This one-day course will provide the concept, strategies and tools for understanding chemistry, manufacturing and control (CMC) decisions to support Investigational New Drug (IND) submission. The seminar consists of presentations based on actual experiences, a tour of SwRI’s cGMP manufacturing facility and real-world group interaction exercise to help you practice tackling real drug development issues to support IND submission.
This course has been assembled for the beginner in CMC as well as the intermediate CMC professional who is looking for a refresher course in several aspects of CMC.
Course Level: Beginner/Intermediate
For more information, please contact Varsin Archer.
This course allows you to understand the complex processes that are vital to successfully bringing a small molecule drug substance/drug product to market. You will also be able to recognize the critical challenges, decisions and consequences along the development path. Interact with experts and colleagues from a wide range of pharmaceutical industry disciplines and meet new colleagues working in drug development.
The course cost is $650 USD per registrant. Registration includes one day of course instruction, training material provided to download, facility tour, lunch and networking reception. Space is limited to 30 participants.
- CMC introduction
- Technical Transfer and introduction to process chemistry
- Formulation and analytical development
- cGMP manufacturing
- Non clinical safety and efficacy
- IND submission
- Cost overview for all aspects of IND submission