Date to be announced
Contact us for more infoTRAINING TIMES
Gain a clear understanding of global frameworks and develop effective CMC strategies to ensure compliance and product quality
Learn how to implement robust QC/QA measures, apply QbD principles, and manage formulation risks to avoid costly delays
Explore the specifics of ADC manufacturing processes, analytical methods, stability studies, and comparability assessments
Build confidence in handling post-approval changes, lifecycle management, and stay ahead with insights into evolving ADC developments
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.
Learn the key guidelines and compliance expectations governing antibody–drug conjugates
Design effective CMC approaches to ensure consistent product quality and regulatory alignment
Implement QC/QA measures across the lifecycle to mitigate risks and support compliance
Explore the unique process and production challenges involved in ADC development
Use proven techniques for characterisation, stability testing, and comparability assessments
Navigate change control processes effectively to maintain compliance throughout the product lifecycle
Apply best practices in formulation risk management and Quality by Design to strengthen development
Understand the latest developments in ADC science and regulation to accelerate clinical and market success
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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