD
In this laser focused, 8-weeks workshop, we will create together your first version (or update) of the CTD Module 3- which is the standard format for the Quality (CMC) sections of all regulatory submissions (IND/IMPD/NDA/BLA)
Ideal for:
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Early phase / preclinical startups that can't afford expensive regulatory consultants/agencies to write their Module 3, but want to advance their regulatory portfolio and save time and money later on
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Regulatory teams that need help training junior staff on CMC in general and Module 3 writing