CMC Regulatory Compliance for Biological Drug Products

    New Dates TBA, live online training


    This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging biological products. 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.

    Learning Objectives

    • Translate an effective biologics CMC strategy into an effective regulatory submission
    • Learn how to conduct a comparability study
    • Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of biologic products.
    • Learn how to interact with the regulatory agencies; manage discussions and defend studies
    • Avoid delays in clinical development and market approval
    • How to deal with post-approval changes

    Key Topics

    • CMC regulatory compliance for biologics – EMA & FDA
    • Quality by Design (QbD) principles for biologics manufacturing
    • Change management for biologics
    • Analytical, stability and biological comparability studies
    • Biological comparability post Manufacturing process changes
    • 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

    Past delegate profile

    • CMC Project Manager,┬áMithra 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

    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 30 days
    • Digital and LinkedIn certificates


    Biotherapeutics Consultant
    Helge Neidhardt has over 30 years of pharmaceutical development experience with biologics covering projects on high purity natural proteins, recombinant proteins, monoclonal and conjugated antibodies. He worked at Aventis Behring and at Sanofi in different responsibilities, leading internal as well as collaborative CMC projects through all stages of development with EMA and FDA.

    CMC Regulatory Compliance for Biological Drug Products

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

    Online Participation
    1 650  Price incl. VAT: 1 650 
    Equivalent of approx. 1 777 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


    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
    What participants said about this course

    "Helge is a very professional trainer and has extensive knowledge of the subject."
    CMC Documentation Manager, Bayer

    "Overall a great course and I got what I was looking for."
    Regulatory Affairs Project Manager, Lonza Biologics

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