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Master the Fundamentals of CMC Development 
in

The "CMC Essentials" Training Course.

CMC (Chemistry, Manufacturing, and Controls) is a critical aspect in every drug development project.

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People in CMC-related positions are in charge of:

  • Developing the manufacturing processes and quality controls for the new drug

  • Ensuring a constant supply of the new drug to clinical trials

  • Communicating these aspects with the Regulatory Authorities 

    ....and much more!

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This course is designed to give you a comprehensive overview of the entire field of CMC Development and the Regulatory framework of CMC.

This course will help you speak the language of Drug Development and CMC:

With your teams, consultants and experts

With your service providers and CDMOs

With the Regulatory authorities

Who Is This Course For?

This course is tailored for early-career professionals in CMC-related departments  of Startups and Service providers (CDMOs, Consulting firms, etc.):

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  • Project managers 

  • Quality Assurance (QA)

  • Quality Controls (QC)

  • Regulatory Affairs (RA-CMC)

  • Manufacturing operations and development

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Not you?

You may prefer this shorter overview on Drug manufacturing- CMC, GMP, Quality and Regulatory aspects- available here

What you will learn:

  • Understand the Regulatory framework of CMC and how it evolves over the lifetime of the project (Phase-appropriate GxP)

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  • Understand the real-life aspects of CMC development- from the nuances of specific products, to the general principles of GMP and Quality Risk Management

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  • Understand Module 3 of the CTD and draft its sections for your project

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  • Know how to select a CMO and kick start an outsourced manufacturing project

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  • Understand key terms in Manufacturing Science and Technolgy

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  • Identify potential CMC gaps and pitfalls in your current project

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  • Better engage with Subject matter experts in ​​​Manufacturing Ops and MSAT, Quality Control (QC) and ​other technical experts

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  • ​​Understand ​Manufacturing Development and Operations, and how to apply the  principles of QBD in the daily work of CMC

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  • Understand the potential impact of Pharma 4.0, Machine learning, AI, blockchain on the very near future

CMC Essential concepts - from start to end.
See full curriculum here
 

Meet the instructor

Hi there! I am Raz Eliav, a CMC Development and Regulatory Affairs professional working with startups at all phases of development, and of diverse product modalities- mostly biologicals and advanced therapies.

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I am passionate about Science and Technology, and Drug Development is a perfect playground for those who share the same passion.

 

I hope you will enjoy this course, and it will be of value to your professional skills and development! 

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Read more about me and download my CV here

Here is a quick word of introduction to the course content:

What others are saying?

COO in a SaaS Startup:

The module three roadmap was helpful. I enjoyed listening to the flow and relationships between sections.

Head of Quality in a SaaS Startup:

You can tell by the energy and eagerness Raz brings to his classes that he is passionate about teaching. Combined with his extensive experience as a CMC drug development veteran, the level of engagement he provides makes learning more captivating and memorable for students, enhancing knowledge retention and applicability.

 

The curriculum is comprehensive, not only detailing CMC specifics, but touching upon the CMC department's interactions with the regulatory and quality assurance departments, amongst others. Small and large molecules are discussed, and nuanced topics such as challenges faced by small and virtual companies.

Lead Scientist in a Cell-therapy startup:

As a beginner, I found the "CMC Essentials" course to be an excellent introduction to the field. The course was engaging, comprehensive and well-presented. I have definitely gained a valuable knowledge.

Data scientist in Software development:

For me with limited knowledge in the pharmaceutical production domain, it was very helpful 

Project manager in a CMO:

Loved the way it gave an overview of CMC world. Was extremely easy to follow-through.

Choose you course format:

  • The course is available in two formats:
    • On-demand + weekly Q&A meetings
    • Live online- twice a year

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  • ​For the on-demand​ version- register below

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  • The Live course runs under the roof of Educo Life Science- use coupon code BEYONDCMC for extra discounts:  See details and register here. ​

Cost

1499 $ USD

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If you need a brochure for your employer- contact us

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​Students, people between jobs, and emerging markets: please contact for scholarship. Please include a link to your Linkedin profile (if available) and mention your country of residence and Academic/Employment status

What you get

  • 12-months access to training portal which includes:

    • On-demand course (~15 hours total)

    • Student's Q&A forum 

    • Additional resources

    • The Tree club office hour:  a live Q&A and discussion  meeting (Zoom) - Usually takes place on Thursdays @ 15:00 CET / 09:00 AM ET

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  • Course completion certificate

How to register?

  • Use the button  below for Credit Card / Paypal payment​

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enroll now
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