CMC Regulatory Compliance for Biological Drug Products

    12 – 14 June 2023, live online training

    Summary

    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, 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 30 days
    • Digital and LinkedIn certificates

    Trainers

    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
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 056 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 30 days

    Certificate

    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

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    • Start Date
      12. June 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
      14. June 2023
    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

    "I really enjoyed the case studies and learning from others through brainstorming. Breakout rooms were great."
    Head R&D Unit, GSK Vaccines

    "I enjoyed the breakout sessions where I was able to hear the thought process and experience of other professionals within the field"
    European Central Regulatory Affairs Manager, Mylan