Module 3 2019

CMC Project Management

➢ CMC project management is essential to the delivery of all drug development programs. ➢ CMC project management requires a high level of technical knowledge to balance project acceleration and quality . ➢ The effective CMC project manager aims to fully integrate the deliverables of the CMC development plan within the objectives of the drug development team. ➢ This is achieved by keeping CMC development off the critical path (where possible) and by delivering nonclinical- and clinical trial materials on time and within budget.

CMC Project Management

The Organisation for Professionals in Regulatory Affairs