29 April – 1 May 2026
TRAINING TIMES
Gain clarity on IMPD/CTD structures, ICH quality guidelines, and data expectations for both drug substance and drug product.
From cell line development to fill-finish, learn how to manage analytical validation, stability studies, and reference standards effectively.
Apply QbD principles to design lifecycle control strategies, manage process risks, and ensure consistent product quality.
Plan and manage technology transfer, process validation, and change control while recognising common regulatory challenges unique to biologics.
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
Understand the regulatory structure of the IMPD and CTD, and how it applies to biologic product development
Apply ICH quality guidelines and Develop a clear control strategy using QbD
From cell line development through to drug product and clinical submission. Manage a plan for effective tech transfer, process validation, scale-up and change
Identify common regulatory pitfalls and strategies to avoid them
Designed for professionals who want to enhance their expertise and advance their careers
CMC Expert and Independent Consultant Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has been a company founder, COO and GMP site head/license holder, overseeing biopharma development and manufacture as well as outsourced CDMO activities. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. Len’s regulatory and licensing experience covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large pharmaceutical companies.
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