Advanced CMC Masterclass for Biologics: Mastering Regulatory Submission Requirements

Introduction:

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.

Trainer Profiles:

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-year career at Merck-Serono, he served as Vice-President of the Process Development Department. Hervé's 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.

Mylène TALABARDON, PhD

Mylène brings 25 years of extensive experience in the biotechnology industry, having worked with renowned companies such as BiogenIdec, 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 scale-up, manufacturing operations and investigations, CRO/CMO management, continuous improvement, regulatory requirements, and product launches.

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Key Learning Objectives:

• A comprehensive review of Chemistry, Manufacturing, and Control (CMC) data to be included in an Investigational New Drug application (IND)/Investigational Medicinal Product Dossier (IMPD) and Biological License Application (BLA)/Marketing License Application (MAA) for new biotechnological products
• The format, structure, and content of information to be shared with Regulatory Authorities when submitting an application for a clinical trial or a license/marketing authorization application
• Going through each section of Module 2 and Module 3 of the CTD, listing and describing the CMC data to be provided in each Quality section
• The objectives of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and an overview of applicable CMC guidelines, highlighting differences in data content when applying for a clinical trial or a license/marketing authorization application
• What needs to be provided in an application dossier
• How to build the CMC package and create a successful IND/IMPD or BLA/MAA

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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

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Schedule:
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DAY 1: (14:00 -17:30 CET)
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About ICH

• History of ICH
• Awareness of ICH guidelines

Common Technical Document (CTD)

• Understanding of CTD structure (ICH M4)

Preclinical and clinical modules

• summary of clinical development

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