ICH M4Q(R2) Webinar: Modernizing CMC Submissions

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Overview What You Will Learn Webinar Speakers

Overview

M4Q(R2): The Road to Pragmatic, Modernized CMC Submissions

Where

Online Webinar

When

10:00 AM ET

The ICH M4Q guideline, which defines how pharmaceutical quality information is organized within the Common Technical Document (CTD), is undergoing its first major revision in over two decades. The proposed M4Q(R2) draft introduces a more structured and lifecycle-focused framework that reflects how modern product development and regulatory processes have evolved.

To help regulatory and CMC professionals understand the implications of this update, Celegence is hosting a webinar: “M4Q(R2): The Road to Pragmatic, Modernized CMC Submissions”.

This interactive session will provide insights into the evolution of M4Q, the most significant changes in the revised guidance, and how they will reshape how CMC data is documented, reviewed and maintained across the product lifecycle.

Who Should Attend?

This session is designed for professionals in:

Regulatory Affairs
Quality Assurance
Technical Writing and Documentation
Clinical and CMC Management

Why This Update Matters

The proposed M4Q(R2) revision aims to modernize the presentation of quality data and improve lifecycle management of CMC documentation. With new emphasis on Core Quality Information (CQI), Development Summary & Justification (DSJ), and Product Lifecycle Management (PLCM), representing a shift toward structured, modular, and reusable content.

By focusing on clarity, consistency, and traceability, M4Q(R2) intends to enhance regulatory review efficiency and enable better alignment between global health authorities and industry practices.

What You Will Learn

This webinar will help participants:

Understand the evolution of ICH M4Q and the need for change
Recognize the key improvements in ICH M4Q(R2) compared to the current M4Q(R1)
Evaluate how the proposed changes will affect CMC documentation, dossier structure, across product types

Webinar Speakers

Principal SME, Pharmaceutical Services

Maurice Bancsi

Based in the Netherlands, Maurice has over 27 years of experience in the pharmaceutical and biotech industry. His expertise spans regulatory strategy, cross-functional team leadership, and health authority interactions at both national and EU levels. Maurice has supported numerous pre-approval drugs and biologics across oncology, pulmonary, and cardiovascular indications. His extensive background includes leading the development of key regulatory applications such as MAAs, CTAs, Orphan Drug Applications, PIPs, iPSPs, IND Annual Reports, and DSURs.

Join the Discussion

The ICH M4Q(R2) update will reshape how CMC data is authored, reviewed, and maintained across the product lifecycle. Don’t miss this opportunity to gain clarity on the proposed changes and prepare your organization for the next generation of CMC submissions.

M4Q(R2): The Road to Pragmatic, Modernized CMC Submissions

Register for the webinar

Downloadable Resources and Registration

Overview

Where

When

Who Should Attend?

Why This Update Matters

What You Will Learn

Webinar Speakers

Join the Discussion

Where

When

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