When: On-demand - This is a recording of the live webinar which took place on 10 April 2017.
Overview
Drug development requires a team approach to be successful, one of the participants in this process is the Chemistry, Manufacturing and Controls (CMC) function.
In a dynamic regulatory environment the role of CMC starts in early Phase I clinical submissions and continues through the later stages of Phase II and III and ultimately supports the application and licensing activities for the pharmaceutical compounds to achieve market commercialisation.
This webinar will provide an introduction to the role CMC plays in the global development process and highlights some of the challenges encountered.
Learning Objectives
- Outline the format of the Common Technical Document (CTD) for the registration of Pharmaceuticals for Human Use: Module 3
- Introduce the role of global CMC during development both at the early and later stages
- Highlight CMC submission expectations, with differences across the development stages
- Introduce the development of the CMC regulatory filing strategy taking into account key areas for consideration
Presenters
Sarah Fitzgerald, Director, Global CMC, Pfizer
Patricia Corrigan, Senior Manager GCMC, Pfizer
CPD
This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.
How do I apply?
Simply login or create an account and register below.
Course fees:
| Type |
Member |
Non-member |
| Standard |
£75+VAT |
£95+VAT |
3 for 2 Global Development webinar offer
Purchase 2 webinars from our global development series and receive one free. Find out more here. |
Terms and conditions
Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.