The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
The VirtualPharm
Developing a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH Guidance
In this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirements of each target market, harmonize CMC data and documentation across regions, and establish a comprehensive quality system. The article also highlights the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in harmonizing regulatory requirements and supporting a cohesive approach to CMC globally.