Drug Development and CMC
How are new drugs discovered and developed?
And... What is CMC?
Precription drugs are one of the tools in the arsenal of modern medicine to cure and prevent human disease. The pursuit of new drugs is helping us overcome many devastating and life-threatening medical conditions, and the huge benefit they bring to humanity is reflected in the ever-increasing value of Pharma companies worldwide.
In this mini-course, you will get a solid overview of the process the industry follows to find new drugs, proving they are safe and effective, and making them in an industrial scale, and to the high standards we call Pharmaceutical Quality.
The course is ~2 hours long, and comprises of two parts:
In the first part we start by setting the context of Drug Development, in a (very) high-level overview:
How are new drugs discovered?
What's the purpose of animal studies and clinical trials?
What do the Regulatory Authorities have in mind when approving new drugs?
- What are the different career paths in Pharma and in Drug Development?
In the second part, we will see how new drugs are manufactured to the high quality standards of Pharmaceuticals. This aspect is called CMC, Short for Chemistry, Manufacturing and Controls:
We will learn:
Why is this called CMC and how it looks like in the world of Biologicals?
What are the main lines of work in CMC Development and how it evolves hand-in-hand with Clinical development?
How the CMC story unfolds in CTD Module 3- the main regulatory document that describes CMC
Who is this for?
Professionals in Pharma and Drug Development
Quick refresher of the Jargon and connections between all the moving parts of Clinical Development, CMC Development and Regulatory Affairs.
Ideal for busy CEOs, Business Development and other professionals at high-level of involvement, that need a quick re-orientation or introduction to newcomers from other fields
Young-professionals and Students
Come hear what's waiting for you out there, after graduation
The course assumes no prior knowledge and will be helpful for you to decide where you want to navigate your career in this vast field
Traditionally, the field attracts people with degrees in the life sciences, chemistry, and engineering, but in today's industry: computer and data scientists are in high demand!**
If you cant afford to pay for this course, please E-mail us for a Scholarship code
Experienced RA / QA / CMC professionals
- I invite you to Peer-review this, and use this in training your new team members
** The Pharma field is stepping quickly into the world of Pharma 4.0 which will harness the power of Machine learning, ML, AI, IoT, and more. So as it evolves there is an increasing demand for Computer and Data scientists, and Engineers of diverse backgrounds.
Come join us!
The course is ~2 hours long, and available to watch on demand
Lectures are broken down into short segments, in addition to a full length audio-only track for those who prefer to listen all the way through
Additional resources such as key Regulatory guidelines and reading materials are available for those who wish to go deeper
This mini-course is introduction part of "The CMC Essentials Training Course"- which is a deeper dive into the nuances of CMC. If you take this mini-course and then decide to go deeper, E-mail us to get a full refund on this course (when you register to the full course).