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 main moving parts of Drug Development:
Enroll for free:
The clinical phases
Drug manufacturing and CMC
The regulatory framework
Career paths in Pharma
Ideal for those that just need a quick orientation to the main pillars of 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 might find it useful.
On-demand mini course
The Full Story of CMC (a.k.a CTD Module 3)
Learn the high level picture of CMC:
The Regulatory-CMC Framework and ICH Guidelines
Product modalities and the QTPP
Manufacturing development, GMP and CDMOs
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:
Speak the language of CMC with your team, service providers and Regulatory Authorities
Fully understand the regulatory framework and relevant guidelines
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 meeting 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 a 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)
Early phase / preclinical startups that can't afford expensive regulatory consultants/agencies to write their Module 3, but want to advance their regulatory portoflio and save time/money later on
Regulatory teams that need help training junior staff on CMC in general and Module 3 writing