CMC, Chemistry, Manufacturing and Controls is the umbrella term we use in the industry to describe all the aspects of making pharmaceutical products, in pharmaceutical grade and in compliance with Good Manufacturing Practices (GMP) and other regulations. CMC Development is one of the main pillars of Drug Development, and it goes hand-in-hand with clinical development. If you wish to know a little more about the field before jumping both feet it, please check our free crash course: Crashcourse.BeyondCMC.com

The course curriculum (subject to adjustments): Pharmaceutical Development - Overview and context (**Also available as a standalone, free crash course- check it out here)(Crashcourse.BeyondCMC.com) • The journey of drug development: - from bench to bedside • Introduction to CMC and the CMC Triangle • The Regulatory framework of drug development • Overview of career paths in the pharmaceutical industry The full story of CMC (a.k.a Module 3 of the CTD)text (**Also available as a standalone, mini course- check it out here)(https://www.beyondcmc.com/mini-course) • The Regulatory Framework of CMC • The Product- Chemistry, Biology and QTPP • Manufacturing Ops, Development and GMP • Quality: Controls, Assurance and Design The Science and Technology of CMC • Types of pharmaceutical products and their nuances- from Small Molecules to Cell Therapies • Key Manufacturing Technologies- Principles of organic chemistry, Molecular Biology, and common Upstream and Downstream technologies Manufacturing sites and GMP • Manufacturing sites (In-house/CDMOs) and CMO Selection • Good Manufacturing Practice 101 • From Lab to GMP- a typical development workflow Manufacturing Process Development (Drug Substance) • Upstream Process Development, Starting Materials and Cell Banks • Downstream Process Development • Process "lock" and Comparability (intro) Pharmaceutical Development and Product Lifecycle • Pharmaceutical and Formulation Development • Drug Product Process development • Containers and Labelling • Case studies of specific product types • Comparability • Technology Transfers Know thy product- Characterization and Impurities • Characterization principles and techniques • Types of impurities and their significance in product safety/efficacy Quality Controls (QC) • Analytical methods overview • Quality Controls (QC) and Specifications • ·Analytical methods lifecycle and validation When the product meets the world • Stability and shelf life • CMC operations and product logistics Quality and Design • Quality Assurance (QA) • Pharmaceutical Quality Systems • Quality Risk Management • Introduction to QBD The view from the top of the development mountain • Quick recap of all course topics • Pharma 4.0, PAT, IoT, Big Data and current tech stack • Predictive modelling and AI Final quiz and course certificate

Professionals in CMC-related departments such as: • CMC Project managers in startups and service providers • Quality Assurance (QA) • Quality Controls (QC) • Regulatory Affairs (RA-CMC) • Manufacturing operations and development Professionals within Drug Developing companies that have daily interactions with CMC Service providers such as CDMOs and service labs Students in Science and Engineering fields, approaching the end of their studies and considering a career in Pharma (scholarships are available, see below) Professionals from other disciplines that need a quick orientation to Drug Development and CMC, You may prefer this shorter overview, available here (https://www.beyondcmc.com/mini-course) Ideal for: • Management and Business Development • Non-CMC R&D • Medical experts • Upper management • Computer and data scientists, joining the Pharmaceutical Development world as part of the industry transition towards Pharma 4.0

​Not at all! CMC is highly multidisciplinary and attracts people from diverse backgrounds. The majority are indeed, with educational and professional background in Scientific and engineering backgrounds, mainly in the life-sciences and chemistry. Nevertheless, the industry requires experts in higher levels of involvement, such as Project managers, System engineers, Quality Assurance and Regulatory professionals. The course assumes no prior knowledge and each lecture starts with a quick background and additional resources, The Pharma field is stepping quickly into the world of Pharma 4.0 which will harness the power of Machine learning, AI, blockchain, and more. So as it evolves there is a huge demand for Computer and Data scientists and Engineers of diverse backgrounds as well