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The "CMC Essentials" Training course

In Drug Development- Knowledge is essential.
Lack of knowledge- is a risk.

That's why it's hard to find a job without professional experience.

And that's why its hard to onboard new team members at the higher levels of involvement.

The cost of relying on experts is high, but the cost of taking a wrong turn is even higher.

Teams oftentimes find themselves relying entirely on very few (overworked) experts, without building a solid organic team that grows with the project.

We can't know it all, and must rely on others, but wouldn't it be easier if everyone speaks the same language?

From the Junior team member to the seasoned professional - The key to a successful career, and to an efficient team- is continuous training.

The CMC Essentials Training Course will provide you with a comprehensive overview of CMC- which is the aspect of making pharmaceutical products, at the high quality standards we all know.

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

With your team

With your service providers and CDMOs

With the Regulatory authorities

By taking this course you will:

  • Understand the Regulatory paradigm of Drug Approval and the overarching considerations of CMC Development

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  • Understand the real-life implications 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 kick start and manage projects with suppliers and CMOs 

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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

Course topics:

CMC Essential concepts - from start to end, no prior specific knowledge is assumed- See full curriculum below.

The course starts with an on-demand mini-course, that presents the high-level picture of Drug Development and CMC. If you only need an overview, check out the mini-course
 

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  • We will understand nuances that pertain different kinds of drugs: from small molecules to biologicals and cell therapies.

 

  • We will discuss the ways pharmaceutical products are manufactured- either in-house or at contract manufacturing organizations (CMOs), and touch the key aspects in science and technology, as well as the daily management of manufacturing development: selection of CMOs, process development, selection and control of raw materials, cell banks and more. We will also briefly introduce the concepts of process validation 

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  • We will understand the concept of quality and controls- from analytical methods, in-process controls and validation, all the way to Quality by Design. We will imagine where the field is going with some thoughts about Pharma 4.0 and an overview of the current industry thinking on Machine learning, AI, blockchain and more.

 

  • We will learn of the regulatory framework that outlines the work in CMC- from written words in laws and guidelines to the less-formal expectations and industry-standards, and we will see how the CMC requirements evolve over the course of pharmaceutical development.

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Meet the instructor

Here is a quick introduction to the course content:

Raz Eliav is a seasoned CMC Development and Regulatory Affairs consultant. With over 12 years of experience working with startups at all phases of development, and of diverse product modalities- mostly biologicals and advanced therapies.

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Raz started Beyond CMC with a mission to facilitate CMC operations to startups- through:

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  • Training (dedicated and public)

  • Hands-on work with development teams

  • Strategic CMC and Regulatory consulting

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Frequently Asked Questions

Course details:

Date and Time

  • 4 x half-day online seminars 

  • 9:00 - 12:30 EDT / 15:00-18:30 CET*

  • July 10-13, 2023 *

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* Subject to change

What you get

  • 6-months access to Course portal which includes session recordings, additional resources and a Q&A discussion forum

  • Course completion certificate

Cost

  • 1450 $ USD

  • 950$USD with Early birds discount until June 15th.

  • Coupon code: EARLY23 

  • Students, people between jobs, and emerging markets: please contact for scholarship

How to register?

  • Register in the link below for Credit Card payment

  • For comapnies:

    • Group pricing available​

    • Payment by wire possible

  • Please contact for details​

Participation in the live course

6-months access to Course portal and discussion forum

1-on-1 coaching session

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