The "CMC Essentials" Training course
Working in Pharma and Drug Development is not for the faint-hearted.
It requires in-depth knowledge of many realms: from Science and Medicine to Engineering, Quality, Regulatory Affairs, and more.
It requires experience to know how these realms work together in real life.
And every step of the way, the decisions are costly and risky- so there is little tolerance to mistakes.
This is why in Pharma, each way you look- you find experts speaking jargon and acronyms and dealing with deep nuances you weren’t aware of just yesterday.
We are a knowledge-intensive industry, doing high-risk development, and we rely on experts for a good reason!
This is why it’s so hard to fit in sometimes- especially in the early years.
And this is why it’s so hard to find experienced people to fill in the very sensitive senior positions.
One thing for sure- we are ALL constantly learning, and I am hereto invite you to step up your industry-knowledge to the next level, and learn the nuances of CMC and Drug Development - to the level you need...
Let me 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
What you will learn:
Understand the Regulatory framework of CMC and how it evolves over the lifetime of the project (Phase-appropriate GxP)
Understand the real-life aspects of CMC development- from the nuances of specific products, to the general principles of GMP and Quality Risk Management
Understand Module 3 of the CTD and draft its sections for your project
Know how to select a CMO and kick start an outsourced manufacturing project
Understand key terms in Manufacturing Science and Technolgy
Identify potential CMC gaps and pitfalls in your current project
Better engage with Subject matter experts in Manufacturing Ops and MSAT, Quality Control (QC) and other technical experts
Understand Manufacturing Development and Operations, and how to apply the principles of QBD in the daily work of CMC
Understand the potential impact of Pharma 4.0, Machine learning, AI, blockchain on the very near future
CMC Essential concepts - from start to end, no prior specific knowledge is assumed- See full curriculum below.
Meet the instructor
Hi there! I am Raz Eliav, CMC Development and Regulatory Affairs consultant. In the past 12 years I have worked with startups at all phases of development, and of diverse product modalities- mostly biologicals and advanced therapies.
I started Beyond CMC with a mission to help young professionals and students bridge the gap between what we learn in the Academy, to what we need to know in the Industry.
I constantly learn the cutting edge in order to also help experienced professionals in Pharma stay on-top of the Knowledge and Know-hows in this fast evolving field.
Here is a quick word of introduction to the course content:
Frequently Asked Questions
What is a Mindmap?Mindmapping is a powerful method to capture knowledge and make it accessible. If you landed a jungle, the best you could hope for is a good map. Mindmaps cover intellectual landscapes, and can can smooth out knowledge management challenges. You feel Good (or bad) Knowledge Management Practices when you onboard new team members, go through a gap assessments or due-dilligence, write regulatory submissions and more. The most important aspect of mindmaps is that they preserve context- and context, as we all know, is a crucial ingredient in knowledge and know-how. A fully functional Mindmap can serve as the single point repository for the project, linking together the most basic elements of the raw data and well into the intangible scientific knowledge, industry practice and regulatory framework. Power uses even leverage mindmaps to do project and budget management.
How does it look like?A Mindmap is layered, like an onion- it could describe just the “big picture” of a project, or go all the way through to the finest nuance and details It depends on the authors and time-invested - the more time spent mind-mapping, the more elaborate and valuable it becomes. For the CMC Development of a Pharmaceutical Product, we will work through the initial framework presented below, which is inspired by the CTD structure, introduced in ICH M4Q , Depending on your project, this can be very different at the end, and will continue to evolve:
What is it good for?An mindmap will help you with: Onboarding new team members and consultants Perform gap-assessments Support due-diligence processes Plan and execute Technology transfers Guide your through regulatory submissions and more! You can choose how deep you want to go in creating your map and in presenting your map- depends on the situation and needs.
How does it work?In a focused mind-mapping session we will build an all-encompassing Mindmap of your project/situation. Hopefully, this will be enough to kick-start your own Mindmapping habit, but I am always here to help. The longer you invest Mindmapping, the more useful it becomes- see available options below. We will touch upon all the moving pieces of your CMC development status including: What is known about the API – Science, Technology and underlying engineering impact Manufacturing aspects Analytical and Quality aspects Regulatory landscape, status and open commmitments Business considerations (CMC oriented) Project specific nuances
Service optionsTier-0 Mindmap- Initial project overview and mapping Kickstart your mind-mapping habit! Scope: A 30-minutes hands-on Mind-mapping session with all relevant stakeholders Deliverables: A one-dimensional map telling your entire CMC story, in very high level Confidentiality agreement: Optional Cost: Free - during the pilot phase (ending soon!) --------------------------------------------------------------------------------------------------------------- Tier 1 Mind-map- a detailed CMC overview and roadmap Scope: Session 1: Hands-on mind-mapping workshop with all relevant stakeholders (~3-4 hours) Session 2: Presentation and discussion of CMC Overview and roadmap (~1-2 hrs) Deliverables: A fully functional Mindmap (includes links to source documents, literature and any other information repositories) Deliverable formats: MMAP (Mind Manager)* HTML (Fully functional in any web browser) Picture (as presented in the page above, external links excluded) Hierarchical master document (can serve as a template for Module 3 and other submissions) (optional): online page with functional Mindmap for guest access (helpful in due-diligence and onboarding consultants) Recommended documents to provide (if available): Module 3 Development reports, Regulatory interactions, Company presentations, Service proposals from CMOs and Contract labs, etc. * The technique can be internalized and used independently by using Mindmanager or any other mind mapping software of preference Cost: 3000 USD --------------------------------------------------------------------------------------------------------------- TIer-2 Mind-map(ping) - Ongoing maintenance of project Mindmap Scope and deliverables: A weekly hands-on mind-mapping session with all relevant stakeholders (~1.5- 2 hours) "The knowledge inbox": Open channle for ongoing monitoring of new company knowledge and implementation into the live mindmap Once a quarter: Project-wide training workshop for new employees, consultants, investors, etc. Cost: 3,000 USD/month
- Course is launching on September 1st, 2023
- The course is available to watch on-demand
- We meet once a week for a live Q&A and discussion (Thursdays @ 15:00 CET / 09:00 AM ET)
- You get 1-year acces to the course portal which includes:
- Course materials and extra resources
- Student's Q&A forum
- Recordings of weekly meetings
What you get
12-months access to Course portal which includes:
Training portal and Tree of Knoweldge
Student's Q&A forum and access to weekly meetings
All Treeclub session recordings
Course completion certificate
Crash-course: The Journey of Drug Development + Certificate
Mini-course: The Full Story of CMC + Certificate
The full CMC Essentials Training Course
Participate in live Tree club meetings
Beyond CMC Training platform and mobile app
1-Year access to Tree club recordings and student forum
Tree of Knowledge (Beta)