CMC Regulatory Compliance for Biological Drug Products

    18 – 20 October 2021, 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.

    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

    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


    • Training materials will be provided in digital form
    • All delegates will receive 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.
    Registration Closed
    This training is full. Please follow the link below for the February 2022 class.

    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.

    Lydia Makori
    +421 222 200 543

    Training Details