In-House Training
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.
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
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
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
Content of CTD Modules 2/3 Quality (ICH M4Q)
Understanding of Modules 2/3 contents
CMC: Chemistry, Manufacturing & Control
Knowledge of CMC information to be gathered
Drug Substance (DS) section
CMC: Chemistry, Manufacturing & Control
Drug Product (DP) section
Annexes section
Regional informations
Benefits fom ICH Q12 (post-approval CMC changes)
Differences in Modules 2/3 content for IMPD/IND vs MAA/BLA
Phase appropriate informations
Speed to First in Human
CMC package prior to Phase I, II and III
How to manage CMC data in case of accelerated programs
Be ready to dossier submission
Questions & Answers
Please contact us at mylene.talabardon@biotechnologyconsultant.com