CMC Regulatory Compliance for ATMPs

    27 – 29 September 2023, live online training


    This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging ATMP topics. You will learn how to develop good CMC-compliant regulatory practices and avoid market-approval delays. This course is suitable for all those involved in CMC development and implementation for ATMPs.

    Learning Objectives

    • Understanding emerging Regulatory trends and Quality for ATMPs
    • The criticality of Operational Excellence in ATMP manufacturing
    • Advanced risk management for ATMPs
    • Differences needed for autologous and allogeneic cell therapies
    • Key starting materials and classifications
    • Translate an effective CMC strategy into your regulatory submission for ATMPs
    • Learn how to conduct a comparability study
    • Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of ATMPs.
    • Learn how to interact with the regulatory agencies; manage discussions and defend studies and strategies
    • Avoid delays in clinical development and market approval
    • How to deal with post-approval changes

    Key Topics

      • Operational Excellence and alignment of business and CMC drivers
      • Important and emerging CMC regulatory issues – problems and challenges
      • CMC regulatory compliance for ATMPs – EMA & FDA
      • Quality Risk Management and Quality by Design (QbD) principles for ATMPs
      • Change management for ATMPs; FMEA de-risking, tech transfer and CMC activities
      • Non-GMP materials, systems and control – making compliance and phase-appropriate acceptance
      • Analytical, storage, stability, comparability and retention for ATMPs
      • Comparability post Manufacturing process changes for ATMPs
      • Handling & Supply – Product considerations, logistics, storage, supply, recall/destroy
      • Interacting with regulatory authorities

    Who should attend?

    • QA/QC Managers
    • Regulatory Affairs Managers
    • CMC Managers/ Heads
    • Analytical Scientists
    • Development Scientists
    • Manufacturing
    • Process Development
    • Product Stability Managers
    • R&D Scientists
    • VC/investors in ATMPs

    Past delegate profile

    • CMC Project Manager, Mithra Pharmaceuticals
    • Regulatory Affairs Project Manager, Lonza
    • Senior Manager, European Central Regulatory Affairs, Mylan/Viatris
    • Head of Manufacturing, Biotalys
    • Head R&D Development Unit, GSK Vaccines
    • Senior Manager, Regulatory CMC, Takeda Manufacturing
    • Associate Manager Regulatory Information Management, Regeneron
    • CMC Lead, Uniqure
    • Regulatory Affairs Specialist, Novavax
    • Associate LI, Regulatory Affairs CMC, Gilead Sciences
    • QC Manager, Bayer
    • Regulatory Affairs Specialist, CSL Behring

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Digital and LinkedIn certificates


    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 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. His regulatory and licensing experience covers the MHRA, EMA and FDA.

    CMC Regulatory Compliance for ATMPs

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 1 997 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Online workbook & materials

    Recorded sessions for 7 days


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori
    +421 222 200 543

    Training Details
    • Start Date
      27. September 2023
      12:00 PM Vienna time
      11:00 AM London time
      06:00 AM New York time
      03:00 AM Los Angeles time
    • End Date
      29. September 2023
    What participants said about this course

    "It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."
    Tech Transfer Lead, Novartis

    "Practical examples were extremely useful and well presented."
    Senior Development Specialist, Bioton

    "Diving into the case studies and the ensuing discussion and learnings were great."
    Regulatory Affairs Specialist, Csl Behring

    "Excellent work of the lecturer, good materials, clear explanations."
    Clinical Pharmacologist, Boehringer Ingelheim

    "You succeed only when you are trained enough! Trust Symmetric's Training Team to achieve your goals."
    Analytical Developer, Gedeon Richter

    "Thank you for sharing all the links and informative material. Very professional organization and execution."
    Manufacturing Manager, Thermo Fisher Scientific

    "Very well organized event. Thanks and hope to work-learn from you again soon."
    Deputy Manager of Solid Dosage Forms Plant, Gedeon Richter

    "Many thanks for the invitation, organization of the training and the atmosphere. I found the course very well organised and presented."
    Formulation Manager, Curia