Applying ICH Q8 in an Outsourced Operation

Course Overview

Regulatory submissions can make or break a startup in the pharmaceutical industry. The Drug Development process is filled with risks, and approval to progress is never guaranteed. That’s why it’s crucial to invest in accurate submissions that reflect the best available knowledge and interpretations and address all strategic considerations. But we know it’s not an easy feat.

Imagine gaining invaluable tips and tricks to capture project knowledge and streamline your regulatory submission workflow. Picture yourself equipped with the tools to overcome the challenges of managing product and process knowledge across organizations, systems, and information silos. What if you could navigate the complexities of collaborating with multiple subcontractors and consultants with ease? It’s all within your reach.

Join us for a groundbreaking webinar featuring Raz Eliav, a leading expert in CMC Development and Regulatory Affairs. In this exclusive lecture, we will focus on the CDMO-Sponsor relationship and explore how to overcome the difficulties that arise during critical times like regulatory submissions and due diligence. We’ll reveal practical solutions using the Quality Management System (QMS), a regulatory requirement that is readily available to you.

By attending this webinar, you’ll:

1. Discover tips and tricks for using the eQMS system to capture project knowledge effectively.

2. Streamline your workflow of regulatory submissions, even when multiple subcontractors and consultants are involved.

3. Gain insights into leveraging the contextual framework of CTD Module 3 to make project knowledge available and concurrent as needed.

4. Learn how to structure your documents and utilize regulated workflows for concurrent review, saving you time and resources.

5. Uncover the power of the QMS as a tool for knowledge management and regulatory project management.