Mastering the Common Technical Document (CTD) for Biologics Masterclass - EU edition

12-16 January, 2026

From guidelines to submissions

The Master Class provides ICH M4Q guidance on the format and content of biotech drug registration applications (per Q6B).

12-16 January, 2026, Virtual

Time Zone: UTC/GMT+1/CET

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Key learnings

CMC Data

A comprehensive review of CMC data to be included in an Investigational IND

Regulatory Authorities

Regulatory submission requirements for clinical trials and marketing applications

Quality Section

Outline of CMC data for CTD Modules 2 and 3 Quality sections

ICH Objectives

ICH objectives and CMC guideline overview, highlighting content differences for clinical trial vs. marketing applications.

Application Dossier

What needs to be provided in an application dossier?

CMC Package

Building the CMC package for successful IND/IMPD or BLA/MAA submissions.

Trusted by over 17,000 delegates across leading companies

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Overview

The Master Class focuses on ICH M4Q, providing guidance on the format and content of a registration application for drug substances and their corresponding drug products, as defined in the scope of the ICH Guidelines Q6B for biotechnological products. The Master Class also includes links to other existing ICH guidelines and their contents.

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Trainer

Mylène Talabardon, Phd

Mylène brings 25 years of extensive experience in the biotechnology Mylène brings 25 years of extensive experience in the biotechnology industry, having worked with renowned companies such as Biogenldec, Sanofi, and Merck-Serono. She has demonstrated exceptional leadership in CMC, contributing directly to multiple clinical and commercial drug substance and drug product manufacturing facilities in both technical and management roles. Prior to transitioning to consultancy, Mylène led a multi-disciplinary CMC team to successfully achieve commercial approval for a biosimilar. Her expertise encompasses
process development and validation, innovative technologies, process technology transfer and scaleup, manufacturing operations and investigations, CRO/CMO management, continuous improvement, regulatory requirements, and product launches.

Hervé Broly, PhD

Hervé is an internationally recognized bioprocess expert with over 42 years of experience in the development, manufacture and validation of biotech processes. He is credited with 21 patents and has authored 69 scientific papers. Over his 35-years career at Merck-Serono, he served as VicePresident of the Process Development Department. Hervés expertise spans all CMC aspects of biotechnological products for IND/CTA and BLA/MAA applications, leading to the approval of several BLA/MAA submissions. He has extensive experience in creating high-quality, compliant CMC regulatory documents and developing strategies for complex CMC challenges. Hervé has also played a crucial role in health authority interactions and inspections at company sites.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img WHO SHOULD ATTEND

-Regulatory professionals (CMC) responsible for creating a dossier
-Heads of CMC functions (e.g., Cell Line Development, Drug Substance Process Development, Analytical Development, Formulation and Drug Product Development)
-CMC Project Leaders
-Quality Assurance professionals
-Any other professionals responsible for generating data to be shared with regulatory authorities

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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